Efficacy and safety of levornidazole disodium phosphate for the treatment of pelvic inflammatory disease: A multicenter, double-blind, randomized trial

Efficacy and safety of levornidazole disodium phosphate for the treatment of pelvic inflammatory disease: A multicenter, double-blind, randomized trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Efficacy and safety of levornidazole disodium phosphate for the treatment of pelvic inflammatory disease: A multicenter, double-blind, randomized trial Yanjun Wang, Shichun Ji, Zhixue You, Li Zhou, Zhenghui Fang, Xuemei Jia, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4667264/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background In this multicenter, double-blind, randomized, parallel-group study, the efficacy and safety of levornidazole and levornidazole disodium phosphate for the treatment of women with pelvic inflammatory disease (PID) were compared. Methods The women from 12 hospitals in China received a 14-day course of intravenous levornidazole at 0.5 g twice a day (Group A, n = 49) or intravenous levornidazole disodium phosphate at 1.0 g once a day (Group B, n = 49) or 0.5 g twice a day (Group C, n = 46). Results Overall, of the 144 patients in the full analysis set (FAS), 91.00% (n = 131) were included in the per-protocol set; further, 38 of these cases (29.00%) were microbiologically valid. In the FAS population, the 14-day clinical cure rates were 77.55% for Group A, 83.67% for Group B, and 82.61% for Group C ( P = 0.7446). The 14-day bacteriological clearance rates in the FAS population were 76.47% for Group A, 93.75% for Group B, and 100.00% for Group C ( P = 0.2476). Drug-related adverse events occurred less frequently in Group B (38.78%) than in Group A (61.22%; P = 0.025). Conclusions These results indicate that daily administration of levornidazole disodium phosphate as a concentration-dependent antibacterial agent antibacterial agent for 14 days was as clinically and bacteriologically efficacious for women with PID as levornidazole twice daily for 14 days. Moreover, the former was associated with significantly fewer drug-related adverse events. Trial registration: ChiCTR2300073123 registered on 03/07/2023 ( https://www.chictr.org.cn/showproj.html?proj=196700 ). pelvic inflammatory disease levornidazole disodium phosphate multicenter randomized controlled double-blind Figures Figure 1 Background Pelvic inflammatory disease (PID) involves a spectra of upper genital tract inflammations, including endometritis, salpingitis, parametritis, oophoritis, tubo-ovarian abscess, and/or pelvic peritonitis [ 1 , 2 ]. PID affects sexually active young women, often caused by STIs, with early treatment crucial to prevent severe complications [ 3 – 5 ]. PID most commonly occurs among women with sexually transmitted diseases; women with PID account for 1–2% of the female sexually mature population. Moreover, there are severe regional differences in terms of the incidence worldwide [ 6 ]. PID is usually caused by infections ascending from the vagina and endocervix. Women of reproductive age and sexually active adolescents are at high risk of PID. When untreated or incompletely treated, PID can have serious clinical consequences, including infertility, ectopic pregnancy, and chronic pelvic pain. Because of its high incidence and severe sequelae, PID is an important public health concern. However, PID cannot reliably be diagnosed based on clinical signs and symptoms; therefore, the exact incidence of it remains unknown. Price et al. reported that 1.1% of women aged 16–44 years who visit primary care physicians in England are diagnosed with PID [ 7 ]. The accuracy of the clinical diagnosis of PID is unsatisfactory [ 8 ]. However, the diagnosis of PID remains dependent on the lowest diagnostic standard [ 1 ]. The following features and symptoms occurring simultaneously should be indicative of PID. The clinical features of PID include lower abdominal pain, deep dyspareunia, abnormal bleeding (intermenstrual bleeding, postcoital bleeding, and menorrhagia) secondary to cervicitis and endometritis, and abnormal vaginal or cervical discharge; the physical signs of PID include lower abdominal tenderness, adnexal tenderness, cervical motion tenderness, and fever (> 38°C). A variety of causative agents for PID have been identified, including sexually transmitted organisms, such as Neisseria gonorrhea and Chlamydia trachomatis , as well as lower genital tract endogenous anaerobes [ 9 ]. Additionally, PID may be caused by Mycoplasma genitalium and Ureaplasma urealyticum in some cases [ 10 ]. The objectives of antimicrobial therapy for patients with PID include antimicrobial therapy, controlling the symptoms and preventing the late sequelae of the disease [ 11 ]. Because of the diversity of the microflora involved in PID, broad-spectrum antibiotic and combination antibiotics are recommended. Guidelines for PID management have been developed in the United States as well as in Europe [ 12 , 13 ]. The regimens recommended for improving bacteria coverage include metronidazole, a member of the nitroimidazole drug class [ 14 , 15 ]. The side effects of metronidazole include a metallic taste, nausea, transient neutropenia, and peripheral neuropathy. However, after several decades of worldwide use of metronidazole, antimicrobial resistance for it has emerged [ 16 – 18 ]. One study demonstrated that the resistance rate of Bacteroides fragilis to metronidazole was 38.46% [ 19 ]. Accordingly, much effort has been expended to explore structurally different drugs belonging to the nitroimidazole class that may be more effective against PID-causing bacteria. Levornidazole is a third-generation nitroimidazole antimicrobial that is used worldwide as an alternative to metronidazole. Levornidazole is used to treat protozoan and bacterial infections. Its mechanism of action involves reactivation by reduction of the nitro group and production of toxic derivatives and radicals [ 20 ]. The recommended dose of levornidazole is 500 mg twice daily given intravenously. Levornidazole disodium phosphate, a national class I antimicrobial, is a novel third-generation nitroimidazole antimicrobial used for the treatment of amoebiasis, trichomoniasis, and anaerobic bacterial infections. This drug exhibits greater activity and less toxicity than metronidazole [ 21 , 22 ]. In cases of PID or appendicitis, 1.0 g of this antimicrobial is administered intravenously once daily. In this study, we compared the efficacy and safety of treating women with PID using intravenous levornidazole disodium phosphate once daily and intravenous levornidazole twice daily. Methods Study Setting This multicenter, double-blind, randomized, parallel-group study was conducted between May 2018 and January 2019 in China in strict accordance with the Declaration of Helsinki, and all clinical work was subject to the Good Clinical Practice Guidelines. Ethical approval was granted by the First Affiliated Hospital with Nanjing Medical University Medical Ethics Committee. Before any study procedures were performed, full written informed consent was obtained from all participants. All patients were evaluated at the following visits: pretreatment visit (24 hours before study drug initiation), in-therapy visit (days 2–10), first visit after treatment, and a test-of-cure (TOC) visit. Diagnostic Criteria The diagnosis of PID was based on the presence of all following signs and symptoms: pelvic discomfort, lower abdominal tenderness, and cervical motion tenderness as well as at least one of the following signs: pyrexia (axillary temperature > 37.8°C), a white blood cell (WBC) count > 10 × 10 9 /L on routine blood examination, mucopurulent cervical discharge, elevated vaginal discharge WBC as determined via microscopy (> 15/HP), and elevated C-reactive protein. Inclusion and Exclusion Criteria The study included women with PID aged 18–65 years. The exclusion criteria for this study were allergy to nitroimidazole, impaired liver or renal function, recent delivery or abortion, severe systemic diseases likely to affect therapy (e.g., cardiovascular abnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy), and a history of surgery in the previous 1 month. Randomization, Blinding, and Interventions Before treatment, participants were assigned to two groups receiving levornidazole disodium phosphate or one group receiving levornidazole. Group assignment was conducted using computer-generated random numbers. The machine and drug numbers were generated by the proc plan process of SAS 9.4 version. A random list of patients was created using the block randomization method in a 1:1:1 ratio for the three groups. We sealed the group assignment information in secure opaque envelopes numbered in sequence. Each envelope was opened by the administering clinician just before treatment. Participants, personnel administering the treatments, and outcome assessors were blinded to the group assignments. Group A (control) received 0.5 g of levornidazole intravenously twice a day for 7 days, Group B received 1.0 g of levornidazole disodium phosphate intravenously once a day for 7 days, and Group C received 0.5 g of levornidazole disodium phosphate intravenously twice a day for 7 days. All patients were switched to oral medication after 7 days of intravenous infusion, which included one capsule of levofloxacin hydrochloride (0.1 g) twice a day, followed by two capsules of ornidazole (500 mg) twice a day for 7 consecutive days, resulting in a treatment duration of 14 days. Levornidazole disodium phosphate was purchased from Yangzijiang Pharmaceutical Co., Ltd., China (approval batch No. 17072011 by CFDA). Levornidazole was purchased from Sanhome Pharmaceutical Co., Ltd. (Nanjing, China; approval batch No. 17121241 by CFDA). Microbiological assessments were performed on endocervical specimens at all three instances, including before treatment, at the first visit after treatment, and at the TOC visit. Safety evaluations, including patient compliance assessments, physical examinations, and clinical laboratory assessments, were also performed before treatment, at the first visit after treatment, and at the TOC visit. Primary Outcomes Clinical Efficacy The primary outcome of this study included the clinical efficacy after 14 days of treatment, which was determined based on improvement in the clinical signs and symptoms in patients with PID. Based on the evaluation criteria, the curative effect was recorded as cure or failure as follows: (1) the effect was considered as cure when the patient’s signs and symptoms at follow-up were resolved, when the condition disappeared or all functions returned to normal, and nonmicrobiological indicators such as imaging and laboratory examination were normal. (2) The effect was considered as failure when, at the end of treatment and follow-up, all signs and symptoms were the same as those at the time of enrollment or did not completely disappear or worsen, when there were new signs or symptoms of the disease, and/or when other antibacterial treatment measures for the disease had to be continued. Secondary Outcomes Bacteriological Efficacy Bacteriological efficacy after 7 and 14 days of treatment was determined based on the microbiological clearance, which was recorded as Clear, Assumed Clear, Unclear, Assumed Unclear; or Other, which referred to other common outcomes by microbial outcome, such as flora alternation, double infection, recurrence, and colonization. Comprehensive Efficacy Comprehensive efficacy evaluation refers to the comprehensive analysis and judgment of the signs and symptoms and the results of imaging, laboratory examination, and pathogenic examination of patients with positive bacterial culture before and after treatment. Efficacy was evaluated after comprehensive consideration of the clinical and bacteriological results and was categorized into recovery and invalidity. Recovery refers to patients who are clinically cured at the post-treatment visit and exhibit bacterial clearance or presumed clearance; invalidity refers to patients who are clinically inactive or exhibit no bacterial clearance, presumed nonclearance or partial clearance, or both at the end of treatment visit. If one of the patient’s clinical and bacteriological outcomes was invalidity and the other was missing, the combined treatment effect was considered invalidity. Safety Evaluations Data from all patients who received at least dose of the study drug were used to assess the causality and severity of adverse events, including standard laboratory tests, vital signs examination, and adverse events. Statistical Analysis Intention-to-treat (ITT) and per-protocol set (PPS) were used for data analysis. FAS population, referred to as the ITT group, included all randomized participants with at least one observation after randomization under ITT principles. mFAS included those from FAS with positive bacterial cultures. PPS, including all women fulfilling the study inclusion criterion and those who complied with the protocol, was subjected to efficacy analysis. mPPS included those from PPS with positive bacterial cultures. All statistical procedures were performed on SAS 9.4. Two-sided testing was performed for all analyzes, with a significance level of 0.05; a 95% confidence interval was calculated for the difference. Results Patient Recruitment A total of 150 women with PID were enrolled in this study, and 146 of these were randomized. Of these, 144 patients had primary outcome data available for analysis (Fig. 1 ). Participant Characteristics There were no significant differences between the treatment groups in terms of demographic characteristics, such as age, ethnicity, height, weight, and body mass index (Table 1 ; P > 0.05). In terms of patients with a history of surgery, two (4.08%) each in Groups A and B had undergone salpingectomy. Eight (16.33%) patients in Group A had a history of previous infection, including two patients with vaginal infection, one with pelvic inflammation, and one with vulvovaginal candidiasis. In addition, one patient in Group A had a previous ectopic pregnancy. With regard to current symptoms, similar numbers of patients in Groups A, B, and C had vaginal infections (14.29%, 16.33%, and 17.39%), bacterial vulvovaginitis (2.04%, 0.00%, and 2.17%), and oophoritic cysts (2.04%, 2.04%, and 0.00%), respectively. Medical history and current medical conditions might be related to the occurrence of PID. Table 1 Baseline demographics and disease characteristics of patients (ITT) Item Group A Group B Group C Total Statistics P -value Age (years) N (N miss) 49(0) 49(0) 46(0) 144(0) F = 0.79 0.4571 Mean ± Std 38.41 ± 10.41 36.31 ± 7.02 36.65 ± 8.81 37.13 ± 8.84 M (Q1, Q3) 39.10(30.50, 47.00) 37.40(32.20, 41.70) 37.60(29.10, 43.00) 37.75(31.10, 42.95) Min, Max 18.90, 64.30 19.30, 49.00 20.00, 57.10 18.90, 64.30 Ethnicity Han 47(95.92) 46(93.88) 44(95,65) 137(95,14%) Probability 1 Others 2(4.08) 3(6.12) 2(4.35) 7(4.86%) Total 49 49 46 144 Height (cm) N (N miss) 49(0) 49(0) 46(0) 144(0) F = 0.99 0.3728 Mean ± Std 160.20 ± 5.07 159.08 ± 4.21 160.26 ± 4.60 159.84 ± 4.64 M (Q1, Q3) 160.00(157.00, 162.00) 160.00(156.00, 162.00) 160.00(158.00, 164.00) 160.00(157.00, 162.00) Min, Max 150.00, 174.00 150.00, 167.00 152.00, 173.00 150.00, 174.00 Weight (kg) N (N miss) 49(0) 49(0) 46(0) 144(0) F = 0.01 0.9882 Mean ± Std 57.23 ± 7.71 57.40 ± 7.93 57.48 ± 8.15 57.37 ± 7.87 M (Q1, Q3) 56.00(51.00, 63.00) 56.00(51.50, 62.00) 57.00(51.00, 63.00) 56.00(51.00, 63.00) Min, Max 45.00, 75.00 44.00, 75.00 43.50, 75.00 43.50, 75.00 BMI (kg/m 2 ) N (N miss) 49(0) 49(0) 46(0) 144(0) F = 0.28 0.7535 Mean ± Std 22.28 ± 2.72 22.69 ± 3.07 22.35 ± 2.90 22.44 ± 2.89 M (Q1, Q3) 21.60(20.10, 23.30) 21.50(20.50, 24.90) 22.35(20.00, 24.50) 22.05(20.15, 24.60) Min, Max 17.80, 29.30 17.20, 29.30 17.20, 29.30 17.20, 29.30 Temperature N (N miss) 48(1) 47(2) 46(0) 141(3) F = 3.13 0.0469 Mean ± Std 36.58 ± 0.30 36.59 ± 0.34 36.75 ± 0.46 36.64 ± 0.38 M (Q1, Q3) 36.55(36.45, 36.75) 36.50(36.50, 36.80) 36.60(36.50, 36.90) 36.60(36.50, 36.80) Min, Max 36.00, 37.40 35.50, 37.50 36.20, 38.20 35.50, 38.20 Heart rate N (N miss) 48(1) 46(3) 46(0) 140(4) F = 0.22 0.8060 Mean ± Std 77.44 ± 8.88 77.61 ± 10.00 78.63 ± 9.50 77.89 ± 9.41 M (Q1, Q3) 77.00(72.50, 80.00) 78.00(75.00, 80.00) 77.50(74.00, 83.00) 78.00(73.50, 80.00) Min, Max 59.00, 105.00 55.00, 120.00 53.00, 112.00 53.00, 120.00 Breathing N (N miss) 48(1) 47(2) 46(0) 141(3) F = 0.13 0.8765 Mean ± Std 18.85 ± 1.43 18.70 ± 1.61 18.74 ± 1.47 18.77 ± 1.50 M (Q1, Q3) 19.00(18.00, 20.00) 20.00(17.00, 20.00) 19.00(18.00, 20.00) 19.00(18.00, 20.00) Min, Max 15.00, 23.00 16.00, 20.00 14.00, 20.00 14.00, 23.00 Systolic pressure N (N miss) 46(3) 45(4) 43(3) 134(10) F = 1.22 0.2978 Mean ± Std 111.96 ± 10.81 110.98 ± 13.67 114.88 ± 11.84 112.57 ± 12.18 M (Q1, Q3) 110.00(104.00, 120.00) 109.00(103.00, 118.00) 113.00(108.00, 120.00) 110.00(105.00, 120.00) Min, Max 91.00, 138.00 89.00, 152.00 94.00, 152.00 89.00, 152.00 Diastolic pressure N (N miss) 46(3) 45(4) 43(3) 134(10) F = 0.56 0.5749 Mean ± Std 70.67 ± 8.94 71.29 ± 10.15 72.67 ± 8.15 71.52 ± 9.10 M (Q1, Q3) 68.50(63.00, 77.00) 70.00(64.00, 79.00) 71.00(68.00, 78.00) 70.00(65.00, 78.00) Min, Max 59.00, 91.00 52.00, 93.00 59.00, 91.00 52.00, 93.00 Previous surgery N (%) 22(44.90) 26(53.06) 22(47.83) 0.7278 Previous infection N (%) 8(16.33) 4(8.16) 5(10.87) 0.4706 Previous ectopic pregnancy N (%) 1(2.04) 0(0.00) 0(0.00) 1.0000 Vaginal infection N (%) 7(14.29) 8(16.33) 8(17.39) 0.9590 Bacterial vulvovaginitis N (%) 1(2.04) 0(0.00) 1(2.17) 0.7668 Oophoritic cyst N (%) 1(2.04) 1(2.04) 0(0.00) 1.0000 Group A: 0.5 g of levornidazole intravenous infusion twice a day for 7 days, followed by oral medication for 7 days; Group B: 1.0 g of levornidazole disodium phosphate intravenous infusion once a day for 7 days, followed by oral medication for 7 days; Group C: 0.5 g of levornidazole disodium phosphate intravenous infusion twice a day for 7 days, followed by oral medication for 7 days Microbiology Overall, 29.17% (42/144) of all patients tested positive for bacteria. Prevotella bivia (13 strains, 25.49%) was the common pathogen, followed by Veillonella (six strains, 11.76%), anaerobic Streptococcus (five strains, 9.80%), and Finegoldiamagna (four strains, 7.84%; Table 2 ). Table 2 Positive bacterial culture before medication Group A Group B Group C Total Statistics P -value Patients 49 49 46 144 Probability 0.2327 Postive(%) 17(34.69) 16(32.65) 9(19.57) 42(29.17%) Peptoniphilus asaccharolyticus 2 1 0 3 P.asaccharolyticus 1 0 0 1 Prevotella melaninogenica 1 1 0 2 Clostridium perfringen 0 1 0 1 B.fragilis 0 2 1 3 Finegoldiamagna 2 1 1 4 Prevotella bivia 5 5 3 13 Lactobacillus fermentum 0 1 0 1 Prevotella disiens 1 1 0 2 Prevotella oralis 0 0 1 1 Actinomyces naeslundii 0 2 0 2 Anaerobic coccus Prevotella 1 0 1 2 Bifidobacterium 1 1 0 2 Micrococcus tetragenus 0 1 0 1 Veillonella 2 3 1 6 P.anaerobius 2 2 1 5 Vaginal anaerococcus spp 2 0 0 2 Total 20 22 9 51 Clinical Efficacy Among those receiving levornidazole disodium phosphate (Groups B and C), 41 and 38 patients were cured after treatment, with a cure rate of 83.67% and 82.61%, respectively. In the control Group A, 38 patients were cured, with a cure rate of 77.55%. Further, as per the clinical efficacy criteria, levornidazole disodium phosphate therapy was clinically comparable with levornidazole therapy (Table 3 ). The clinical data of PPS population were consistent with those of ITT population (Table 4 ). There was no significant difference between the groups in terms of blood, urine, liver, and kidney functions ( P > 0.05). Table 3 Fourteen-day clinical efficacy (FAS) Group A Group B Group C P -value n 49 49 46 0.7446 Cure 38 41 38 Cure rate (%) 77.55 83.67 82.61 95% CI (63.38, 88.23) (70.34, 92.68) (68.58, 92.18) Group comparation A-B B-C A-C Rate difference -6.12 1.06 -5.06 95%CI (-26.44, 14.58) (-19.13, 21.27) (-24.92, 15.38) Table 4 Fourteen-day clinical efficacy (PPS) Group A Group B Group C P -value n 45 44 42 0.3332 Cure 36 40 36 Cure rate (%) 80 90.91 85.71 95% CI (65.40, 90.42) (78.33, 97.47) (71.46, 94.57) Group comparation A-B B-C A-C Rate difference -10.91 5.19 -5.71 95%CI (-31.27, 9.52) (-15.57, 26.47) (-26.68, 15.66) Bacteriological Efficacy A total of 25 bacterial strains were culture-positive in Groups B and C before treatment, of which 15 strains (93.75%) in Group B and 9 (100.00%) in Group C were eliminated after treatment. In total, 17 bacterial strains in the control Group A were detected before treatment, among which 13 strains were eliminated (clearance rate, 76.47%) after treatment, whereas 2 strains were detected. Although the clearance rates for Groups B and C was higher than that of Group A, this difference was not statistically significant ( P = 0.2476; Table 5 ). The bacteriological efficacy of each group after 7 days of treatment was similar to that after 14 days of treatment, with a clearance rates of 82.35%, 81.25%, and 77.78% for Groups A, B, and C, respectively. The bacteriological efficacy of PPS was consistent with that of the ITT population. Table 5 Fourteen-day bacteriological efficacy (mFAS) Bacteriological Efficacy Group A Group B Group C P -value Clear(%) 13(76.47) 15(93.75) 9(100.00) 0.2476 95% CI (50.10, 93.19) (69.77, 99.84) (66.37, 100.00) Assumed clear 0(0.00) 0(0.00) 0(0.00) Unclear 2(11.76) 0(0.00) 0(0.00) Assumed unclear 0(0.00) 0(0.00) 0(0.00) Other 2(11.76) 0(0.00) 0(0.00) Missing 0(0.00) 1(6.25) 0(0.00) Total 17 16 9 Group comparation A-B B-C A-C Rate difference -17.28 -6.25 -23.53 95%CI (-49.16, 15.85) (-44.47, 32.86) (-60.01, 17.86) Comprehensive Efficacy According to the comprehensive efficacy evaluation mentioned above, 14 and 8 patients were categorized under recovery after 14 days of treatment in the Groups B and C with recovery rates of 87.50% and 88.89%, respectively. In the control Group A, 11 cases were categorized under recovery, with a recovery rate of 64.71%. Based on the criteria for comprehensive efficacy, levornidazole disodium phosphate therapy was clinically comparable to levornidazole therapy (Table 6 ). Moreover, the comprehensive efficacy data after the 7-day treatment was consistent with those after 14-day treatment. Similar results were observed on comparing the total scores of the clinical signs and symptoms of each group with the baseline change value after treatment. After 3, 7, and 14 days of treatment, the total score of clinical signs and symptoms in each group decreased compared with baseline (Table 7 ). Table 6 Fourteen-day comprehensive efficacy (mFAS) Group A Group B Group C P -value n 17 16 9 0.2951 Cure 11 14 8 Cure rate (%) 64.71 87.5 88.89 95% CI (38.33, 85.79) (61.65, 98.45) (51.75, 99.72) Group comparation A-B B-C A-C Rate difference -22.79 -1.39 -24.18 95%CI (-54.29, 9.89) (-40.95, 37.93) (-60.01, 17.84) Table 7 Comparison of changes in the total scores of clinical signs and symptoms from baseline to those after treatment (mFAS)* Time Group A Group B Group C Statistics P -value 3 days after treatment N (N miss) 44(5) 42(7) 39(7) F = 1.72 0.1841 Mean ± Std -3.02 ± 1.72 -2.43 ± 1.45 -2.41 ± 2.02 95% CI -7.00, 0.00 -7.00, 1.00 -6.00, 2.00 Min, Max -3.55, -2.50 -2.88, -1.98 -3.07, -1.75 t 11.67 10.85 7.44 P -value < 0.0001 < 0.0001 < 0.0001 7 days after treatment N (N miss) 47(2) 44(5) 42(3) F = 1.39 0.2533 Mean ± Std -4.26 ± 1.85 -3.70 ± 1.96 -4.35 ± 2.08 95% CI -8.00, 0.00 -9.00, 1.00 -9.00, -1.00 Min, Max -4.80, -3.71 -4.30, -3.11 -4.99, -3.71 t 15.79 12.54 13.71 P -value < 0.0001 < 0.0001 < 0.0001 14 days after treatment N (N miss) 47(2) 47(2) 43(3) F = 1.13 0.3273 Mean ± Std -4.72 ± 1.56 -4.26 ± 1.93 -4.77 ± 1.95 95% CI -8.00, -1.00 -8.00, 1.00 -9.00, -1.00 Min, Max -5.18, -4.27 -4.82, -3.69 -5.37, -4.17 t 20.81 15.13 16.03 P -value < 0.0001 < 0.0001 < 0.0001 * Statistical analysis: one-way analysis of variance Safety In terms of safety, in the ITT population, adverse events occurred more frequently in Group A (30/49, 61.22%) than in Groups B and C (Group B: 19/49, 38.78%; Group C: 23/46, 50.00%; P = 0.09; Table 8 ). All adverse events were mild in severity, except for two cases in Group C: one with endometrorrhagia and one with hypertension. The most common adverse reactions occurred in the control Group A, including skin or subcutaneous tissue disorders and abnormal laboratory values, such as decreased WBC count (5/49, 10.20%), decreased neutrophil count (3/49, 6.12%), elevated monocyte percentage (1/49, 2.04%), decreased lymphocyte count (1/49, 2.04%), erythema (1/49, 2.04%), erythra (1/49, 2.04%), and pruritus (1/49, 2.04%). In the groups treated with levornidazole disodium phosphate, gastrointestinal disorders occurred more frequently than in Group C, including nausea (3/46, 6.52%); diarrhea (2/46, 4.35%); and abdominal discomfort, abdominal pain, and vomiting in 2.17% (1/46). Moreover, there were no significant differences in the laboratory parameters among Group A, B, and C. Chi-square tests were performed to evaluate the differences in the incidence of adverse events (61.22% vs. 38.78%, Pearson chi = 4.9388, P = 0.026) and adverse reactions (38.78% vs. 18.37%, Pearson chi = 5.000, P = 0.025) between Groups A and B, indicating significant differences between the two groups (Table 9 ). Table 8 Comparison of adverse events and adverse reactions* Group A Group B Group C P -value Times Cases (%) Times Cases (%) Times Cases (%) AE 67 30(61.22) 42 19(38.78) 65 23(50.00) 0.0926 AR 35 19(38.78) 15 9(18.37) 21 10(21.74) 0.0588 SAE 0 0(0.00) 0 0(0.00) 2 2(4.35) 0.1005 SAR 0 0(0.00) 0 0(0.00) 0 0(0.00) *AE, adverse events; AR, adverse reactions; SAE, serious adverse events; SAR, serious adverse reactions Adverse reactions refer to adverse events with a test drug relationship of “definitely related,” “very likely related,” or “possibly related.” Table 9 Adverse reactions in Groups A and B* Group A Group B Pearson chi P -value Cases (%) Cases (%) AE 19 (38.78) 9 (18.37) 5.0000 0.025 Non AE 30 (61.22) 40 (81.63) *AE, adverse events Discussion PID mostly occurs among sexually active women and is mainly caused by poor sexual hygiene, lower genital tract infection, pelvic surgery, and the direct spread of an inflammatory infection from the adjacent organs. According to a recent study on women with PID, gonococcal or chlamydia infection is present in < 50% of the women with PID, whereas infection by Mycoplasma genitalium , respiratory pathogens, and bacterial groups related to bacterial vaginosis may account for a large proportion of women with PID [ 23 ]. The main intervention for PID includes broad-spectrum antibiotics against C. trachomatis , N. gonorrhea , and anaerobic bacteria [ 24 ]. The objectives of PID treatment include eliminating reproductive tract pathogens, resolving clinical signs and symptoms as a short-term goal, and preventing sequelae, such as infertility, ectopic pregnancy, and chronic pelvic pain, as a long-term goal [ 9 ]. Our study suggests that for women with PID, intravenous levornidazole disodium phosphate administered once a day has clinically better or comparable therapeutic efficacy and safety compared with intravenous levornidazole administered twice a day, although the difference is not significant. A national multicenter study in China revealed that the common PID-causing pathogens were chlamydia (19.9%), U. urealyticum or Mycoplasma hominis (32.4%), and anaerobic bacteria (25%) and that most cases were mixed infections [ 6 ]. An in-depth analysis of the PID Evaluation and Clinical Health (PEACH) study suggested that patients with PID infected with C. trachomatis or M. genitalium alone had symptoms that lasted significantly longer than those among patients with gonococcal infection or mixed infection before seeking medical treatment [ 25 ]. Therefore, when diagnosing and treating PID, clinicians not only need to correct acute symptoms but also need to pay attention to subclinical infection symptoms to prevent serious complications to the greatest extent. After PID is clinically diagnosed, treatment may be initiated without waiting for the results of pathogen examination to avoid the adverse consequences of treatment delay [ 1 ]. In the recent years, guidelines for the diagnosis and treatment of PID among countries have included the same principles of antibiotic use, and the vast majority of regimens include antibiotic combination treatment. However, there are some differences in terms of the recommended medication, with metronidazole administered as an intravenous infusion or as a multiroute regimen [ 1 , 12 , 13 , 26 ]. Levamisole is widely used as an alternative to metronidazole; levamisole diphosphate is a third-generation nitroimidazole antibacterial agent and a national class of antimicrobials. Pharmacokinetic studies on levornidazole disodium phosphate have demonstrated the rapid metabolism to levononazole after administration, and the pharmacokinetic profile of levononazole, the major metabolite, is generally consistent with that of levononazole when administered equimolarly. In addition, the organismal exposure of levononazole increases in proportion to the dose administered, indicating that levornidazole disodium phosphate is a concentration-dependent antibiotic [ 27 ]. Disodium levornidazole phosphate injection was shown to be well tolerated by healthy Chinese subjects after multiple-dose administration (0.5 g twice a day and 1.0 g once a day) in a multiple-dose trial, and the safety and tolerability of the 1.0-g dosage was superior than the other [ 28 ]. This finding is consistent with those of our study. Levornidazole disodium phosphate therapy was found to be clinically comparable with levornidazole therapy (cure rates of 77.55%, 83.67%, and 82.61% in Groups A, B, and C, respectively), whereas the occurrence of drug-related adverse events was significantly lower in Groups B and C than in Group A. Conclusions Levornidazole disodium phosphate therapy was found to be clinically comparable with levornidazole therapy in terms of the criteria of clinical efficacy, bacteriological efficacy, and comprehensive efficacy, although the former was associated with significantly fewer drug-related adverse events. Thus, our study suggests that 0.1 g of levornidazole disodium phosphate once a day or 0.5 g twice a day is an effective therapeutic option for patients with PID and that the treatment course should span 14 days. Abbreviations FAS full analysis set ITT intention-to-treat PID pelvic inflammatory disease PPS per-protocol set WBC white blood cell Declarations Ethics approval and consent to participate The study was conducted according to the Declaration of Helsinki and ethical approval was granted by the First Affiliated Hospital with Nanjing Medical University Medical Ethics Committee (Approval No. 2016L10000). Written informed consent was obtained from participants. Consent for publication Not applicable. Availability of data and materials The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. Competing interests YW and SJ were from Yangtze River Pharmaceutical Group. The other authors declare that they have no competing interests. Funding The study did not receive any financial support from grants. Authors' contributions YW contributed to study design and drafting of the manuscript. SJ, ZY and LZ contributed to data collection. ZF, XJ and MX contributed to statistical analysis. YL and JK contributed to editing of the manuscript. All authors have read and approved the final manuscript. Acknowledgements Not applicable. References Collaborative Group on infectious diseases doOaG, Chinese Medical Association. Diagnosis and treatment of pelvic inflammatory diseases (2019 Revision). Chin J Obstet Gynecol. 2019;54:433–7. Levin G, Dior UP, Gilad R, Benshushan A, Shushan A, Rottenstreich A. Pelvic inflammatory disease among users and non-users of an intrauterine device. J Obstet Gynaecol. 2021;41:118–23. Curry A, Williams T, Penny ML. Pelvic inflammatory disease: diagnosis, management, and prevention. Am Fam Physician. 2019;100:357–64. Greydanus DE, Cabral MD, Patel DR. Pelvic inflammatory disease in the adolescent and young adult: An update. Dis Mon. 2022;68:101287. Jennings LK, Krywko DM. Pelvic Inflammatory Disease. In: StatPearls. edn. Treasure Island (FL): StatPearls Publishing Copyright © 2024, StatPearls Publishing LLC.; 2024. Liu X, Liao Q. A nationwide study of pathogenic microorganisms and treatment options for pelvic inflammatory diseases. In: Proceedings of the first National Academic Conference on the progress of female reproductive tract infection research of Chinese Medical Association : 2008; 2008. Price MJ, Ades AE, Soldan K, Welton NJ, Macleod J, Simms I, DeAngelis D, Turner KM, Horner PJ. The natural history of Chlamydia trachomatis infection in women: a multi-parameter evidence synthesis. Health Technol Assess. 2016;20:1–250. Brunham RC, Gottlieb SL, Paavonen J. Pelvic inflammatory disease. N Engl J Med. 2015;372:2039–48. Mikamo H, Iwasaku K, Yamagishi Y, Matsumizu M, Nagashima M. Efficacy and safety of intravenous azithromycin followed by oral azithromycin for the treatment of acute pelvic inflammatory disease and perihepatitis in Japanese women. J Infect Chemother. 2014;20:429–35. Han T, Nolan SM, Regard M. Mycoplasma genitalium as a cause of pelvic inflammatory disease. J Pediatr Adolesc Gynecol. 2020;33:739–41. Pelvic Inflammatory Disease (PID.) [ https://www.cdc.gov/std/treatment-guidelines/pid.htm] . Prevention CfDCa: Sexually Transmitted Diseases Treatment Guideline, 2021. Morbidity and Mortality Weekly Report. 2021, 70:94 – 8. Ross J, Guaschino S, Cusini M, Jensen J. 2017 European guideline for the management of pelvic inflammatory disease. Int J STD AIDS. 2018;29:108–14. Sobel R, Sobel JD. Metronidazole for the treatment of vaginal infections. Expert Opin Pharmacother. 2015;16:1109–15. Alshame HA, Albarrak SK, Alharthy BT, Alayafi YH, Almansour RA, Nooh MI, Nouh YI, Alhendi RSA, Nouh MI, Karrar HR. Metronidazole-induced Metallic Taste: A Systematic Review and Meta-Analysis. J Pharm Res Int. 2021:307–17. Wiesenfeld HC, Meyn LA, Darville T, Macio IS, Hillier SL. A Randomized Controlled Trial of Ceftriaxone and Doxycycline, With or Without Metronidazole, for the Treatment of Acute Pelvic Inflammatory Disease. Clin Infect Dis. 2021;72:1181–9. Dean G, Soni S, Pitt R, Ross J, Sabin C, Whetham J. Treatment of mild-to-moderate pelvic inflammatory disease with a short-course azithromycin-based regimen versus ofloxacin plus metronidazole: results of a multicentre, randomised controlled trial. Sex Transm Infect. 2021;97:177–82. Verdon R. [Treatment of uncomplicated pelvic inflammatory disease: CNGOF and SPILF Pelvic Inflammatory Diseases Guidelines]. Gynecol Obstet Fertil Senol. 2019;47:418–30. Yanyan W, Yanqiu H, Sufang G, Fuquan, Junrui W. Distribution characteristics of anaerobes and drug resistance of Bacteroides fragilis in clinical infection specimens. Chin Med J. 2018;98:5. Ma L, Zhang Y-Z, Zheng Y-L, Wang Z-H, Xu Y, Kong L. Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections. Zhonghua fu Chan ke za zhi. 2010, 45:754–6. Hekun M, Jin W, Rui W, Nan B, Beibei L, Jiang C, Mingjing T, Ke W, Xue Wei J, Hui N. Pharmacokinetic study of levamisole in Chinese healthy subjects. In: Proceedings of the 13th National Symposium on chemo pharmacology of the Chinese Pharmacological Society : 2016; 2016. Wang X, Wang S, Hu C, Chen W, Shen Y, Wu X, Sun Y, Xu Q. A new pharmacological effect of levornidazole: Inhibition of NLRP3 inflammasome activation. Biochem Pharmacol. 2015;97:178–88. Hillier SL, Bernstein KT, Aral S. A Review of the Challenges and Complexities in the Diagnosis, Etiology, Epidemiology, and Pathogenesis of Pelvic Inflammatory Disease. J Infect Dis. 2021;224:S23–8. Liu ZH, Jin Z, Zhao H, Lu Y, Zhen H, Zou T. Effect and Safety of Kangfuyan Capsules () for Relieving Chronic Pelvic Pain: A Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Clinical Trial. Chin J Integr Med. 2021;27:883–90. Taylor BD, Darville T, Ferrell RE, Ness RB, Kelsey SF, Haggerty CL. Cross-sectional analysis of Toll-like receptor variants and bacterial vaginosis in African-American women with pelvic inflammatory disease. Sex Transm Infect. 2014;90:563–6. Inc. HPU. METRONIDAZOLE REDI-INFUSION. In., 2021.10 edn. accessdata.fda.gov; 2021. Zhao Q, Li-Li LI, Pei HU, Zhong W, Ding F, Jia ST, Zheng-Fang HU, Liu WB, Jiang J. Pharmacokinetics of levornidazole disodium phosphate in monkey. Acta Pharm Sinica. 2018. Cao J, Chen Q, Mei HK, Bai N, Jiang XW, Wang J, Wang R. Phase Ⅰ Clinical Trial on Safety and Tolerability of Levornidazole Disodium Phosphate for Injection in Chinese Healthy Volunteers. Chinese Journal of Pharmacovigilance. Additional Declarations Competing interest reported. YW and SJ were from Yangtze River Pharmaceutical Group. The other authors declare that they have no competing interests. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4667264","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":329045958,"identity":"7cf17e64-74ba-4c91-823c-3250763473ed","order_by":0,"name":"Yanjun Wang","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA2klEQVRIiWNgGAWjYHCCxAdgipkh4QCxWpINSNbCJkGSoxgMbiQ8q+apuWM3v53h4YGfO2oZ+Nu7EwhpSbvNc+xZcmMzQ8LB3jPHGSTOnN2AV4sZWAvb4WRmkF94244xGEjkEtZSzPPvcDIbUMvBv8RqYeZtO2zHA9RymLethrAW+zMPkiXn9h1OkABpkW07wEPQL5LtOYkf3nw7bC/ffyb549u2Ojn+9l78WhgEchKYeIBJoIGBJwHIPcyDXzkI8B8/wPgD6EAGBvYDQG4dYR2jYBSMglEw4gAAnNJPfJVnYbUAAAAASUVORK5CYII=","orcid":"","institution":"Yangtze River Pharmaceutical Group","correspondingAuthor":true,"prefix":"","firstName":"Yanjun","middleName":"","lastName":"Wang","suffix":""},{"id":329045959,"identity":"6631f4d3-9034-4e9e-9e23-ee75321d4458","order_by":1,"name":"Shichun Ji","email":"","orcid":"","institution":"Yangtze River Pharmaceutical Group","correspondingAuthor":false,"prefix":"","firstName":"Shichun","middleName":"","lastName":"Ji","suffix":""},{"id":329045960,"identity":"9bbfe8e5-bf43-4a1e-a977-3a997674bc1e","order_by":2,"name":"Zhixue You","email":"","orcid":"","institution":"the First Affiliated Hospital of Nanjing Medical University","correspondingAuthor":false,"prefix":"","firstName":"Zhixue","middleName":"","lastName":"You","suffix":""},{"id":329045961,"identity":"c59b8e6e-70a4-46e5-a5a9-0f226431ee8e","order_by":3,"name":"Li Zhou","email":"","orcid":"","institution":"Hangzhou First People's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Li","middleName":"","lastName":"Zhou","suffix":""},{"id":329045963,"identity":"cc1225ec-f1e5-4d58-b4d7-64a3b6bbf021","order_by":4,"name":"Zhenghui Fang","email":"","orcid":"","institution":"Jinan Central Hospital","correspondingAuthor":false,"prefix":"","firstName":"Zhenghui","middleName":"","lastName":"Fang","suffix":""},{"id":329045964,"identity":"a3e54abf-16ba-4e8b-8b66-ab450d76d36e","order_by":5,"name":"Xuemei Jia","email":"","orcid":"","institution":"Women's Hospital of Nanjing Medical University (Nanjing Maternal and Child Health Hospital)","correspondingAuthor":false,"prefix":"","firstName":"Xuemei","middleName":"","lastName":"Jia","suffix":""},{"id":329045966,"identity":"f9109827-ee87-429c-a75c-c68b3249c1ea","order_by":6,"name":"Meiqing Xie","email":"","orcid":"","institution":"Sun Yat-sen Memorial Hospital","correspondingAuthor":false,"prefix":"","firstName":"Meiqing","middleName":"","lastName":"Xie","suffix":""},{"id":329045967,"identity":"9647aa51-cc6e-4ae0-95ce-b31501b5d8a9","order_by":7,"name":"Yangzhi Li","email":"","orcid":"","institution":"Sun Yat-sen Memorial Hospital","correspondingAuthor":false,"prefix":"","firstName":"Yangzhi","middleName":"","lastName":"Li","suffix":""},{"id":329045968,"identity":"720b2983-3643-4046-85c7-e40303d5b8ba","order_by":8,"name":"Jiali Kang","email":"","orcid":"","institution":"Guangzhou First People's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jiali","middleName":"","lastName":"Kang","suffix":""}],"badges":[],"createdAt":"2024-07-01 10:24:56","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4667264/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4667264/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":61184242,"identity":"17c8cbd6-0ad8-4e45-bf0c-e7547049b8e7","added_by":"auto","created_at":"2024-07-26 17:11:38","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":122458,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart of the clinical trial of levornidazole disodium phosphate for pelvic inflammatory disease\u003c/p\u003e\n\u003cp\u003eGroup A received 0.5 g of levornidazole intravenous infusion twice a day for 7 days, followed by oral medication for 7 days; Group B received 1.0 g of levornidazole disodium phosphate intravenous infusion once a day for 7 days, followed by oral medication for 7 days; Group C received 0.5 g of levornidazole disodium phosphate intravenous infusion twice a day for 7 days, followed by oral medication for 7 days.\u003c/p\u003e","description":"","filename":"OnlineFigure1.png","url":"https://assets-eu.researchsquare.com/files/rs-4667264/v1/1930f9c4888caf86e4ddf61f.png"},{"id":105722352,"identity":"d6947630-1aa7-45a9-86f8-299e77a243c0","added_by":"auto","created_at":"2026-03-30 09:45:18","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1513737,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4667264/v1/da36afee-c692-4503-ace4-7ba77711ee1d.pdf"}],"financialInterests":"Competing interest reported. YW and SJ were from Yangtze River Pharmaceutical Group. The other authors declare that they have no competing interests.","formattedTitle":"Efficacy and safety of levornidazole disodium phosphate for the treatment of pelvic inflammatory disease: A multicenter, double-blind, randomized trial","fulltext":[{"header":"Background","content":"\u003cp\u003ePelvic inflammatory disease (PID) involves a spectra of upper genital tract inflammations, including endometritis, salpingitis, parametritis, oophoritis, tubo-ovarian abscess, and/or pelvic peritonitis [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. PID affects sexually active young women, often caused by STIs, with early treatment crucial to prevent severe complications [\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. PID most commonly occurs among women with sexually transmitted diseases; women with PID account for 1\u0026ndash;2% of the female sexually mature population. Moreover, there are severe regional differences in terms of the incidence worldwide [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. PID is usually caused by infections ascending from the vagina and endocervix. Women of reproductive age and sexually active adolescents are at high risk of PID. When untreated or incompletely treated, PID can have serious clinical consequences, including infertility, ectopic pregnancy, and chronic pelvic pain. Because of its high incidence and severe sequelae, PID is an important public health concern. However, PID cannot reliably be diagnosed based on clinical signs and symptoms; therefore, the exact incidence of it remains unknown. Price et al. reported that 1.1% of women aged 16\u0026ndash;44 years who visit primary care physicians in England are diagnosed with PID [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe accuracy of the clinical diagnosis of PID is unsatisfactory [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. However, the diagnosis of PID remains dependent on the lowest diagnostic standard [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The following features and symptoms occurring simultaneously should be indicative of PID. The clinical features of PID include lower abdominal pain, deep dyspareunia, abnormal bleeding (intermenstrual bleeding, postcoital bleeding, and menorrhagia) secondary to cervicitis and endometritis, and abnormal vaginal or cervical discharge; the physical signs of PID include lower abdominal tenderness, adnexal tenderness, cervical motion tenderness, and fever (\u0026gt;\u0026thinsp;38\u0026deg;C). A variety of causative agents for PID have been identified, including sexually transmitted organisms, such as \u003cem\u003eNeisseria gonorrhea\u003c/em\u003e and \u003cem\u003eChlamydia trachomatis\u003c/em\u003e, as well as lower genital tract endogenous anaerobes [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Additionally, PID may be caused by \u003cem\u003eMycoplasma genitalium\u003c/em\u003e and \u003cem\u003eUreaplasma urealyticum\u003c/em\u003e in some cases [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe objectives of antimicrobial therapy for patients with PID include antimicrobial therapy, controlling the symptoms and preventing the late sequelae of the disease [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Because of the diversity of the microflora involved in PID, broad-spectrum antibiotic and combination antibiotics are recommended. Guidelines for PID management have been developed in the United States as well as in Europe [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. The regimens recommended for improving bacteria coverage include metronidazole, a member of the nitroimidazole drug class [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. The side effects of metronidazole include a metallic taste, nausea, transient neutropenia, and peripheral neuropathy. However, after several decades of worldwide use of metronidazole, antimicrobial resistance for it has emerged [\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. One study demonstrated that the resistance rate of \u003cem\u003eBacteroides fragilis\u003c/em\u003e to metronidazole was 38.46% [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Accordingly, much effort has been expended to explore structurally different drugs belonging to the nitroimidazole class that may be more effective against PID-causing bacteria.\u003c/p\u003e \u003cp\u003eLevornidazole is a third-generation nitroimidazole antimicrobial that is used worldwide as an alternative to metronidazole. Levornidazole is used to treat protozoan and bacterial infections. Its mechanism of action involves reactivation by reduction of the nitro group and production of toxic derivatives and radicals [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. The recommended dose of levornidazole is 500 mg twice daily given intravenously.\u003c/p\u003e \u003cp\u003eLevornidazole disodium phosphate, a national class I antimicrobial, is a novel third-generation nitroimidazole antimicrobial used for the treatment of amoebiasis, trichomoniasis, and anaerobic bacterial infections. This drug exhibits greater activity and less toxicity than metronidazole [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. In cases of PID or appendicitis, 1.0 g of this antimicrobial is administered intravenously once daily. In this study, we compared the efficacy and safety of treating women with PID using intravenous levornidazole disodium phosphate once daily and intravenous levornidazole twice daily.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Setting\u003c/h2\u003e \u003cp\u003e This multicenter, double-blind, randomized, parallel-group study was conducted between May 2018 and January 2019 in China in strict accordance with the Declaration of Helsinki, and all clinical work was subject to the Good Clinical Practice Guidelines. Ethical approval was granted by the First Affiliated Hospital with Nanjing Medical University Medical Ethics Committee. Before any study procedures were performed, full written informed consent was obtained from all participants. All patients were evaluated at the following visits: pretreatment visit (24 hours before study drug initiation), in-therapy visit (days 2\u0026ndash;10), first visit after treatment, and a test-of-cure (TOC) visit.\u003c/p\u003e \u003cp\u003eDiagnostic Criteria\u003c/p\u003e \u003cp\u003eThe diagnosis of PID was based on the presence of all following signs and symptoms: pelvic discomfort, lower abdominal tenderness, and cervical motion tenderness as well as at least one of the following signs: pyrexia (axillary temperature\u0026thinsp;\u0026gt;\u0026thinsp;37.8\u0026deg;C), a white blood cell (WBC) count\u0026thinsp;\u0026gt;\u0026thinsp;10 \u0026times; 10\u003csup\u003e9\u003c/sup\u003e/L on routine blood examination, mucopurulent cervical discharge, elevated vaginal discharge WBC as determined via microscopy (\u0026gt;\u0026thinsp;15/HP), and elevated C-reactive protein.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eInclusion and Exclusion Criteria\u003c/h2\u003e \u003cp\u003eThe study included women with PID aged 18\u0026ndash;65 years. The exclusion criteria for this study were allergy to nitroimidazole, impaired liver or renal function, recent delivery or abortion, severe systemic diseases likely to affect therapy (e.g., cardiovascular abnormalities, unstable angina, high blood pressure, severe neuropathy, or epilepsy), and a history of surgery in the previous 1 month.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eRandomization, Blinding, and Interventions\u003c/h2\u003e \u003cp\u003e Before treatment, participants were assigned to two groups receiving levornidazole disodium phosphate or one group receiving levornidazole. Group assignment was conducted using computer-generated random numbers. The machine and drug numbers were generated by the proc plan process of SAS 9.4 version. A random list of patients was created using the block randomization method in a 1:1:1 ratio for the three groups. We sealed the group assignment information in secure opaque envelopes numbered in sequence. Each envelope was opened by the administering clinician just before treatment. Participants, personnel administering the treatments, and outcome assessors were blinded to the group assignments.\u003c/p\u003e \u003cp\u003eGroup A (control) received 0.5 g of levornidazole intravenously twice a day for 7 days, Group B received 1.0 g of levornidazole disodium phosphate intravenously once a day for 7 days, and Group C received 0.5 g of levornidazole disodium phosphate intravenously twice a day for 7 days. All patients were switched to oral medication after 7 days of intravenous infusion, which included one capsule of levofloxacin hydrochloride (0.1 g) twice a day, followed by two capsules of ornidazole (500 mg) twice a day for 7 consecutive days, resulting in a treatment duration of 14 days. Levornidazole disodium phosphate was purchased from Yangzijiang Pharmaceutical Co., Ltd., China (approval batch No. 17072011 by CFDA). Levornidazole was purchased from Sanhome Pharmaceutical Co., Ltd. (Nanjing, China; approval batch No. 17121241 by CFDA). Microbiological assessments were performed on endocervical specimens at all three instances, including before treatment, at the first visit after treatment, and at the TOC visit. Safety evaluations, including patient compliance assessments, physical examinations, and clinical laboratory assessments, were also performed before treatment, at the first visit after treatment, and at the TOC visit.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003ePrimary Outcomes\u003c/h2\u003e \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e \u003ch2\u003eClinical Efficacy\u003c/h2\u003e \u003cp\u003eThe primary outcome of this study included the clinical efficacy after 14 days of treatment, which was determined based on improvement in the clinical signs and symptoms in patients with PID. Based on the evaluation criteria, the curative effect was recorded as cure or failure as follows: (1) the effect was considered as cure when the patient\u0026rsquo;s signs and symptoms at follow-up were resolved, when the condition disappeared or all functions returned to normal, and nonmicrobiological indicators such as imaging and laboratory examination were normal. (2) The effect was considered as failure when, at the end of treatment and follow-up, all signs and symptoms were the same as those at the time of enrollment or did not completely disappear or worsen, when there were new signs or symptoms of the disease, and/or when other antibacterial treatment measures for the disease had to be continued.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eSecondary Outcomes\u003c/h2\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003eBacteriological Efficacy\u003c/h2\u003e \u003cp\u003eBacteriological efficacy after 7 and 14 days of treatment was determined based on the microbiological clearance, which was recorded as Clear, Assumed Clear, Unclear, Assumed Unclear; or Other, which referred to other common outcomes by microbial outcome, such as flora alternation, double infection, recurrence, and colonization.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003eComprehensive Efficacy\u003c/h2\u003e \u003cp\u003eComprehensive efficacy evaluation refers to the comprehensive analysis and judgment of the signs and symptoms and the results of imaging, laboratory examination, and pathogenic examination of patients with positive bacterial culture before and after treatment. Efficacy was evaluated after comprehensive consideration of the clinical and bacteriological results and was categorized into recovery and invalidity. Recovery refers to patients who are clinically cured at the post-treatment visit and exhibit bacterial clearance or presumed clearance; invalidity refers to patients who are clinically inactive or exhibit no bacterial clearance, presumed nonclearance or partial clearance, or both at the end of treatment visit. If one of the patient\u0026rsquo;s clinical and bacteriological outcomes was invalidity and the other was missing, the combined treatment effect was considered invalidity.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eSafety Evaluations\u003c/h2\u003e \u003cp\u003eData from all patients who received at least dose of the study drug were used to assess the causality and severity of adverse events, including standard laboratory tests, vital signs examination, and adverse events.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eIntention-to-treat (ITT) and per-protocol set (PPS) were used for data analysis. FAS population, referred to as the ITT group, included all randomized participants with at least one observation after randomization under ITT principles. mFAS included those from FAS with positive bacterial cultures. PPS, including all women fulfilling the study inclusion criterion and those who complied with the protocol, was subjected to efficacy analysis. mPPS included those from PPS with positive bacterial cultures. All statistical procedures were performed on SAS 9.4. Two-sided testing was performed for all analyzes, with a significance level of 0.05; a 95% confidence interval was calculated for the difference.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003ePatient Recruitment\u003c/h2\u003e \u003cp\u003eA total of 150 women with PID were enrolled in this study, and 146 of these were randomized. Of these, 144 patients had primary outcome data available for analysis (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eParticipant Characteristics\u003c/h2\u003e \u003cp\u003eThere were no significant differences between the treatment groups in terms of demographic characteristics, such as age, ethnicity, height, weight, and body mass index (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05). In terms of patients with a history of surgery, two (4.08%) each in Groups A and B had undergone salpingectomy. Eight (16.33%) patients in Group A had a history of previous infection, including two patients with vaginal infection, one with pelvic inflammation, and one with vulvovaginal candidiasis. In addition, one patient in Group A had a previous ectopic pregnancy. With regard to current symptoms, similar numbers of patients in Groups A, B, and C had vaginal infections (14.29%, 16.33%, and 17.39%), bacterial vulvovaginitis (2.04%, 0.00%, and 2.17%), and oophoritic cysts (2.04%, 2.04%, and 0.00%), respectively. Medical history and current medical conditions might be related to the occurrence of PID.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline demographics and disease characteristics of patients (ITT)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eItem\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup A\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup B\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eGroup C\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eStatistics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e49(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e46(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e144(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;0.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.4571\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e38.41\u0026thinsp;\u0026plusmn;\u0026thinsp;10.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36.31\u0026thinsp;\u0026plusmn;\u0026thinsp;7.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e36.65\u0026thinsp;\u0026plusmn;\u0026thinsp;8.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e37.13\u0026thinsp;\u0026plusmn;\u0026thinsp;8.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM (Q1, Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e39.10(30.50, 47.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e37.40(32.20, 41.70)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e37.60(29.10, 43.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e37.75(31.10, 42.95)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18.90, 64.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e19.30, 49.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20.00, 57.10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e18.90, 64.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEthnicity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHan\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e47(95.92)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e46(93.88)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e44(95,65)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e137(95,14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eProbability\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOthers\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(4.08)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3(6.12)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2(4.35)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7(4.86%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e144\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHeight (cm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e49(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e46(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e144(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;0.99\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.3728\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e160.20\u0026thinsp;\u0026plusmn;\u0026thinsp;5.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e159.08\u0026thinsp;\u0026plusmn;\u0026thinsp;4.21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e160.26\u0026thinsp;\u0026plusmn;\u0026thinsp;4.60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e159.84\u0026thinsp;\u0026plusmn;\u0026thinsp;4.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM (Q1, Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e160.00(157.00, 162.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e160.00(156.00, 162.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e160.00(158.00, 164.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e160.00(157.00, 162.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e150.00, 174.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e150.00, 167.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e152.00, 173.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e150.00, 174.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWeight (kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e49(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e46(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e144(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;0.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.9882\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e57.23\u0026thinsp;\u0026plusmn;\u0026thinsp;7.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e57.40\u0026thinsp;\u0026plusmn;\u0026thinsp;7.93\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e57.48\u0026thinsp;\u0026plusmn;\u0026thinsp;8.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e57.37\u0026thinsp;\u0026plusmn;\u0026thinsp;7.87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM (Q1, Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e56.00(51.00, 63.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e56.00(51.50, 62.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e57.00(51.00, 63.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e56.00(51.00, 63.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45.00, 75.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e44.00, 75.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e43.50, 75.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e43.50, 75.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI (kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e49(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e46(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e144(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.7535\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22.28\u0026thinsp;\u0026plusmn;\u0026thinsp;2.72\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e22.69\u0026thinsp;\u0026plusmn;\u0026thinsp;3.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22.35\u0026thinsp;\u0026plusmn;\u0026thinsp;2.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e22.44\u0026thinsp;\u0026plusmn;\u0026thinsp;2.89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM (Q1, Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21.60(20.10, 23.30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e21.50(20.50, 24.90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22.35(20.00, 24.50)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e22.05(20.15, 24.60)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17.80, 29.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e17.20, 29.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e17.20, 29.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e17.20, 29.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTemperature\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e48(1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e47(2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e46(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e141(3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;3.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.0469\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36.58\u0026thinsp;\u0026plusmn;\u0026thinsp;0.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36.59\u0026thinsp;\u0026plusmn;\u0026thinsp;0.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e36.75\u0026thinsp;\u0026plusmn;\u0026thinsp;0.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e36.64\u0026thinsp;\u0026plusmn;\u0026thinsp;0.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM (Q1, Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36.55(36.45, 36.75)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36.50(36.50, 36.80)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e36.60(36.50, 36.90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e36.60(36.50, 36.80)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36.00, 37.40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35.50, 37.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e36.20, 38.20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e35.50, 38.20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHeart rate\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e48(1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e46(3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e46(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e140(4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;0.22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.8060\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e77.44\u0026thinsp;\u0026plusmn;\u0026thinsp;8.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e77.61\u0026thinsp;\u0026plusmn;\u0026thinsp;10.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e78.63\u0026thinsp;\u0026plusmn;\u0026thinsp;9.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e77.89\u0026thinsp;\u0026plusmn;\u0026thinsp;9.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM (Q1, Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e77.00(72.50, 80.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78.00(75.00, 80.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e77.50(74.00, 83.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e78.00(73.50, 80.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e59.00, 105.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e55.00, 120.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e53.00, 112.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e53.00, 120.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBreathing\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e48(1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e47(2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e46(0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e141(3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;0.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.8765\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18.85\u0026thinsp;\u0026plusmn;\u0026thinsp;1.43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18.70\u0026thinsp;\u0026plusmn;\u0026thinsp;1.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e18.74\u0026thinsp;\u0026plusmn;\u0026thinsp;1.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e18.77\u0026thinsp;\u0026plusmn;\u0026thinsp;1.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM (Q1, Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19.00(18.00, 20.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e20.00(17.00, 20.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19.00(18.00, 20.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e19.00(18.00, 20.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15.00, 23.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16.00, 20.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14.00, 20.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14.00, 23.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSystolic pressure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e46(3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e45(4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e43(3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e134(10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;1.22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.2978\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e111.96\u0026thinsp;\u0026plusmn;\u0026thinsp;10.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e110.98\u0026thinsp;\u0026plusmn;\u0026thinsp;13.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e114.88\u0026thinsp;\u0026plusmn;\u0026thinsp;11.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e112.57\u0026thinsp;\u0026plusmn;\u0026thinsp;12.18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM (Q1, Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e110.00(104.00, 120.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e109.00(103.00, 118.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e113.00(108.00, 120.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e110.00(105.00, 120.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e91.00, 138.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e89.00, 152.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e94.00, 152.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e89.00, 152.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiastolic pressure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e46(3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e45(4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e43(3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e134(10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;0.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.5749\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e70.67\u0026thinsp;\u0026plusmn;\u0026thinsp;8.94\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e71.29\u0026thinsp;\u0026plusmn;\u0026thinsp;10.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e72.67\u0026thinsp;\u0026plusmn;\u0026thinsp;8.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e71.52\u0026thinsp;\u0026plusmn;\u0026thinsp;9.10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eM (Q1, Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e68.50(63.00, 77.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e70.00(64.00, 79.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e71.00(68.00, 78.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e70.00(65.00, 78.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e59.00, 91.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52.00, 93.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e59.00, 91.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e52.00, 93.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious surgery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22(44.90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26(53.06)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22(47.83)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.7278\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious infection\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8(16.33)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4(8.16)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5(10.87)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.4706\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious ectopic pregnancy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1(2.04)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1.0000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVaginal infection\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7(14.29)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8(16.33)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e8(17.39)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.9590\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBacterial vulvovaginitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1(2.04)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1(2.17)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.7668\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOophoritic cyst\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1(2.04)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1(2.04)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1.0000\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"8\"\u003eGroup A: 0.5 g of levornidazole intravenous infusion twice a day for 7 days, followed by oral medication for 7 days; Group B: 1.0 g of levornidazole disodium phosphate intravenous infusion once a day for 7 days, followed by oral medication for 7 days; Group C: 0.5 g of levornidazole disodium phosphate intravenous infusion twice a day for 7 days, followed by oral medication for 7 days\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eMicrobiology\u003c/h2\u003e \u003cp\u003eOverall, 29.17% (42/144) of all patients tested positive for bacteria. \u003cem\u003ePrevotella bivia\u003c/em\u003e (13 strains, 25.49%) was the common pathogen, followed by \u003cem\u003eVeillonella\u003c/em\u003e (six strains, 11.76%), anaerobic \u003cem\u003eStreptococcus\u003c/em\u003e (five strains, 9.80%), and \u003cem\u003eFinegoldiamagna\u003c/em\u003e (four strains, 7.84%; Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePositive bacterial culture before medication\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup A\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup B\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup C\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eStatistics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatients\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e144\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eProbability\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.2327\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePostive(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17(34.69)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16(32.65)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9(19.57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e42(29.17%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePeptoniphilus asaccharolyticus\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eP.asaccharolyticus\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePrevotella melaninogenica\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eClostridium perfringen\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eB.fragilis\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eFinegoldiamagna\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePrevotella bivia\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLactobacillus fermentum\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePrevotella disiens\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePrevotella oralis\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eActinomyces naeslundii\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eAnaerobic coccus Prevotella\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eBifidobacterium\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eMicrococcus tetragenus\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eVeillonella\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eP.anaerobius\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eVaginal anaerococcus spp\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eClinical Efficacy\u003c/h2\u003e \u003cp\u003eAmong those receiving levornidazole disodium phosphate (Groups B and C), 41 and 38 patients were cured after treatment, with a cure rate of 83.67% and 82.61%, respectively. In the control Group A, 38 patients were cured, with a cure rate of 77.55%. Further, as per the clinical efficacy criteria, levornidazole disodium phosphate therapy was clinically comparable with levornidazole therapy (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The clinical data of PPS population were consistent with those of ITT population (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e4\u003c/span\u003e). There was no significant difference between the groups in terms of blood, urine, liver, and kidney functions (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFourteen-day clinical efficacy (FAS)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup A\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup B\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup C\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.7446\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCure rate (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77.55\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e83.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e82.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(63.38, 88.23)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(70.34, 92.68)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(68.58, 92.18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroup comparation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eA-B\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eB-C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eA-C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRate difference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-6.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-5.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e95%CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(-26.44, 14.58)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(-19.13, 21.27)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(-24.92, 15.38)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFourteen-day clinical efficacy (PPS)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup A\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup B\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup C\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.3332\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCure rate (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e90.91\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e85.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(65.40, 90.42)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(78.33, 97.47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(71.46, 94.57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroup comparation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eA-B\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eB-C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eA-C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRate difference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-10.91\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-5.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e95%CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(-31.27, 9.52)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(-15.57, 26.47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(-26.68, 15.66)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eBacteriological Efficacy\u003c/h2\u003e \u003cp\u003eA total of 25 bacterial strains were culture-positive in Groups B and C before treatment, of which 15 strains (93.75%) in Group B and 9 (100.00%) in Group C were eliminated after treatment. In total, 17 bacterial strains in the control Group A were detected before treatment, among which 13 strains were eliminated (clearance rate, 76.47%) after treatment, whereas 2 strains were detected. Although the clearance rates for Groups B and C was higher than that of Group A, this difference was not statistically significant (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.2476; Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). The bacteriological efficacy of each group after 7 days of treatment was similar to that after 14 days of treatment, with a clearance rates of 82.35%, 81.25%, and 77.78% for Groups A, B, and C, respectively. The bacteriological efficacy of PPS was consistent with that of the ITT population.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFourteen-day bacteriological efficacy (mFAS)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBacteriological Efficacy\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup A\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup B\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup C\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eClear(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13(76.47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15(93.75)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9(100.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.2476\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(50.10, 93.19)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(69.77, 99.84)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(66.37, 100.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAssumed clear\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnclear\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(11.76)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAssumed unclear\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(11.76)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMissing\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1(6.25)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroup comparation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eA-B\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eB-C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eA-C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRate difference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-17.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-6.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-23.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e95%CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(-49.16, 15.85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(-44.47, 32.86)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(-60.01, 17.86)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eComprehensive Efficacy\u003c/h2\u003e \u003cp\u003eAccording to the comprehensive efficacy evaluation mentioned above, 14 and 8 patients were categorized under recovery after 14 days of treatment in the Groups B and C with recovery rates of 87.50% and 88.89%, respectively. In the control Group A, 11 cases were categorized under recovery, with a recovery rate of 64.71%. Based on the criteria for comprehensive efficacy, levornidazole disodium phosphate therapy was clinically comparable to levornidazole therapy (Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e6\u003c/span\u003e). Moreover, the comprehensive efficacy data after the 7-day treatment was consistent with those after 14-day treatment. Similar results were observed on comparing the total scores of the clinical signs and symptoms of each group with the baseline change value after treatment. After 3, 7, and 14 days of treatment, the total score of clinical signs and symptoms in each group decreased compared with baseline (Table\u0026nbsp;\u003cspan refid=\"Tab7\" class=\"InternalRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab6\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 6\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFourteen-day comprehensive efficacy (mFAS)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup A\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup B\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup C\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.2951\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCure rate (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e64.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e87.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e88.89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(38.33, 85.79)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(61.65, 98.45)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(51.75, 99.72)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroup comparation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eA-B\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eB-C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eA-C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRate difference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-22.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-1.39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-24.18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e95%CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(-54.29, 9.89)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(-40.95, 37.93)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(-60.01, 17.84)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab7\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 7\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of changes in the total scores of clinical signs and symptoms from baseline to those after treatment (mFAS)*\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTime\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup A\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup B\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eGroup C\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eStatistics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3 days after treatment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e44(5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e42(7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e39(7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;1.72\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.1841\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-3.02\u0026thinsp;\u0026plusmn;\u0026thinsp;1.72\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-2.43\u0026thinsp;\u0026plusmn;\u0026thinsp;1.45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-2.41\u0026thinsp;\u0026plusmn;\u0026thinsp;2.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-7.00, 0.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-7.00, 1.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-6.00, 2.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-3.55, -2.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-2.88, -1.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-3.07, -1.75\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003et\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10.85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7 days after treatment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e47(2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e44(5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e42(3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;1.39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.2533\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-4.26\u0026thinsp;\u0026plusmn;\u0026thinsp;1.85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-3.70\u0026thinsp;\u0026plusmn;\u0026thinsp;1.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-4.35\u0026thinsp;\u0026plusmn;\u0026thinsp;2.08\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-8.00, 0.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-9.00, 1.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-9.00, -1.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-4.80, -3.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-4.30, -3.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-4.99, -3.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003et\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12.54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e13.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e14 days after treatment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN (N miss)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e47(2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e47(2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e43(3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eF\u0026thinsp;=\u0026thinsp;1.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.3273\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;Std\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-4.72\u0026thinsp;\u0026plusmn;\u0026thinsp;1.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-4.26\u0026thinsp;\u0026plusmn;\u0026thinsp;1.93\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-4.77\u0026thinsp;\u0026plusmn;\u0026thinsp;1.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-8.00, -1.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-8.00, 1.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-9.00, -1.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-5.18, -4.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-4.82, -3.69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-5.37, -4.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003et\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e16.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003e* Statistical analysis: one-way analysis of variance\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eSafety\u003c/h2\u003e \u003cp\u003eIn terms of safety, in the ITT population, adverse events occurred more frequently in Group A (30/49, 61.22%) than in Groups B and C (Group B: 19/49, 38.78%; Group C: 23/46, 50.00%; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.09; Table\u0026nbsp;\u003cspan refid=\"Tab8\" class=\"InternalRef\"\u003e8\u003c/span\u003e). All adverse events were mild in severity, except for two cases in Group C: one with endometrorrhagia and one with hypertension. The most common adverse reactions occurred in the control Group A, including skin or subcutaneous tissue disorders and abnormal laboratory values, such as decreased WBC count (5/49, 10.20%), decreased neutrophil count (3/49, 6.12%), elevated monocyte percentage (1/49, 2.04%), decreased lymphocyte count (1/49, 2.04%), erythema (1/49, 2.04%), erythra (1/49, 2.04%), and pruritus (1/49, 2.04%). In the groups treated with levornidazole disodium phosphate, gastrointestinal disorders occurred more frequently than in Group C, including nausea (3/46, 6.52%); diarrhea (2/46, 4.35%); and abdominal discomfort, abdominal pain, and vomiting in 2.17% (1/46). Moreover, there were no significant differences in the laboratory parameters among Group A, B, and C. Chi-square tests were performed to evaluate the differences in the incidence of adverse events (61.22% vs. 38.78%, Pearson chi\u0026thinsp;=\u0026thinsp;4.9388, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.026) and adverse reactions (38.78% vs. 18.37%, Pearson chi\u0026thinsp;=\u0026thinsp;5.000, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.025) between Groups A and B, indicating significant differences between the two groups (Table\u0026nbsp;\u003cspan refid=\"Tab9\" class=\"InternalRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab8\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 8\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of adverse events and adverse reactions*\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup A\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eGroup B\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eGroup C\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTimes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCases (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTimes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCases (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eTimes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eCases (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAE\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e30(61.22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e19(38.78)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e23(50.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.0926\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19(38.78)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9(18.37)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e10(21.74)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.0588\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSAE\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2(4.35)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.1005\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSAR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0(0.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"8\"\u003e*AE, adverse events; AR, adverse reactions; SAE, serious adverse events; SAR, serious adverse reactions\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"8\"\u003eAdverse reactions refer to adverse events with a test drug relationship of \u0026ldquo;definitely related,\u0026rdquo; \u0026ldquo;very likely related,\u0026rdquo; or \u0026ldquo;possibly related.\u0026rdquo;\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab9\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 9\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAdverse reactions in Groups A and B*\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup A\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup B\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePearson chi\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCases (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCases (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAE\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e19 (38.78)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9 (18.37)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5.0000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.025\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNon AE\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e30 (61.22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e40 (81.63)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003e*AE, adverse events\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003ePID mostly occurs among sexually active women and is mainly caused by poor sexual hygiene, lower genital tract infection, pelvic surgery, and the direct spread of an inflammatory infection from the adjacent organs. According to a recent study on women with PID, gonococcal or chlamydia infection is present in \u0026lt;\u0026thinsp;50% of the women with PID, whereas infection by \u003cem\u003eMycoplasma genitalium\u003c/em\u003e, respiratory pathogens, and bacterial groups related to bacterial vaginosis may account for a large proportion of women with PID [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The main intervention for PID includes broad-spectrum antibiotics against \u003cem\u003eC. trachomatis\u003c/em\u003e, \u003cem\u003eN. gonorrhea\u003c/em\u003e, and anaerobic bacteria [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. The objectives of PID treatment include eliminating reproductive tract pathogens, resolving clinical signs and symptoms as a short-term goal, and preventing sequelae, such as infertility, ectopic pregnancy, and chronic pelvic pain, as a long-term goal [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Our study suggests that for women with PID, intravenous levornidazole disodium phosphate administered once a day has clinically better or comparable therapeutic efficacy and safety compared with intravenous levornidazole administered twice a day, although the difference is not significant.\u003c/p\u003e \u003cp\u003eA national multicenter study in China revealed that the common PID-causing pathogens were chlamydia (19.9%), \u003cem\u003eU. urealyticum\u003c/em\u003e or \u003cem\u003eMycoplasma hominis\u003c/em\u003e (32.4%), and anaerobic bacteria (25%) and that most cases were mixed infections [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. An in-depth analysis of the PID Evaluation and Clinical Health (PEACH) study suggested that patients with PID infected with \u003cem\u003eC. trachomatis\u003c/em\u003e or \u003cem\u003eM. genitalium\u003c/em\u003e alone had symptoms that lasted significantly longer than those among patients with gonococcal infection or mixed infection before seeking medical treatment [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Therefore, when diagnosing and treating PID, clinicians not only need to correct acute symptoms but also need to pay attention to subclinical infection symptoms to prevent serious complications to the greatest extent. After PID is clinically diagnosed, treatment may be initiated without waiting for the results of pathogen examination to avoid the adverse consequences of treatment delay [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e In the recent years, guidelines for the diagnosis and treatment of PID among countries have included the same principles of antibiotic use, and the vast majority of regimens include antibiotic combination treatment. However, there are some differences in terms of the recommended medication, with metronidazole administered as an intravenous infusion or as a multiroute regimen [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Levamisole is widely used as an alternative to metronidazole; levamisole diphosphate is a third-generation nitroimidazole antibacterial agent and a national class of antimicrobials. Pharmacokinetic studies on levornidazole disodium phosphate have demonstrated the rapid metabolism to levononazole after administration, and the pharmacokinetic profile of levononazole, the major metabolite, is generally consistent with that of levononazole when administered equimolarly. In addition, the organismal exposure of levononazole increases in proportion to the dose administered, indicating that levornidazole disodium phosphate is a concentration-dependent antibiotic [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Disodium levornidazole phosphate injection was shown to be well tolerated by healthy Chinese subjects after multiple-dose administration (0.5 g twice a day and 1.0 g once a day) in a multiple-dose trial, and the safety and tolerability of the 1.0-g dosage was superior than the other [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. This finding is consistent with those of our study. Levornidazole disodium phosphate therapy was found to be clinically comparable with levornidazole therapy (cure rates of 77.55%, 83.67%, and 82.61% in Groups A, B, and C, respectively), whereas the occurrence of drug-related adverse events was significantly lower in Groups B and C than in Group A.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eLevornidazole disodium phosphate therapy was found to be clinically comparable with levornidazole therapy in terms of the criteria of clinical efficacy, bacteriological efficacy, and comprehensive efficacy, although the former was associated with significantly fewer drug-related adverse events. Thus, our study suggests that 0.1 g of levornidazole disodium phosphate once a day or 0.5 g twice a day is an effective therapeutic option for patients with PID and that the treatment course should span 14 days.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFAS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003efull analysis set\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eITT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eintention-to-treat\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePID\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003epelvic inflammatory disease\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePPS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eper-protocol set\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eWBC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ewhite blood cell\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThe study was conducted according to the Declaration of Helsinki and ethical approval was granted by the First Affiliated Hospital with Nanjing Medical University Medical Ethics Committee (Approval No. 2016L10000). Written informed consent was obtained from participants.\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eThe datasets used and\u0026nbsp;analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eYW and SJ were from Yangtze River Pharmaceutical Group. The other authors declare that they have no competing interests.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThe study did not receive any financial support from grants.\u003c/p\u003e\n\u003ch2\u003eAuthors\u0026apos; contributions\u003c/h2\u003e\n\u003cp\u003eYW contributed to study design and drafting of the manuscript. SJ, ZY and LZ contributed to data collection. ZF, XJ and MX contributed to statistical analysis. YL and JK contributed to editing of the manuscript. All authors have read and approved the final manuscript.\u003c/p\u003e\n\u003ch2\u003eAcknowledgements\u003c/h2\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eCollaborative Group on infectious diseases doOaG, Chinese Medical Association. Diagnosis and treatment of pelvic inflammatory diseases (2019 Revision). Chin J Obstet Gynecol. 2019;54:433\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLevin G, Dior UP, Gilad R, Benshushan A, Shushan A, Rottenstreich A. Pelvic inflammatory disease among users and non-users of an intrauterine device. J Obstet Gynaecol. 2021;41:118\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCurry A, Williams T, Penny ML. Pelvic inflammatory disease: diagnosis, management, and prevention. Am Fam Physician. 2019;100:357\u0026ndash;64.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGreydanus DE, Cabral MD, Patel DR. Pelvic inflammatory disease in the adolescent and young adult: An update. Dis Mon. 2022;68:101287.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJennings LK, Krywko DM. Pelvic Inflammatory Disease. In: \u003cem\u003eStatPearls.\u003c/em\u003e edn. Treasure Island (FL): StatPearls Publishing Copyright \u0026copy; 2024, StatPearls Publishing LLC.; 2024.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu X, Liao Q. A nationwide study of pathogenic microorganisms and treatment options for pelvic inflammatory diseases. In: \u003cem\u003eProceedings of the first National Academic Conference on the progress of female reproductive tract infection research of Chinese Medical Association\u003c/em\u003e: 2008; 2008.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePrice MJ, Ades AE, Soldan K, Welton NJ, Macleod J, Simms I, DeAngelis D, Turner KM, Horner PJ. The natural history of Chlamydia trachomatis infection in women: a multi-parameter evidence synthesis. Health Technol Assess. 2016;20:1\u0026ndash;250.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBrunham RC, Gottlieb SL, Paavonen J. Pelvic inflammatory disease. N Engl J Med. 2015;372:2039\u0026ndash;48.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMikamo H, Iwasaku K, Yamagishi Y, Matsumizu M, Nagashima M. Efficacy and safety of intravenous azithromycin followed by oral azithromycin for the treatment of acute pelvic inflammatory disease and perihepatitis in Japanese women. J Infect Chemother. 2014;20:429\u0026ndash;35.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHan T, Nolan SM, Regard M. Mycoplasma genitalium as a cause of pelvic inflammatory disease. J Pediatr Adolesc Gynecol. 2020;33:739\u0026ndash;41.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePelvic Inflammatory Disease (PID.) [\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.cdc.gov/std/treatment-guidelines/pid.htm]\u003c/span\u003e\u003cspan address=\"https://www.cdc.gov/std/treatment-guidelines/pid.htm]\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePrevention CfDCa: Sexually Transmitted Diseases Treatment Guideline, 2021. Morbidity and Mortality Weekly Report. 2021, 70:94\u0026thinsp;\u0026ndash;\u0026thinsp;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRoss J, Guaschino S, Cusini M, Jensen J. 2017 European guideline for the management of pelvic inflammatory disease. Int J STD AIDS. 2018;29:108\u0026ndash;14.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSobel R, Sobel JD. Metronidazole for the treatment of vaginal infections. Expert Opin Pharmacother. 2015;16:1109\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAlshame HA, Albarrak SK, Alharthy BT, Alayafi YH, Almansour RA, Nooh MI, Nouh YI, Alhendi RSA, Nouh MI, Karrar HR. Metronidazole-induced Metallic Taste: A Systematic Review and Meta-Analysis. J Pharm Res Int. 2021:307\u0026ndash;17.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWiesenfeld HC, Meyn LA, Darville T, Macio IS, Hillier SL. A Randomized Controlled Trial of Ceftriaxone and Doxycycline, With or Without Metronidazole, for the Treatment of Acute Pelvic Inflammatory Disease. Clin Infect Dis. 2021;72:1181\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDean G, Soni S, Pitt R, Ross J, Sabin C, Whetham J. Treatment of mild-to-moderate pelvic inflammatory disease with a short-course azithromycin-based regimen versus ofloxacin plus metronidazole: results of a multicentre, randomised controlled trial. Sex Transm Infect. 2021;97:177\u0026ndash;82.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVerdon R. [Treatment of uncomplicated pelvic inflammatory disease: CNGOF and SPILF Pelvic Inflammatory Diseases Guidelines]. Gynecol Obstet Fertil Senol. 2019;47:418\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYanyan W, Yanqiu H, Sufang G, Fuquan, Junrui W. Distribution characteristics of anaerobes and drug resistance of Bacteroides fragilis in clinical infection specimens. Chin Med J. 2018;98:5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMa L, Zhang Y-Z, Zheng Y-L, Wang Z-H, Xu Y, Kong L. Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections. Zhonghua fu Chan ke za zhi. 2010, 45:754\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHekun M, Jin W, Rui W, Nan B, Beibei L, Jiang C, Mingjing T, Ke W, Xue Wei J, Hui N. Pharmacokinetic study of levamisole in Chinese healthy subjects. In: \u003cem\u003eProceedings of the 13th National Symposium on chemo pharmacology of the Chinese Pharmacological Society\u003c/em\u003e: 2016; 2016.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang X, Wang S, Hu C, Chen W, Shen Y, Wu X, Sun Y, Xu Q. A new pharmacological effect of levornidazole: Inhibition of NLRP3 inflammasome activation. Biochem Pharmacol. 2015;97:178\u0026ndash;88.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHillier SL, Bernstein KT, Aral S. A Review of the Challenges and Complexities in the Diagnosis, Etiology, Epidemiology, and Pathogenesis of Pelvic Inflammatory Disease. J Infect Dis. 2021;224:S23\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu ZH, Jin Z, Zhao H, Lu Y, Zhen H, Zou T. Effect and Safety of Kangfuyan Capsules () for Relieving Chronic Pelvic Pain: A Multicenter, Randomized, Controlled, Double-Blind, Parallel-Group Clinical Trial. Chin J Integr Med. 2021;27:883\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTaylor BD, Darville T, Ferrell RE, Ness RB, Kelsey SF, Haggerty CL. Cross-sectional analysis of Toll-like receptor variants and bacterial vaginosis in African-American women with pelvic inflammatory disease. Sex Transm Infect. 2014;90:563\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eInc. HPU. METRONIDAZOLE REDI-INFUSION. In., 2021.10 edn. accessdata.fda.gov; 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhao Q, Li-Li LI, Pei HU, Zhong W, Ding F, Jia ST, Zheng-Fang HU, Liu WB, Jiang J. Pharmacokinetics of levornidazole disodium phosphate in monkey. Acta Pharm Sinica. 2018.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCao J, Chen Q, Mei HK, Bai N, Jiang XW, Wang J, Wang R. Phase Ⅰ Clinical Trial on Safety and Tolerability of Levornidazole Disodium Phosphate for Injection in Chinese Healthy Volunteers. Chinese Journal of Pharmacovigilance.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"pelvic inflammatory disease, levornidazole disodium phosphate, multicenter, randomized controlled, double-blind","lastPublishedDoi":"10.21203/rs.3.rs-4667264/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4667264/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eIn this multicenter, double-blind, randomized, parallel-group study, the efficacy and safety of levornidazole and levornidazole disodium phosphate for the treatment of women with pelvic inflammatory disease (PID) were compared.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe women from 12 hospitals in China received a 14-day course of intravenous levornidazole at 0.5 g twice a day (Group A, n\u0026thinsp;=\u0026thinsp;49) or intravenous levornidazole disodium phosphate at 1.0 g once a day (Group B, n\u0026thinsp;=\u0026thinsp;49) or 0.5 g twice a day (Group C, n\u0026thinsp;=\u0026thinsp;46).\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOverall, of the 144 patients in the full analysis set (FAS), 91.00% (n\u0026thinsp;=\u0026thinsp;131) were included in the per-protocol set; further, 38 of these cases (29.00%) were microbiologically valid. In the FAS population, the 14-day clinical cure rates were 77.55% for Group A, 83.67% for Group B, and 82.61% for Group C (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.7446). The 14-day bacteriological clearance rates in the FAS population were 76.47% for Group A, 93.75% for Group B, and 100.00% for Group C (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.2476). Drug-related adverse events occurred less frequently in Group B (38.78%) than in Group A (61.22%; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.025).\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThese results indicate that daily administration of levornidazole disodium phosphate as a concentration-dependent antibacterial agent antibacterial agent for 14 days was as clinically and bacteriologically efficacious for women with PID as levornidazole twice daily for 14 days. Moreover, the former was associated with significantly fewer drug-related adverse events.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eChiCTR2300073123 registered on 03/07/2023 (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.chictr.org.cn/showproj.html?proj=196700\u003c/span\u003e\u003cspan address=\"https://www.chictr.org.cn/showproj.html?proj=196700\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e).\u003c/p\u003e","manuscriptTitle":"Efficacy and safety of levornidazole disodium phosphate for the treatment of pelvic inflammatory disease: A multicenter, double-blind, randomized trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-26 17:11:33","doi":"10.21203/rs.3.rs-4667264/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d6b306f3-023c-4a0b-80b9-ed34be8e6e43","owner":[],"postedDate":"July 26th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-30T09:44:38+00:00","versionOfRecord":[],"versionCreatedAt":"2024-07-26 17:11:33","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4667264","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4667264","identity":"rs-4667264","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}