Clinical application of a 10-day vonoprazan and minocycline-containing quadruple regimen for Helicobacter pylori rescue therapy

Clinical application of a 10-day vonoprazan and minocycline-containing quadruple regimen for Helicobacter pylori rescue therapy | 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 Article Clinical application of a 10-day vonoprazan and minocycline-containing quadruple regimen for Helicobacter pylori rescue therapy Xiangchen Qiu, Qiao Wang, Haoran Ma, Fuqiang Zu, Ruyu Li, Yuting Heng This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9429094/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Objective: To evaluate the eradication efficacy of a quadruple regimen combining vonoprazan, amoxicillin, minocycline, and bismuth in patients requiring rescue therapy for Helicobacter pylori (H. pylori) infection, and to compare the differences in eradication rates and safety between 10-day and 14-day treatment durations. Methods: This study used a single-center, prospective, non-randomized interventional design. Patients were assigned to either a 10-day or a 14-day treatment group. The primary outcome was the result of the urea breath test (UBT) performed one month after treatment completion, and eradication rates were calculated using intention-to-treat (ITT), modified intention-to-treat (mITT), and per-protocol(PP) analyses. Adverse drug reactions were recorded, and the incremental cost-effectiveness ratio (ICER) was calculated. Results: In the comparison of different treatment durations for the vonoprazan and minocycline-containing regimen, the ITT eradication rates for the 10-day and 14-day rescue therapy groups were 81.63% and 85.25%, respectively ( p = 0.611). The mITT eradication rates were 95.24% (40/42) and 96.30% (52/54), and the PP eradication rates were 95.12% (39/41) and 96.15% (50/52), with no statistically significant differences ( p = 1.000). Regarding safety, the adverse reaction rates in the 10-day and 14-day groups were 20.83% and 26.67%, respectively ( p = 0.484). In the economic evaluation, the ICER of the 14-day regimen compared with the 10-day regimen in the PP population was 11,548.83. Conclusions: 1.The vonoprazan-minocycline-bismuth quadruple regimen demonstrates high clinical value and represents an optimal strategy for H. pylori rescue therapy. 2.For the vonoprazan-minocycline regimen, the 10-day and 14-day treatment durations provide comparable eradication efficacy. Furthermore, the 10-day regimen shows a lower incidence of adverse reactions and more significant pharmacoeconomic advantages, supporting its use as the preferred clinical duration. Health sciences/Diseases Biological sciences/Drug discovery Health sciences/Gastroenterology Health sciences/Medical research Biological sciences/Microbiology Vonoprazan Minocycline Helicobacter pylori Bismuth-containing quadruple therapy Pharmacoeconomics Figures Figure 1 Figure 2 Introduction Helicobacter pylori (H. pylori) infection is one of the most prevalent chronic bacterial infections worldwide. It is closely associated with various upper gastrointestinal diseases, including chronic active gastritis, peptic ulcer disease, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and gastric cancer 1 . The World Health Organization (WHO) has classified H. pylori as a Group I carcinogen. Therefore, the successful eradication of H. pylori is crucial for improving patient prognosis and reducing the risk of gastric cancer 2 . In China, H. pylori infection is characterized by high prevalence, strong pathogenicity, high antibiotic resistance, and low eradication rates, posing continuous pressure on public health and clinical management 3 . Particularly in the rescue therapy population, rising resistance to conventional antibiotics—such as clarithromycin, metronidazole, and levofloxacin—has led to increased eradication failure rates 4 . Repeated treatment failures not only increase economic costs and psychological burdens for patients but may also fail to prevent the progression of underlying diseases. Therefore, developing and evaluating highly effective antibiotic regimens with low resistance rates is essential for improving the success rate of H. pylori rescue therapy. Vonoprazan, a novel potassium-competitive acid blocker (P-CAB), provides potent and sustained acid inhibition; meanwhile, minocycline is an antibiotic characterized by low resistance rates in H. pylori. Their combination may offer a new therapeutic option for patients requiring rescue therapy. However, the optimal treatment duration for this regimen has not yet been established. This study employed a prospective, non-randomized interventional design to compare the eradication rates, safety, and adherence of vonoprazan-minocycline-bismuth quadruple therapy between 10-day and 14-day durations, aiming to optimize clinical treatment choices. Materials and Methods 1.1 Study population This study was a single-center, prospective, non-randomized interventional study. Patients with H. pylori infection requiring rescue therapy who visited the Gastroenterology Outpatient Clinic of our hospital between July 2023 and June 2025 were consecutively enrolled. 1.2 Diagnostic and Inclusion/Exclusion Criteria (1) Diagnostic criteria: H. pylori infection was diagnosed if at least one of the following criteria was met: 1) a positive 13 C or 14 C urea breath test (UBT); 2) a positive result from any of the following: rapid urease test (RUT), histological staining, or bacterial culture. (2) Inclusion criteria: 1) met the aforementioned diagnostic criteria for H. pylori and had failed previous treatment with a Chinese guideline-recommended standard bismuth-containing quadruple therapy (BQT), consisting of a proton pump inhibitor (PPI), bismuth, and two antibiotics (excluding minocycline); 2) aged between 18 and 80 years; 3) ability to understand the study protocols and voluntary provision of written informed consent. (3) Exclusion criteria: 1) inability to comply with treatment or follow-up procedures; 2) presence of psychiatric disorders or severe dysfunction of vital organs (e.g., heart, liver, or kidney) before enrollment; 3) women who were pregnant, lactating, or planning to become pregnant; 4) known history of allergy to any components of the drugs used in this study; 5) use of bismuth or other antibiotics within 4 weeks prior to treatment, or use of PPIs or H2-receptor antagonists (H2RAs) within 2 weeks prior to treatment; 6) history of upper gastrointestinal surgery.This study was conducted in accordance with the principles of the Declaration of Helsinki. All patients provided written informed consent after being fully informed. The study protocol was approved by the Ethics Committee of our hospital (Ethics Approval No.: YX2023-146). 1.3 Study Grouping and Treatment Regimens This study population consisted of patients with previous H. pylori eradication failure requiring rescue therapy. A prospective, non-randomized interventional study design was adopted. All enrolled patients received a quadruple regimen consisting of vonoprazan, bismuth pectin, amoxicillin, and minocycline. Patients were assigned to either a 10-day or a 14-day regimen group. All patients underwent a 13 C or 14 C urea breath test (UBT) after fasting for one month following treatment cessation to evaluate efficacy. Treatment-related adverse drug reactions (ADRs) during the therapy were recorded via questionnaires. Eradication success was defined as a negative UBT result one month after the end of treatment. The differences in H. pylori eradication rates, safety, and patient adherence were compared between the 10-day and 14-day regimens. The medications used in the study included: vonoprazan fumarate tablets (20 mg/tablet; Takeda Pharmaceutical Co., Ltd.; Grant No. J20200011), administered as 20 mg twice daily (b.i.d.), 30 min before meals; colloidal bismuth pectin capsules (100 mg/capsule; Shanxi Zhendong Anxin Biopharmaceutical Co., Ltd.; Grant No. H20058476), administered as 200 mg b.i.d., 30 min before meals; amoxicillin capsules (0.5 g/capsule; North China Pharmaceutical Co., Ltd.; Grant No. H20043535), administered as 1.0 g b.i.d., 30 min after meals; and minocycline hydrochloride capsules (100 mg/capsule; Hanhui Pharmaceuticals Co., Ltd.; Grant No. H20174081), administered as 100 mg b.i.d., 30 min after meals. 1.4 Medication Guidance and Precautions The researchers provided standardized medication guidance to all enrolled patients and emphasized the following precautions: (1) Monitoring and management of adverse drug reactions (ADRs): Patients were informed that mild-to-moderate reactions, such as melena, abdominal distension, diarrhea, nausea, constipation, and a bitter taste, might occur during treatment. These reactions were generally tolerable and did not require treatment discontinuation. However, in the event of intolerable or suspected allergic symptoms—such as significant dizziness, severe gastrointestinal distress, rash, or dyspnea—patients were instructed to stop the medication immediately and contact the researchers or seek medical attention. (2) Dietary and lifestyle management: Patients were required to strictly abstain from alcohol and reduce the intake of spicy or irritating foods to minimize the risk of gastric mucosal injury. Additionally, a split-meal system was implemented to block cross-infection. (3) Timing and administration protocols: Colloidal bismuth pectin, vonoprazan, or rabeprazole had to be taken before meals to ensure optimal acid suppression and gastric protection. Amoxicillin, clarithromycin, or minocycline were recommended to be taken after meals. Specifically, clarithromycin extended-release tablets had to be swallowed whole and must not be crushed or chewed to maintain their extended-release characteristics and therapeutic stability. 1.5 Data Collection General data collected included patient name, sex, age, history of upper gastrointestinal endoscopy, and primary gastrointestinal symptoms prior to the current treatment. For patients undergoing rescue therapy, the number of previous H. pylori eradication failures and the types of prior regimens used were also recorded. During the study, treatment-related adverse drug reactions and medication adherence were systematically collected. Data were sourced from the hospital's electronic medical record (EMR) system and records of examinations and treatments from other medical institutions provided by patients. Supplemental information was obtained through face-to-face interviews during outpatient or follow-up visits, as well as via telephone or WeChat follow-ups. Adherence assessment was primarily based on patient-reported actual treatment duration, the number of missed doses, and the count of remaining medications. Good adherence was defined as the consumption of at least 80% of the planned dosage. 1.6 Outcome Measures and Definitions Primary outcome (H. pylori eradication rate): After completing the 10-day or 14-day regimen, patients discontinued antibiotics and bismuth for at least 4 weeks and stopped vonoprazan or other acid-suppressing drugs for at least 2 weeks. A 13 C or 14 C UBT was then performed to evaluate the treatment efficacy. Eradication success was defined as a negative UBT result, whereas a positive result was defined as eradication failure. Secondary outcome (Adverse reactions): Observed gastrointestinal symptoms included nausea, vomiting, diarrhea, abdominal pain, abdominal distension, constipation, and melena. Systemic or neuropsychiatric symptoms, such as dysgeusia, bitter taste, dizziness, fatigue, insomnia, rash, and palpitations, were also recorded. Serious adverse events (SAEs) requiring hospitalization or leading to premature treatment discontinuation were documented separately, with detailed records of the event progression and management outcomes. Data on adverse reactions were primarily sourced from spontaneous patient reports during the treatment and telephone or WeChat follow-ups after the therapy. 1.7 Economic Evaluation The costs in this study only included direct medication costs related to the regimens, which were calculated based on the actual purchase prices or the prices per full package. Other expenses, such as outpatient visits, examinations, follow-up urea breath tests, transportation, and indirect costs related to work absence, were excluded. A cost-effectiveness analysis was performed using the successful eradication of one H. pylori infection as the effectiveness measure, and the incremental cost-effectiveness ratio (ICER) was calculated. 1.8 Statistical Analysis Statistical analyses were performed using SPSS version 27.0, and figures were generated using GraphPad Prism version 8.0.All statistical tests were two-sided. Continuous variables were first subjected to normality tests and tests for homogeneity of variance. Quantitative data following a normal distribution with homogeneous variance were expressed as mean ± standard deviation (SD), and comparisons between two groups were performed using the independent samples t-test. Categorical data were expressed as frequencies and percentages, and intergroup comparisons were performed using the Chi-square test based on the expected frequencies. Fisher's exact test was used when any expected frequency was small (eg. < 5). A p -value < 0.05 was considered statistically significant. Results 2.1 Patient enrollment and baseline characteristics A total of 122 patients with H. pylori infection requiring rescue therapy who visited the Gastroenterology Department of our hospital between July 2023 and June 2025 were screened. Based on the established inclusion and exclusion criteria, 12 patients were excluded: 11 refused participation and chose alternative regimens, and 1 was excluded due to pregnancy planning. Finally, 110 patients were included in the intention-to-treat (ITT) analysis, with 49 in the 10-day regimen group and 61 in the 14-day regimen group (Fig. 1 ).During the follow-up period, 6 patients in the 14-day group did not undergo re-examination as planned, and 1 was lost to follow-up. In the 10-day group, 5 patients did not undergo re-examination, 1 discontinued treatment early due to adverse reactions or poor adherence and did not undergo re-examination, and 1 did not take the medication. Based on the actual medication and re-examination status, 96 patients were included in the modified intention-to-treat (mITT) analysis (42 in the 10-day group and 54 in the 14-day group). After further excluding 1 patient who did not strictly follow the protocol and 1 who discontinued treatment prematurely but completed the re-examination, a total of 93 patients were included in the per-protocol (PP) analysis (41 in the 10-day group and 52 in the 14-day group).The baseline characteristics of the two groups are shown in Table 1 . No statistically significant differences were observed between the two groups in age (42.73 ± 13.51 years vs 42.59 ± 13.33 years, p = 0.957) or sex distribution (proportion of males: 40.82% vs 37.70%, p = 0.74). Regarding treatment history, initial eradication failure predominated in both groups (83.67% vs 80.33%), and no significant difference was found in the distribution of previous failure frequencies ( p = 0.651). Table 1 Comparison of baseline characteristics between the two treatment groups in previously treated patients Characteristics 10-day regimen group(n = 49) 14-day regimen group(n = 61) t / χ² p Age(years, \(\:\overline{x}\) ±s) 42.73 ± 13.51 42.59 ± 13.33 0.054 0.957 Sex, n(%) 0.110 0.74 Male 20(40.82%) 23(37.70%) Female 29(59.18%) 38(62.30%) Previous eradication failures, n(%) 0.204 0.651 1 time 41(83.67%) 49(80.33%) ≥ 2 times 8(16.33%) 12(19.67%) Note: Continuous data are expressed as mean±standard deviation (SD) and compared using the independent-samples t-test. Categorical data are expressed as number (percentage) and compared using the Chi-square test. 2.2 Comparison of baseline endoscopic characteristics between the two groups Among the included subjects, the baseline endoscopic findings of the two groups are presented in Table 2 . No statistically significant differences were observed between the two groups in the distribution of gastritis types ( p = 0.428), the incidence of gastric mucosal erosion (38.46% vs. 17.24%, p = 0.078), or the proportion of bile reflux ( p = 0.131). Additionally, no statistically significant differences were found in the distribution of less common endoscopic features—such as reflux esophagitis, peptic ulcer disease (gastric ulcer, duodenitis, and duodenal ulcer), and nodular/chicken-skin-like gastritis—between the two groups (all p > 0.05). Table 2 Comparison of baseline endoscopic findings between the two groups in previously treated patients Endoscopic findings 10-day regimen group(n = 26) 14-day regimen group(n = 29) χ² p Reflux esophagitis, n 2 2 — 1.000ᵃ Gastritis type, n 0.086 0.769 Chronic non-atrophic gastritis 18 19 Chronic atrophic gastritis 8 10 Specific endoscopic features, n Gastric mucosal erosion 10 5 3.112 0.078 Bile reflux 6 2 — 0.131ᵃ Nodular/Chicken-skin-like gastritis 0 1 — 1.000ᵃ Peptic ulcer disease, n Gastric ulcer 2 0 — 0.219ᵃ Duodenitis 0 1 — 1.000ᵃ Duodenal ulcer 3 3 — 1.000ᵃ Notes: Data are expressed as number of cases (n). a Fisher's exact test was used due to small expected frequencies (expected count < 5); therefore, the χ² value is not reported. * p < 0.05 indicates statistical significance. 2.3 Comparison of pre-treatment clinical symptoms between the two groups The baseline clinical symptoms before treatment for both groups are presented in Table 3 . No statistically significant differences were observed between the two groups in the general status or the incidence of most gastrointestinal symptoms, such as belching, nausea, abdominal distension, epigastric pain, acid regurgitation, and heartburn (all p > 0.05). However, the proportion of patients reporting a bitter taste or halitosis was significantly higher in the 14-day group than in the 10-day group (19.67% vs. 6.12%, χ² = 4.236, p = 0.040). The 10-day group showed a higher incidence of pharyngeal paresthesia compared to the 14-day group (10.20% vs. 0.0%, Fisher’s exact test, p = 0.016). Table 3 Comparison of baseline clinical symptoms between the two groups before treatment in previously treated patients Clinical Symptoms 10-day regimen group(n = 49) 14-day regimen group(n = 61) χ² p General status, n(%) Asymptomatic 19(38.78%) 24(39.34%) 0.004 0.952 Gastric and epigastric symptoms, n(%) Belching 10(20.41%) 15(24.59%) 0.271 0.603 Hiccups 0(0.00%) 2(3.28%) — 0.501ᵃ Nausea 2(4.08%) 8(13.11%) — 0.180ᵃ Vomiting 1(2.04%) 3(4.92%) — 0.627ᵃ Abdominal distension 12(24.49%) 13(21.31%) 0.156 0.693 Epigastric pain 8(16.33%) 12(19.67%) 0.204 0.651 Anorexia/Poor appetite 1(2.04%) 5(8.20%) — 0.223ᵃ Early satiety 2(4.08%) 9(14.75%) — 0.107ᵃ Epigastric discomfort/Obstruction 6(12.24%) 7(11.48%) 0.015 0.901 Abdominal burning sensation 1(2.04%) 1(1.64%) — 1.000ᵃ Reflux-related symptoms, n(%) Acid regurgitation 8(16.33%) 8(13.11%) 0.226 0.635 Heartburn 1(2.04%) 7(11.48%) — 0.073ᵃ Pharyngeal paresthesia 5(10.20%) 0(0.00%) — 0.016*ᵃ Back/Retrosternal discomfort 5(10.20%) 2(3.28%) — 0.238ᵃ Oral and gustatory symptoms, n(%) Bitter taste/Halitosis 3(6.12%) 12(19.67%) 4.236 0.040* Lower GI and bowel habits, n(%) Constipation/Dry stool 1(2.04%) 5(8.20%) — 0.223ᵃ Diarrhea/Loose stool 2(4.08%) 5(8.20%) — 0.458ᵃ Excessive flatulence 0(0.00%) 1(1.64%) — 1.000ᵃ Notes: Data are expressed as number (percentage), n (%). As patients could report multiple symptoms, the sum of individual counts may exceed the total number of patients. a Fisher's exact test was used due to small expected frequencies (expected count < 5); therefore, the χ² value is not reported. * P < 0.05 indicates statistical significance. 2.4 Comparison of H. pylori eradication rates between the two rescue therapy groups The eradication efficacy of the 10-day and 14-day regimens against H. pylori in rescue therapy patients was evaluated using ITT, mITT, and PP analysis sets; results are shown in Table 4 and Fig. 2 . In the ITT analysis, the eradication rates were 81.63% in the 10-day group and 85.25% in the 14-day group. The 14-day regimen showed a 3.61% increase in the eradication rate compared to the 10-day regimen, but this difference was not statistically significant (χ² = 0.259, p = 0.611). In the mITT analysis, the eradication rates for the two groups were 95.24% and 96.30%, respectively, with a non-significant difference of 1.06% (Fisher’s exact test, p = 1.000). In the PP analysis, the eradication rates in the 10-day and 14-day groups were 95.12% and 96.15%, respectively; the 1.03% difference between the groups was not statistically significant (Fisher’s exact test, p = 1.000). Among rescue therapy patients with good adherence, no statistically significant difference was observed in the eradication rates between the 10-day and 14-day regimens. Table 4 Comparison of H. pylori eradication rates between the two groups Analysis sets 10-day regimen group, n(%) 14-day regimen group, n(%) Rate difference (95%CI) χ² p ITT (n = 49) (n = 61) Success 40(81.63%) 52(85.25%) 3.61%(-15.75%~23.40%) 0.259 0.611 Failure 9(18.37%) 9(14.75%) mITT (n = 42) (n = 54) Success 40(95.24%) 52(96.30%) 1.06%(-11.22%~14.77%) — 1.000ᵃ Failure 2(4.76%) 2(3.70%) PP (n = 41) (n = 52) Success 39(95.12%) 50(96.15%) 1.03%(-11.63%~15.08%) — 1.000ᵃ Failure 2(4.88%) 2(3.85%) Notes: ITT, intention-to-treat; mITT, modified intention-to-treat; PP, per-protocol; CI, confidence interval. a Fisher's exact test was used due to small expected frequencies (expected count < 5); therefore, the χ² value is not reported. Eradication rate difference = (Eradication rate of 14-day regimen) − (Eradication rate of 10-day regimen). 2.5 Comparison of treatment-related adverse drug reactions between the two rescue therapy groups Adverse drug reactions (ADRs) observed during the treatment period for both groups are summarized in Table 5 . The safety set (SS) included 108 patients, with 48 in the 10-day regimen group and 60 in the 14-day regimen group. The overall incidence of ADRs was 20.83% (10/48) in the 10-day group and 26.67% (16/60) in the 14-day group; no statistically significant difference was found between the groups (χ² = 0.489, p = 0.484). Regarding the types of ADRs, gastrointestinal reactions predominated in both groups, including acid regurgitation/belching/heartburn, nausea/vomiting, and abdominal pain/distention. Neurological adverse reactions mainly consisted of dizziness or vertigo.The incidences of abdominal pain/distention (2.08% vs. 10.00%) and increased hunger (0.00% vs. 6.67%) were lower in the 10-day group than in the 14-day group, though Fisher’s exact test showed no statistically significant differences (all p > 0.05). Among other rare ADRs, the 10-day group had one case of palpitations and one case of fungal vaginitis; meanwhile, the 14-day group had two cases of palpitations and one case of nasopharyngitis, with no significant differences between the two groups (all p > 0.05). Additionally, one patient in the 10-day group discontinued treatment due to severe discomfort, including bitter taste, nausea, and abdominal distention. In the 14-day group, one patient stopped medication due to a suspected drug-induced skin rash, and another discontinued due to intolerable extreme dizziness. Table 5 Comparison of treatment-emergent drug-related adverse events during therapy between the two groups Adverse Events 10-day regimen group, n(%) 14-day regimen group, n(%) χ² p Safety set (SS) (n = 48) (n = 60) Total patients with ADRs 10(20.83%) 16(26.67%) 0.489 0.484 Gastrointestinal system Gastrointestinal system 4(8.33%) 7(11.67%) — 0.758ᵃ Nausea/vomiting 4(8.33%) 5(8.33%) — 1.000ᵃ Dysgeusia/bitter taste 2(4.17%) 2(3.33%) — 1.000ᵃ Abdominal pain/distention 1(2.08%) 6(10.00%) — 0.125ᵃ Diarrhea/change in bowel habits 1(2.08%) 2(3.33%) — 1.000ᵃ Constipation 0(0.00%) 3(5.00%) — 0.249ᵃ Decreased appetite/anorexia 0(0.00%) 3(5.00%) — 0.249ᵃ Increased hunger 0(0.00%) 4(6.67%) — 0.124ᵃ Neurological system Dizziness/vertigo 3(6.25%) 7(11.67%) — 0.514ᵃ Insomnia/fatigue 1(2.08%) 4(6.67%) — 0.375ᵃ Headache 0(0.00%) 1(1.67%) — 1.000ᵃ Skin and other Rash/pruritus 0(0.00%) 1(1.67%) — 1.000ᵃ Palpitations/chest tightness 1(2.08%) 2(3.33%) — 1.000ᵃ Nasopharyngitis 0(0.00%) 1(1.67%) — 1.000ᵃ Fungal vaginitis 1(2.08%) 0(0.00%) — 0.444ᵃ Discontinuation due to ADRs 1(2.08%) 2(3.33%) — 1.000ᵃ Notes: Data are expressed as number (percentage), n (%). As a single patient may experience multiple ADRs, the sum of individual cases may exceed the total number of patients with ADRs. a Fisher's exact test was used due to small expected frequencies (expected count < 5); therefore, the χ² value is not reported. 2.6 Cost breakdown and cost-effectiveness analysis of the regimens Cost accounting was performed for the two treatment regimens, with details provided in Table 6 . The cost analysis only included direct medication costs required for the treatment. The total direct medication cost was 307.98 CNY for the 10-day regimen and 427.32 CNY for the 14-day regimen. Compared with the 10-day regimen, the 14-day regimen incurred an additional drug cost of 119.34 CNY due to the increased dosage of medications such as vonoprazan and minocycline resulting from the extended treatment duration. Additionally, cost-effectiveness analyses (CEA) were conducted in the ITT, mITT, and PP analysis sets, and the results are presented in Table 7 . The cost-effectiveness (C/E) ratio was calculated using direct medication costs as the cost index and H. pylori eradication rates as the effectiveness measure. The incremental cost-effectiveness ratio (ICER) was calculated based on the incremental cost (ΔC) and incremental effect (ΔE) of the 14-day regimen relative to the 10-day regimen. In the ITT analysis, the C/E ratios for the 10-day and 14-day regimens were 377.25 and 501.24, respectively. Compared to the 10-day regimen, the 14-day regimen had a ΔC of 119.34 CNY and a ΔE of 0.03615, resulting in an ICER of 3,300.67 CNY. In the ITT population, the incremental cost required to successfully eradicate one additional case of H. pylori using the 14-day regimen was approximately 3,300.67 CNY. In the mITT and PP analyses, the differences in eradication rates between the two groups were smaller (ΔE ≈ 1%), leading to correspondingly higher ICERs: 11,277.74 CNY for mITT and 11,548.83 CNY for PP. Table 6 Cost breakdown of the treatment regimens Medication Specification Unit Price (CNY) 10-day Quantity 10-day Cost (CNY) 14-day Quantity 14-day Cost (CNY) Vonoprazan 20mg*7tablets 69.30 3boxes 207.90 4boxes 277.20 Minocycline 100mg*10capsules 40.28 2boxes 80.56 3boxes 120.84 Amoxicillin 0.5g*24capsules 5.76 2boxes 11.52 3boxes 17.28 Bismuth pectin 100mg*24capsules 4.00 2boxes 8.00 3boxes 12.00 Total drug cost 307.98 427.32 Notes: All medication costs are calculated based on the number of full boxes required for the treatment duration. Unit prices are derived from the current pharmacy pricing at our hospital. The total cost includes only direct medication expenditures and excludes registration fees, consultation fees, and related diagnostic or follow-up testing costs. Table 7 Cost-effectiveness analysis in previously treated patients Analysis Populations n Total Cost per Patient (CNY) Eradication Rate, n(%) C/E ΔC ΔE ICER ITT 10-day regimen 49 307.98 40(81.63%) 377.25 — — — 14-day regimen 61 427.32 52(85.25%) 501.24 119.34 0.03615(3.61%) 3300.67 mITT 10-day regimen 42 307.98 40(95.24%) 323.38 — — — 14-day regimen 54 427.32 52(96.30%) 443.74 119.34 0.01058(1.06%) 11277.74 PP 10-day regimen 41 307.98 39(95.12%) 323.8 — — — 14-day regimen 52 427.32 50(96.15%) 444.41 119.34 0.01033(1.03%) 11548.83 Notes: ITT, intention-to-treat; mITT, modified intention-to-treat; PP, per-protocol; C/E, cost-effectiveness ratio; ΔC, incremental cost; ΔE, incremental effect; ICER, incremental cost-effectiveness ratio. C/E = Total Cost / Eradication Rate. A lower C/E ratio indicates better economic efficiency, meaning fewer resources are required to achieve a unit of therapeutic success. ICER = ΔC / ΔE, where ΔC is the cost difference between the 14-day and 10-day regimens, and ΔE is the difference in eradication rates. ICER represents the additional cost required to achieve one extra successful eradication case by choosing the 14-day regimen over the 10-day regimen. Discussion This single-center, prospective, non-randomized interventional study compared the efficacy and safety of 10-day versus 14-day vonoprazan-minocycline-bismuth quadruple regimens in patients requiring H. pylori rescue therapy. Our results showed that for the vonoprazan-minocycline quadruple regimen in rescue therapy, the ITT, mITT, and PP eradication rates for the 10-day group were 81.63%, 95.24%, and 95.12%, respectively. In the 14-day group, the ITT, mITT, and PP eradication rates were 85.25%, 96.30%, and 96.15%, respectively, with no statistically significant differences observed between the two groups ( p > 0.05). These findings demonstrate that in the rescue therapy population, the vonoprazan-minocycline-based quadruple therapy achieves eradication rates exceeding 95% in both mITT and PP analyses, regardless of whether a 10-day or 14-day duration is used. This indicates that the quadruple regimen provides high eradication rates and significant therapeutic efficacy for patients with refractory H. pylori infection. This study utilized the bismuth-containing quadruple therapy recommended by the Maastricht VI/Florence consensus and achieved a satisfactory H. pylori eradication rate. This success may be attributed to the combination of a novel acid suppressant and specific antibiotics 5 . Vonoprazan is characterized by its rapid onset of action, potent acid suppression, and sustained duration. It increases intragastric pH in the early stages of treatment and maintains elevated pH levels over time. Furthermore, the antibacterial efficacy of amoxicillin against H. pylori is pH-dependent, meaning that a higher intragastric pH facilitates its bactericidal activity 6 . Minocycline is a semi-synthetic tetracycline antibiotic. It primarily inhibits protein synthesis by binding to the 30S ribosomal subunit of bacteria, thereby exerting a broad-spectrum antibacterial effect. Compared with traditional tetracycline, minocycline possesses higher lipophilicity and superior oral bioavailability, leading to more extensive distribution and accumulation within the gastric mucosal tissues. Moreover, it maintains relatively stable activity even in acidic environments 7 . Dual therapies combining novel acid suppressants and minocycline have demonstrated excellent outcomes in several studies. Recent high-quality randomized controlled trials (RCTs) have indicated that vonoprazan-minocycline dual therapy is non-inferior to either bismuth-containing quadruple therapy or vonoprazan-amoxicillin dual therapy. There were no statistically significant differences in either eradication rates or adverse reactions 8,9 . Although endoscopic biopsy-based bacterial culture and drug susceptibility testing (DST) can guide individualized treatment for patients with multiple eradication failures 10 , this strategy is constrained in clinical practice by its invasive nature, stringent laboratory requirements, and inconsistent success rates, which limit its practical accessibility. Consequently, empirical anti-H. pylori therapy remains the primary choice for most patients requiring rescue treatment. Therefore, selecting a combination of effective antibiotics and potent acid suppressants is of paramount importance. To this end, this study utilized a quadruple regimen consisting of vonoprazan, minocycline, amoxicillin, and bismuth pectin. Previous studies have shown that the eradication rates of traditional proton pump inhibitor (PPI)-bismuth quadruple therapy (BQT) in rescue therapy populations typically range from 70% to 85%. Particularly in regions with high resistance to clarithromycin and metronidazole, the failure rate of secondary eradication remains high 11,12 . However, multiple in vitro monitoring studies have indicated that the resistance rate of H. pylori to minocycline is generally below 2% 13,14 . Furthermore, minocycline possesses certain tissue penetration capabilities, which may contribute to improving the success rate of rescue eradication 7,15 . One study found that resistance to clarithromycin and levofloxacin does not compromise the efficacy of minocycline, with rescue eradication rates reaching up to 97.3% 16 . Moreover, several studies suggested that BQT regimens combining minocycline or other tetracyclines with bismuth and a PPI mostly achieved ITT eradication rates between 80% and 90%, with PP rates approaching or exceeding 95% 13,17,18 . In the context of high antibiotic resistance and previous treatment failure, the regimen in this study maintained a high level of eradication efficacy. This strongly underscores the clinical value of the vonoprazan-minocycline-based quadruple regimen for the rescue therapy population. Regarding adverse drug reactions (ADRs), the symptoms reported by rescue therapy patients in both the 10-day and 14-day groups were primarily dizziness (6.25% vs. 11.67%) and mild-to-moderate gastrointestinal reactions. Common manifestations included acid regurgitation/belching/heartburn (8.33% vs. 11.67%), nausea/vomiting (8.33% vs. 8.33%), and abdominal pain/distention (2.08% vs. 10.00%). In most cases, these symptoms gradually resolved after treatment cessation. The incidence of dizziness/vertigo was lower in the 10-day group than in the 14-day group (6.25% vs. 11.67%), suggesting a potential correlation between this ADR and the extended treatment duration or cumulative exposure to minocycline. However, no statistically significant difference was found between the two groups ( p = 0.514). Additionally, one case of fungal vaginitis occurred in the 10-day rescue therapy group, which was likely associated with antibiotic-induced microbial dysbiosis. This highlights the need to monitor for dysbiosis and the risk of secondary infections during clinical antibiotic administration. Minocycline possesses high lipophilicity and can reach significant concentrations in the cerebrospinal fluid, thereby inducing central vestibular symptoms such as dizziness and vertigo. However, these reactions typically subside gradually during the treatment and resolve rapidly upon discontinuation, indicating that they are primarily reversible adverse effects 19 . Patients with a history of motion sickness or recurrent vertigo may exhibit heightened sensitivity in the vestibular center's integration of motion stimuli 20 . For such populations, clinicians should be more cautious in selecting this regimen and strengthen patient education and follow-up during the initial phase of treatment. Early reminders should be provided to avoid driving or performing high-risk operations. Overall, provided that minocycline is used at conventional dosages, the safety of this regimen remains within an acceptable range. Treatment duration is another critical factor influencing H. pylori eradication rates and patient adherence. Traditional views suggest that extending the treatment duration helps improve eradication rates; thus, 14-day regimens are widely recommended 10,21 . However, longer durations may simultaneously increase the risk of adverse reactions and the overall treatment burden. For the vonoprazan-minocycline-bismuth quadruple therapy, no statistically significant difference in eradication rates was found between the 10-day and 14-day regimens ( p > 0.05). In the rescue therapy PP analysis, the ICER reached 11,548.83 CNY. This indicates that for patients with good adherence, the marginal efficacy gain (approximately 1%) from extending the duration to 14 days comes at a substantial economic cost and a higher risk of adverse reactions, suggesting that the 10-day regimen possesses a superior pharmacoeconomic advantage. In summary, for patients with good adherence and reliable follow-up, the 10-day regimen provides an optimal balance between therapeutic efficacy and treatment burden. It also helps reduce total antibiotic exposure and medication expenditures. Nevertheless, for patients with multiple prior treatment failures and significant therapeutic pressure, clinicians may still opt for the 14-day regimen based on experience to mitigate the potential risk of failure due to insufficient duration. Future studies could explore shortening the duration further to 7 days to evaluate its clinical efficacy and feasibility, thereby reducing the public health burden. Additionally, analysis of the patients' baseline conditions prior to treatment revealed no statistically significant differences across various indicators. However, in the comparison of pre-treatment symptoms, certain items exhibited statistical differences. This may be attributed to the relatively small sample size, which is prone to sampling errors, as well as the inherent heterogeneity among the consecutively enrolled patients. Pre-treatment symptoms are inherently subjective and do not represent objective biochemical indicators; thus, substantial variations exist between individuals. Therefore, these statistical differences lack clinical significance. This study has several limitations. First, the single-center, prospective, non-randomized design may limit the findings. Although we followed a strict protocol, the non-randomized nature of the study means that residual confounding and selection bias cannot be entirely ruled out. Second, the proportion of patients lost to follow-up was relatively high. This might have underestimated the eradication rates in the ITT analysis and introduced potential attrition bias. Third, the economic evaluation only accounted for direct medication costs, excluding expenses related to outpatient visits, laboratory tests, and follow-up urea breath tests.Consequently, the ICER results may be conservative and do not fully reflect the total costs from a healthcare system or societal perspective. Fourth, because H. pylori culture and drug-resistance gene testing were not systematically performed, we could not directly correlate resistance genotypes with therapeutic outcomes; thus, inferences were limited to empirical treatment results. Fifth, the follow-up focused on short-term eradication results at one month post-treatment. The lack of 6-month follow-up data limits our ability to assess the risk of recrudescence and long-term recurrence rates. Conclusions 1. The vonoprazan-minocycline-bismuth quadruple regimen exhibits high clinical utility in patients with H. pylori infection and can serve as a preferred strategy for rescue therapy. 2. For the vonoprazan-minocycline-based regimen, the 10-day duration achieves eradication efficacy comparable to that of the 14-day duration. Furthermore, the 10-day regimen is associated with a lower incidence of adverse reactions and a more significant pharmacoeconomic advantage, making it the recommended duration for clinical practice. Declarations Funding The authors declare that no funding was received for this study. Author Contribution X.Q. and Q.W. conceived and designed the study. X.Q., H.M., F.Z., R.L., and Y.H. were responsible for patient recruitment, clinical data collection, and follow-up interviews. X.Q. and H.M. performed the statistical analyses and the pharmacoeconomic evaluation. X.Q. wrote the main manuscript text. Q.W. provided supervision, managed the project, and performed critical revisions of the manuscript. All authors reviewed the manuscript and approved the final version for submission. Data Availability The datasets generated and/or analysed during the current study are not publicly available due to patient privacy and confidentiality but are available from the corresponding author on reasonable request. References Fischbach, W. & Malfertheiner, P. Helicobacter Pylori Infection. Dtsch. Arztebl Int. 115 (25), 429–436. 10.3238/arztebl.2018.0429 (2018). Yan, L. et al. Effect of Helicobacter pylori Eradication on Gastric Cancer Prevention: Updated Report From a Randomized Controlled Trial With 26.5 Years of Follow-up. Gastroenterology 163 (1), 154–162e3. 10.1053/j.gastro.2022.03.039 (2022). Ren, S. et al. Prevalence of Helicobacter pylori infection in China: A systematic review and meta-analysis. J. Gastroenterol. Hepatol. 37 (3), 464–470. 10.1111/jgh.15751 (2022). Zhang, Y. X. et al. Primary antibiotic resistance of Helicobacter pylori strains isolated from patients with dyspeptic symptoms in Beijing: a prospective serial study. World J. Gastroenterol. 21 (9), 2786–2792. 10.3748/wjg.v21.i9.2786 (2015). Malfertheiner, P. et al. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut . Published online August 8, 2022:gutjnl-2022-327745. 10.1136/gutjnl-2022-327745 Wong, N., Reddy, A. & Patel, A. Potassium-Competitive Acid Blockers: Present and Potential Utility in the Armamentarium for Acid Peptic Disorders. Gastroenterol. Hepatol. (N Y) . 18 (12), 693–700 (2022). Asadi, A. et al. Minocycline, focus on mechanisms of resistance, antibacterial activity, and clinical effectiveness: Back to the future. J. Global Antimicrob. Resist. 22 , 161–174. 10.1016/j.jgar.2020.01.022 (2020). Li, M. et al. Vonoprazan-minocycline dual therapy as a first-line treatment of Helicobacter pylori infection compared with empirical bismuth-containing quadruple therapy. Th. Adv. Gastroenterol. 18 , 17562848251366156. 10.1177/17562848251366156 (2025). Gao, W. et al. Exploratory Study on Efficacy and Safety of Minocycline-Based Dual Therapy for Helicobacter pylori Eradication. Pathogens 14 (11), 1121. 10.3390/pathogens14111121 (2025). Zhou, L. et al. 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment. Chin Med. J. (engl) 2022;Publish Ahead of Print. 10.1097/CM9.0000000000002546 Alfaro, E., Sostres, C. & Lanas, A. Diagnosis and Treatment of Helicobacter pylori Infection in Real Practice-New Role of Primary Care Services in Antibiotic Resistance Era. Diagnostics (Basel) . 13 (11), 1918. 10.3390/diagnostics13111918 (2023). Mei, H. et al. Efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori infection: a multicenter, randomized controlled clinical trial. Th. Adv. Gastroenterol. 15 , 17562848221142925. 10.1177/17562848221142925 (2022). Zhou, K. et al. Minocycline in the eradication of Helicobacter pylori infection: A systematic review and meta-analysis. World J. Gastroenterol. 30 (17), 2354–2368. 10.3748/wjg.v30.i17.2354 (2024). Kuo, Y. T. et al. Primary antibiotic resistance in Helicobacter pylori in the Asia-Pacific region: a systematic review and meta-analysis. Lancet Gastroenterol. Hepatol. 2 (10), 707–715. 10.1016/S2468-1253(17)30219-4 (2017). Nista, E. C. et al. Clinical Implications of Helicobacter pylori Antibiotic Resistance in Italy: A Review of the Literature. Antibiot. (basel Switz) . 11 (10), 1452. 10.3390/antibiotics11101452 (2022). Zhou, J. et al. Efficacy and safety of vonoprazan-based bismuth quadruple therapy for first-line Helicobacter pylori eradication: A large-scale, real-world study. Med. (Baltim). 103 (42), e40170. 10.1097/MD.0000000000040170 (2024). Huang, Y. et al. Minocycline vs. tetracycline in bismuth-containing quadruple therapy for Helicobacter pylori rescue treatment: a multicentre, randomized controlled trial. J. Gastroenterol. 58 (7), 633–641. 10.1007/s00535-023-01991-y (2023). Gao, W., Zhu, M., Yin, Y., Zhang, X. & Wang, L. Efficacy and safety of minocycline quadruple therapy for Helicobacter pylori eradication: A meta-analysis of RCTs. Helicobacter 28 (6), e13022. 10.1111/hel.13022 (2023). Elewa, H. F., Hilali, H., Hess, D. C., Machado, L. S. & Fagan, S. C. Minocycline for Acute Neuroprotection. Pharmacotherapy 26 (4), 515–521. 10.1592/phco.26.4.515 (2006). Bertolini, G. & Straumann, D. Moving in a Moving World: A Review on Vestibular Motion Sickness. Front. Neurol. 7 10.3389/fneur.2016.00014 (2016). Kato, M. et al. Guidelines for the management of Helicobacter pylori infection in Japan: 2016 Revised Edition. Helicobacter . Published online May 20, :e12597. (2019). 10.1111/hel.12597 Additional Declarations No competing interests reported. Supplementary Files RawData.xlsx Cite Share Download PDF Status: Under Review Version 1 posted Reviewers invited by journal 30 Apr, 2026 Editor assigned by journal 30 Apr, 2026 Editor invited by journal 21 Apr, 2026 Submission checks completed at journal 18 Apr, 2026 First submitted to journal 18 Apr, 2026 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-9429094","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":625996351,"identity":"59fb7420-782b-4a5c-9cfb-23c56fe95236","order_by":0,"name":"Xiangchen Qiu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAzklEQVRIiWNgGAWjYBACfvb2gw8SDP4zszEzHyBOi2TPmWSDDxXM7HzsbAnEaTG44WAmOeMMM78cP48BkS67wZBszNvGJs3GzPPxxhsGOzndBgI6GGc3HnzM28ZjzMbMu9lyDlC/2QECWphlDoBskUgGatkmzcNwIHEbIS1sEglm0rxtBvVtzDzPiNPCA9QC9H4CMJB52IjTIsEDDuQDQC1sxpZzDIjwi/1xcFQeYJbvP/zwxpsKOzmCWtCsJDZqkLSQqmMUjIJRMApGBAAAe6A72tq9tVsAAAAASUVORK5CYII=","orcid":"","institution":"Second Hospital of Anhui Medical University","correspondingAuthor":true,"prefix":"","firstName":"Xiangchen","middleName":"","lastName":"Qiu","suffix":""},{"id":625996352,"identity":"79d5a544-ca00-4b58-bbaa-7a218be51033","order_by":1,"name":"Qiao Wang","email":"","orcid":"","institution":"Second Hospital of Anhui Medical University","correspondingAuthor":false,"prefix":"","firstName":"Qiao","middleName":"","lastName":"Wang","suffix":""},{"id":625996353,"identity":"983657e1-fe6a-4895-ab67-e91b35fad5de","order_by":2,"name":"Haoran Ma","email":"","orcid":"","institution":"Second Hospital of Anhui Medical University","correspondingAuthor":false,"prefix":"","firstName":"Haoran","middleName":"","lastName":"Ma","suffix":""},{"id":625996354,"identity":"d314adaf-81fb-4923-885a-70990bcaeec0","order_by":3,"name":"Fuqiang Zu","email":"","orcid":"","institution":"Second Hospital of Anhui Medical University","correspondingAuthor":false,"prefix":"","firstName":"Fuqiang","middleName":"","lastName":"Zu","suffix":""},{"id":625996355,"identity":"641dcf1b-8730-4ace-a95e-0e2406fb3fb4","order_by":4,"name":"Ruyu Li","email":"","orcid":"","institution":"Anhui Medical University","correspondingAuthor":false,"prefix":"","firstName":"Ruyu","middleName":"","lastName":"Li","suffix":""},{"id":625996357,"identity":"113c42d9-9e6b-45ff-92ab-c1518a5a1562","order_by":5,"name":"Yuting Heng","email":"","orcid":"","institution":"Second Hospital of Anhui Medical University","correspondingAuthor":false,"prefix":"","firstName":"Yuting","middleName":"","lastName":"Heng","suffix":""}],"badges":[],"createdAt":"2026-04-15 15:41:54","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9429094/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9429094/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":107446885,"identity":"05183c59-7b78-4ae0-8734-6ada1a96c4d2","added_by":"auto","created_at":"2026-04-21 14:53:01","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":238841,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow diagram of participant screening and composition of analysis populations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNote: ITT, intention-to-treat analysis; mITT, modified intention-to-treat analysis; PP, per-protocol analysis.\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-9429094/v1/8217144d9d87431be325ca35.jpeg"},{"id":107446887,"identity":"91860c57-740b-4a7e-a8ce-cd5f3d98c275","added_by":"auto","created_at":"2026-04-21 14:53:01","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":144287,"visible":true,"origin":"","legend":"\u003cp\u003eComparison of \u003cem\u003eH. pylori\u003c/em\u003e eradication rates between the 10-day and 14-day regimens across different analysis sets\u003c/p\u003e\n\u003cp\u003eNote: Yellow bars represent the 10-day regimen group, and blue bars represent the 14-day regimen group. ITT, intention-to-treat population; mITT, modified intention-to-treat population; PP, per-protocol population.\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-9429094/v1/28263018757f9be3e7966b16.jpeg"},{"id":107708481,"identity":"5a0c9af3-0730-4971-8e97-ef40885cc1ca","added_by":"auto","created_at":"2026-04-24 09:27:24","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":964237,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9429094/v1/8d5f047f-15fe-4bf7-b571-05ddcb902d82.pdf"},{"id":107704483,"identity":"76d73361-c116-440a-8b94-b041a64a4132","added_by":"auto","created_at":"2026-04-24 08:45:36","extension":"xlsx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":432434,"visible":true,"origin":"","legend":"","description":"","filename":"RawData.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-9429094/v1/d23290a68c7b12caf8c3c651.xlsx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Clinical application of a 10-day vonoprazan and minocycline-containing quadruple regimen for Helicobacter pylori rescue therapy","fulltext":[{"header":"Introduction","content":"\u003cp\u003eHelicobacter pylori (H. pylori) infection is one of the most prevalent chronic bacterial infections worldwide. It is closely associated with various upper gastrointestinal diseases, including chronic active gastritis, peptic ulcer disease, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and gastric cancer\u003csup\u003e1\u003c/sup\u003e. The World Health Organization (WHO) has classified H. pylori as a Group I carcinogen. Therefore, the successful eradication of H. pylori is crucial for improving patient prognosis and reducing the risk of gastric cancer\u003csup\u003e2\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eIn China, H. pylori infection is characterized by high prevalence, strong pathogenicity, high antibiotic resistance, and low eradication rates, posing continuous pressure on public health and clinical management\u003csup\u003e3\u003c/sup\u003e. Particularly in the rescue therapy population, rising resistance to conventional antibiotics\u0026mdash;such as clarithromycin, metronidazole, and levofloxacin\u0026mdash;has led to increased eradication failure rates\u003csup\u003e4\u003c/sup\u003e. Repeated treatment failures not only increase economic costs and psychological burdens for patients but may also fail to prevent the progression of underlying diseases. Therefore, developing and evaluating highly effective antibiotic regimens with low resistance rates is essential for improving the success rate of H. pylori rescue therapy.\u003c/p\u003e\n\u003cp\u003eVonoprazan, a novel potassium-competitive acid blocker (P-CAB), provides potent and sustained acid inhibition; meanwhile, minocycline is an antibiotic characterized by low resistance rates in H. pylori. Their combination may offer a new therapeutic option for patients requiring rescue therapy. However, the optimal treatment duration for this regimen has not yet been established. This study employed a prospective, non-randomized interventional design to compare the eradication rates, safety, and adherence of vonoprazan-minocycline-bismuth quadruple therapy between 10-day and 14-day durations, aiming to optimize clinical treatment choices.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003e\u003cstrong\u003e1.1 Study population\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was a single-center, prospective, non-randomized interventional study. Patients with H. pylori infection requiring rescue therapy who visited the Gastroenterology Outpatient Clinic of our hospital between July 2023 and June 2025 were consecutively enrolled.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.2 Diagnostic and Inclusion/Exclusion Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(1) Diagnostic criteria: H. pylori infection was diagnosed if at least one of the following criteria was met: 1) a positive \u003csup\u003e13\u003c/sup\u003eC or \u003csup\u003e14\u003c/sup\u003eC urea breath test (UBT); 2) a positive result from any of the following: rapid urease test (RUT), histological staining, or bacterial culture.\u003c/p\u003e\n\u003cp\u003e(2) Inclusion criteria: 1) met the aforementioned diagnostic criteria for H. pylori and had failed previous treatment with a Chinese guideline-recommended standard bismuth-containing quadruple therapy (BQT), consisting of a proton pump inhibitor (PPI), bismuth, and two antibiotics (excluding minocycline); 2) aged between 18 and 80 years; 3) ability to understand the study protocols and voluntary provision of written informed consent.\u003c/p\u003e\n\u003cp\u003e(3) Exclusion criteria: 1) inability to comply with treatment or follow-up procedures; 2) presence of psychiatric disorders or severe dysfunction of vital organs (e.g., heart, liver, or kidney) before enrollment; 3) women who were pregnant, lactating, or planning to become pregnant; 4) known history of allergy to any components of the drugs used in this study; 5) use of bismuth or other antibiotics within 4 weeks prior to treatment, or use of PPIs or H2-receptor antagonists (H2RAs) within 2 weeks prior to treatment; 6) history of upper gastrointestinal surgery.This study was conducted in accordance with the principles of the Declaration of Helsinki. All patients provided written informed consent after being fully informed.\u003c/p\u003e\n\u003cp\u003eThe study protocol was approved by the Ethics Committee of our hospital (Ethics Approval No.: YX2023-146). \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.3 Study Grouping and Treatment Regimens\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study population consisted of patients with previous H. pylori eradication failure requiring rescue therapy. A prospective, non-randomized interventional study design was adopted. All enrolled patients received a quadruple regimen consisting of vonoprazan, bismuth pectin, amoxicillin, and minocycline. Patients were assigned to either a 10-day or a 14-day regimen group. All patients underwent a \u003csup\u003e13\u003c/sup\u003eC or \u003csup\u003e14\u003c/sup\u003eC urea breath test (UBT) after fasting for one month following treatment cessation to evaluate efficacy. Treatment-related adverse drug reactions (ADRs) during the therapy were recorded via questionnaires. Eradication success was defined as a negative UBT result one month after the end of treatment. The differences in H. pylori eradication rates, safety, and patient adherence were compared between the 10-day and 14-day regimens.\u003c/p\u003e\n\u003cp\u003eThe medications used in the study included: vonoprazan fumarate tablets (20 mg/tablet; Takeda Pharmaceutical Co., Ltd.; Grant No. J20200011), administered as 20 mg twice daily (b.i.d.), 30 min before meals; colloidal bismuth pectin capsules (100 mg/capsule; Shanxi Zhendong Anxin Biopharmaceutical Co., Ltd.; Grant No. H20058476), administered as 200 mg b.i.d., 30 min before meals; amoxicillin capsules (0.5 g/capsule; North China Pharmaceutical Co., Ltd.; Grant No. H20043535), administered as 1.0 g b.i.d., 30 min after meals; and minocycline hydrochloride capsules (100 mg/capsule; Hanhui Pharmaceuticals Co., Ltd.; Grant No. H20174081), administered as 100 mg b.i.d., 30 min after meals.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.4 Medication Guidance and Precautions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe researchers provided standardized medication guidance to all enrolled patients and emphasized the following precautions:\u003c/p\u003e\n\u003cp\u003e(1) Monitoring and management of adverse drug reactions (ADRs): Patients were informed that mild-to-moderate reactions, such as melena, abdominal distension, diarrhea, nausea, constipation, and a bitter taste, might occur during treatment. These reactions were generally tolerable and did not require treatment discontinuation. However, in the event of intolerable or suspected allergic symptoms\u0026mdash;such as significant dizziness, severe gastrointestinal distress, rash, or dyspnea\u0026mdash;patients were instructed to stop the medication immediately and contact the researchers or seek medical attention.\u003c/p\u003e\n\u003cp\u003e(2) Dietary and lifestyle management: Patients were required to strictly abstain from alcohol and reduce the intake of spicy or irritating foods to minimize the risk of gastric mucosal injury. Additionally, a split-meal system was implemented to block cross-infection.\u003c/p\u003e\n\u003cp\u003e(3) Timing and administration protocols: Colloidal bismuth pectin, vonoprazan, or rabeprazole had to be taken before meals to ensure optimal acid suppression and gastric protection. Amoxicillin, clarithromycin, or minocycline were recommended to be taken after meals. Specifically, clarithromycin extended-release tablets had to be swallowed whole and must not be crushed or chewed to maintain their extended-release characteristics and therapeutic stability.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.5 Data Collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGeneral data collected included patient name, sex, age, history of upper gastrointestinal endoscopy, and primary gastrointestinal symptoms prior to the current treatment. For patients undergoing rescue therapy, the number of previous H. pylori eradication failures and the types of prior regimens used were also recorded.\u003c/p\u003e\n\u003cp\u003eDuring the study, treatment-related adverse drug reactions and medication adherence were systematically collected. Data were sourced from the hospital\u0026apos;s electronic medical record (EMR) system and records of examinations and treatments from other medical institutions provided by patients. Supplemental information was obtained through face-to-face interviews during outpatient or follow-up visits, as well as via telephone or WeChat follow-ups. Adherence assessment was primarily based on patient-reported actual treatment duration, the number of missed doses, and the count of remaining medications. Good adherence was defined as the consumption of at least 80% of the planned dosage.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.6 Outcome Measures and Definitions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePrimary outcome (H. pylori eradication rate): After completing the 10-day or 14-day regimen, patients discontinued antibiotics and bismuth for at least 4 weeks and stopped vonoprazan or other acid-suppressing drugs for at least 2 weeks. A \u003csup\u003e13\u003c/sup\u003eC or \u003csup\u003e14\u003c/sup\u003eC UBT was then performed to evaluate the treatment efficacy. Eradication success was defined as a negative UBT result, whereas a positive result was defined as eradication failure.\u003c/p\u003e\n\u003cp\u003eSecondary outcome (Adverse reactions): Observed gastrointestinal symptoms included nausea, vomiting, diarrhea, abdominal pain, abdominal distension, constipation, and melena. Systemic or neuropsychiatric symptoms, such as dysgeusia, bitter taste, dizziness, fatigue, insomnia, rash, and palpitations, were also recorded. Serious adverse events (SAEs) requiring hospitalization or leading to premature treatment discontinuation were documented separately, with detailed records of the event progression and management outcomes. Data on adverse reactions were primarily sourced from spontaneous patient reports during the treatment and telephone or WeChat follow-ups after the therapy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.7 Economic Evaluation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe costs in this study only included direct medication costs related to the regimens, which were calculated based on the actual purchase prices or the prices per full package. Other expenses, such as outpatient visits, examinations, follow-up urea breath tests, transportation, and indirect costs related to work absence, were excluded. A cost-effectiveness analysis was performed using the successful eradication of one H. pylori infection as the effectiveness measure, and the incremental cost-effectiveness ratio (ICER) was calculated.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.8 Statistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStatistical analyses were performed using SPSS version 27.0, and figures were generated using GraphPad Prism version 8.0.All statistical tests were two-sided. Continuous variables were first subjected to normality tests and tests for homogeneity of variance. Quantitative data following a normal distribution with homogeneous variance were expressed as mean \u0026plusmn; standard deviation (SD), and comparisons between two groups were performed using the independent samples t-test. Categorical data were expressed as frequencies and percentages, and intergroup comparisons were performed using the Chi-square test based on the expected frequencies. Fisher\u0026apos;s exact test was used when any expected frequency was small (eg. \u0026lt; 5). A \u003cem\u003ep\u003c/em\u003e-value \u0026lt; 0.05 was considered statistically significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003e2.1 Patient enrollment and baseline characteristics\u003c/h2\u003e\u003cp\u003eA total of 122 patients with H. pylori infection requiring rescue therapy who visited the Gastroenterology Department of our hospital between July 2023 and June 2025 were screened. Based on the established inclusion and exclusion criteria, 12 patients were excluded: 11 refused participation and chose alternative regimens, and 1 was excluded due to pregnancy planning. Finally, 110 patients were included in the intention-to-treat (ITT) analysis, with 49 in the 10-day regimen group and 61 in the 14-day regimen group (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).During the follow-up period, 6 patients in the 14-day group did not undergo re-examination as planned, and 1 was lost to follow-up. In the 10-day group, 5 patients did not undergo re-examination, 1 discontinued treatment early due to adverse reactions or poor adherence and did not undergo re-examination, and 1 did not take the medication. Based on the actual medication and re-examination status, 96 patients were included in the modified intention-to-treat (mITT) analysis (42 in the 10-day group and 54 in the 14-day group). After further excluding 1 patient who did not strictly follow the protocol and 1 who discontinued treatment prematurely but completed the re-examination, a total of 93 patients were included in the per-protocol (PP) analysis (41 in the 10-day group and 52 in the 14-day group).The baseline characteristics of the two groups are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. No statistically significant differences were observed between the two groups in age (42.73\u0026thinsp;\u0026plusmn;\u0026thinsp;13.51 years vs 42.59\u0026thinsp;\u0026plusmn;\u0026thinsp;13.33 years, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.957) or sex distribution (proportion of males: 40.82% vs 37.70%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.74). Regarding treatment history, initial eradication failure predominated in both groups (83.67% vs 80.33%), and no significant difference was found in the distribution of previous failure frequencies (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.651).\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\u003eComparison of baseline characteristics between the two treatment groups in previously treated patients\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=\"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 \u003cp\u003eCharacteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10-day regimen group(n\u0026thinsp;=\u0026thinsp;49)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14-day regimen group(n\u0026thinsp;=\u0026thinsp;61)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003et / χ\u0026sup2;\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\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, \u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\:\\overline{x}\\)\u003c/span\u003e\u003c/span\u003e\u0026plusmn;s)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e42.73\u0026thinsp;\u0026plusmn;\u0026thinsp;13.51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e42.59\u0026thinsp;\u0026plusmn;\u0026thinsp;13.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.054\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.957\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.110\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.74\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20(40.82%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23(37.70%)\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29(59.18%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e38(62.30%)\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious eradication failures, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.204\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.651\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1 time\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e41(83.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e49(80.33%)\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;2 times\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8(16.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12(19.67%)\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\"\u003eNote: Continuous data are expressed as mean\u0026plusmn;standard deviation (SD) and compared using the independent-samples t-test. Categorical data are expressed as number (percentage) and compared using the Chi-square test.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003e2.2 Comparison of baseline endoscopic characteristics between the two groups\u003c/h2\u003e\u003cp\u003eAmong the included subjects, the baseline endoscopic findings of the two groups are presented in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. No statistically significant differences were observed between the two groups in the distribution of gastritis types (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.428), the incidence of gastric mucosal erosion (38.46% vs. 17.24%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.078), or the proportion of bile reflux (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.131). Additionally, no statistically significant differences were found in the distribution of less common endoscopic features\u0026mdash;such as reflux esophagitis, peptic ulcer disease (gastric ulcer, duodenitis, and duodenal ulcer), and nodular/chicken-skin-like gastritis\u0026mdash;between the two groups (all \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\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\u003eComparison of baseline endoscopic findings between the two groups in previously treated patients\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=\"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\u003eEndoscopic findings\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10-day regimen group(n\u0026thinsp;=\u0026thinsp;26)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14-day regimen group(n\u0026thinsp;=\u0026thinsp;29)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eχ\u0026sup2;\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReflux esophagitis, n\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGastritis type, n\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.086\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.769\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChronic non-atrophic gastritis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e19\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChronic atrophic gastritis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpecific endoscopic features, n\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGastric mucosal erosion\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.112\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.078\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBile reflux\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.131ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNodular/Chicken-skin-like gastritis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePeptic ulcer disease, n\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGastric ulcer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.219ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuodenitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuodenal ulcer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eNotes: Data are expressed as number of cases (n). \u003csup\u003ea\u003c/sup\u003e Fisher's exact test was used due to small expected frequencies (expected count\u0026thinsp;\u0026lt;\u0026thinsp;5); therefore, the χ\u0026sup2; value is not reported. *\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 indicates statistical significance.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Comparison of pre-treatment clinical symptoms between the two groups\u003c/h2\u003e \u003cp\u003eThe baseline clinical symptoms before treatment for both groups are presented in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. No statistically significant differences were observed between the two groups in the general status or the incidence of most gastrointestinal symptoms, such as belching, nausea, abdominal distension, epigastric pain, acid regurgitation, and heartburn (all \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05). However, the proportion of patients reporting a bitter taste or halitosis was significantly higher in the 14-day group than in the 10-day group (19.67% vs. 6.12%, χ\u0026sup2; = 4.236, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.040). The 10-day group showed a higher incidence of pharyngeal paresthesia compared to the 14-day group (10.20% vs. 0.0%, Fisher\u0026rsquo;s exact test, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.016).\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\u003eComparison of baseline clinical symptoms between the two groups before treatment in previously treated patients\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=\"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\u003eClinical Symptoms\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10-day regimen group(n\u0026thinsp;=\u0026thinsp;49)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14-day regimen group(n\u0026thinsp;=\u0026thinsp;61)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eχ\u0026sup2;\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGeneral status, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAsymptomatic\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\u003e24(39.34%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.004\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.952\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGastric and epigastric symptoms, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBelching\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e10(20.41%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e15(24.59%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.271\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.603\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHiccups\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0(0.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2(3.28%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.501ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNausea\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2(4.08%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8(13.11%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.180ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVomiting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1(2.04%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3(4.92%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.627ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAbdominal distension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e12(24.49%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e13(21.31%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.156\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.693\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEpigastric pain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e8(16.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e12(19.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.204\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.651\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnorexia/Poor appetite\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1(2.04%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5(8.20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.223ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEarly satiety\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2(4.08%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9(14.75%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.107ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEpigastric discomfort/Obstruction\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6(12.24%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7(11.48%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.015\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.901\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAbdominal burning sensation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1(2.04%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1(1.64%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReflux-related symptoms, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAcid regurgitation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e8(16.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8(13.11%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.226\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.635\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHeartburn\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1(2.04%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7(11.48%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.073ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePharyngeal paresthesia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5(10.20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0(0.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0.016*ᵃ\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBack/Retrosternal discomfort\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5(10.20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2(3.28%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.238ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOral and gustatory symptoms, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBitter taste/Halitosis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3(6.12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e12(19.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4.236\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e0.040*\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLower GI and bowel habits, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConstipation/Dry stool\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1(2.04%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5(8.20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.223ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiarrhea/Loose stool\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2(4.08%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5(8.20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.458ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExcessive flatulence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0(0.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1(1.64%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eNotes: Data are expressed as number (percentage), n (%). As patients could report multiple symptoms, the sum of individual counts may exceed the total number of patients. \u003csup\u003ea\u003c/sup\u003e Fisher's exact test was used due to small expected frequencies (expected count\u0026thinsp;\u0026lt;\u0026thinsp;5); therefore, the χ\u0026sup2; value is not reported. *\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 indicates statistical significance.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003e2.4 Comparison of H. pylori eradication rates between the two rescue therapy groups\u003c/h2\u003e\u003cp\u003eThe eradication efficacy of the 10-day and 14-day regimens against H. pylori in rescue therapy patients was evaluated using ITT, mITT, and PP analysis sets; results are shown in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e and Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. In the ITT analysis, the eradication rates were 81.63% in the 10-day group and 85.25% in the 14-day group. The 14-day regimen showed a 3.61% increase in the eradication rate compared to the 10-day regimen, but this difference was not statistically significant (χ\u0026sup2; = 0.259, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.611). In the mITT analysis, the eradication rates for the two groups were 95.24% and 96.30%, respectively, with a non-significant difference of 1.06% (Fisher\u0026rsquo;s exact test, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;1.000). In the PP analysis, the eradication rates in the 10-day and 14-day groups were 95.12% and 96.15%, respectively; the 1.03% difference between the groups was not statistically significant (Fisher\u0026rsquo;s exact test, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;1.000). Among rescue therapy patients with good adherence, no statistically significant difference was observed in the eradication rates between the 10-day and 14-day regimens.\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\u003eComparison of H. pylori eradication rates between the two groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\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=\"char\" char=\"\u0026minus;\" 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=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnalysis sets\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10-day regimen group, n(%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14-day regimen group, n(%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eRate difference (95%CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eχ\u0026sup2;\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eITT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;49)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;61)\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 \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuccess\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40(81.63%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e52(85.25%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c4\"\u003e \u003cp\u003e3.61%(-15.75%~23.40%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.259\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.611\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFailure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9(18.37%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9(14.75%)\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 \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003emITT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;42)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;54)\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 \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuccess\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40(95.24%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e52(96.30%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c4\"\u003e \u003cp\u003e1.06%(-11.22%~14.77%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFailure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(4.76%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(3.70%)\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 \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;41)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;52)\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 \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSuccess\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e39(95.12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e50(96.15%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026minus;\" colname=\"c4\"\u003e \u003cp\u003e1.03%(-11.63%~15.08%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFailure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(4.88%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(3.85%)\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 \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eNotes: ITT, intention-to-treat; mITT, modified intention-to-treat; PP, per-protocol; CI, confidence interval. \u003csup\u003ea\u003c/sup\u003e Fisher's exact test was used due to small expected frequencies (expected count\u0026thinsp;\u0026lt;\u0026thinsp;5); therefore, the χ\u0026sup2; value is not reported. Eradication rate difference = (Eradication rate of 14-day regimen) \u0026minus; (Eradication rate of 10-day regimen).\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003e2.5 Comparison of treatment-related adverse drug reactions between the two rescue therapy groups\u003c/h2\u003e\u003cp\u003eAdverse drug reactions (ADRs) observed during the treatment period for both groups are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e. The safety set (SS) included 108 patients, with 48 in the 10-day regimen group and 60 in the 14-day regimen group. The overall incidence of ADRs was 20.83% (10/48) in the 10-day group and 26.67% (16/60) in the 14-day group; no statistically significant difference was found between the groups (χ\u0026sup2; = 0.489, \u003cem\u003ep\u0026thinsp;=\u003c/em\u003e\u0026thinsp;0.484). Regarding the types of ADRs, gastrointestinal reactions predominated in both groups, including acid regurgitation/belching/heartburn, nausea/vomiting, and abdominal pain/distention. Neurological adverse reactions mainly consisted of dizziness or vertigo.The incidences of abdominal pain/distention (2.08% vs. 10.00%) and increased hunger (0.00% vs. 6.67%) were lower in the 10-day group than in the 14-day group, though Fisher\u0026rsquo;s exact test showed no statistically significant differences (all \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Among other rare ADRs, the 10-day group had one case of palpitations and one case of fungal vaginitis; meanwhile, the 14-day group had two cases of palpitations and one case of nasopharyngitis, with no significant differences between the two groups (all \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Additionally, one patient in the 10-day group discontinued treatment due to severe discomfort, including bitter taste, nausea, and abdominal distention. In the 14-day group, one patient stopped medication due to a suspected drug-induced skin rash, and another discontinued due to intolerable extreme dizziness.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \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\u003eComparison of treatment-emergent drug-related adverse events during therapy between the two groups\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\u003eAdverse Events\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10-day regimen group, n(%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14-day regimen group, n(%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eχ\u0026sup2;\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSafety set (SS)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;48)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;60)\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal patients with ADRs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10(20.83%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16(26.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.489\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.484\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGastrointestinal system\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGastrointestinal system\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4(8.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7(11.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.758ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNausea/vomiting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4(8.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5(8.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDysgeusia/bitter taste\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2(4.17%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(3.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAbdominal pain/distention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(2.08%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6(10.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.125ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiarrhea/change in bowel habits\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(2.08%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(3.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConstipation\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\u003e3(5.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.249ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDecreased appetite/anorexia\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\u003e3(5.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.249ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIncreased hunger\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\u003e4(6.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.124ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeurological system\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDizziness/vertigo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3(6.25%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7(11.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.514ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInsomnia/fatigue\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(2.08%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4(6.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.375ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHeadache\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(1.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSkin and other\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\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 \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRash/pruritus\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(1.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePalpitations/chest tightness\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(2.08%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(3.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNasopharyngitis\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(1.67%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFungal vaginitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(2.08%)\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\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.444ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiscontinuation due to ADRs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1(2.08%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2(3.33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.000ᵃ\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eNotes: Data are expressed as number (percentage), n (%). As a single patient may experience multiple ADRs, the sum of individual cases may exceed the total number of patients with ADRs. \u003csup\u003ea\u003c/sup\u003e Fisher's exact test was used due to small expected frequencies (expected count\u0026thinsp;\u0026lt;\u0026thinsp;5); therefore, the χ\u0026sup2; value is not reported.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003e2.6 Cost breakdown and cost-effectiveness analysis of the regimens\u003c/h2\u003e \u003cp\u003eCost accounting was performed for the two treatment regimens, with details provided in Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e6\u003c/span\u003e. The cost analysis only included direct medication costs required for the treatment. The total direct medication cost was 307.98 CNY for the 10-day regimen and 427.32 CNY for the 14-day regimen. Compared with the 10-day regimen, the 14-day regimen incurred an additional drug cost of 119.34 CNY due to the increased dosage of medications such as vonoprazan and minocycline resulting from the extended treatment duration.\u003c/p\u003e\u003cp\u003eAdditionally, cost-effectiveness analyses (CEA) were conducted in the ITT, mITT, and PP analysis sets, and the results are presented in Table\u0026nbsp;\u003cspan refid=\"Tab7\" class=\"InternalRef\"\u003e7\u003c/span\u003e. The cost-effectiveness (C/E) ratio was calculated using direct medication costs as the cost index and H. pylori eradication rates as the effectiveness measure. The incremental cost-effectiveness ratio (ICER) was calculated based on the incremental cost (ΔC) and incremental effect (ΔE) of the 14-day regimen relative to the 10-day regimen. In the ITT analysis, the C/E ratios for the 10-day and 14-day regimens were 377.25 and 501.24, respectively. Compared to the 10-day regimen, the 14-day regimen had a ΔC of 119.34 CNY and a ΔE of 0.03615, resulting in an ICER of 3,300.67 CNY. In the ITT population, the incremental cost required to successfully eradicate one additional case of H. pylori using the 14-day regimen was approximately 3,300.67 CNY. In the mITT and PP analyses, the differences in eradication rates between the two groups were smaller (ΔE\u0026thinsp;\u0026asymp;\u0026thinsp;1%), leading to correspondingly higher ICERs: 11,277.74 CNY for mITT and 11,548.83 CNY for PP.\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\u003eCost breakdown of the treatment regimens\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=\"char\" char=\".\" 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 \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\u003eMedication\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSpecification\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eUnit Price (CNY)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10-day Quantity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10-day Cost (CNY)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14-day Quantity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003e14-day Cost (CNY)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVonoprazan\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20mg*7tablets\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e69.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3boxes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e207.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4boxes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e277.20\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMinocycline\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e100mg*10capsules\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e40.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2boxes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e80.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3boxes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e120.84\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAmoxicillin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.5g*24capsules\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5.76\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2boxes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e11.52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3boxes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e17.28\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBismuth pectin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e100mg*24capsules\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2boxes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e8.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3boxes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e12.00\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal drug cost\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e307.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e427.32\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eNotes: All medication costs are calculated based on the number of full boxes required for the treatment duration. Unit prices are derived from the current pharmacy pricing at our hospital. The total cost includes only direct medication expenditures and excludes registration fees, consultation fees, and related diagnostic or follow-up testing costs.\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=\"Tab7\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 7\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCost-effectiveness analysis in previously treated patients\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=\"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 \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\u003eAnalysis Populations\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003en\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTotal Cost per Patient (CNY)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eEradication Rate, n(%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eC/E\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eΔC\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eΔE\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eICER\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eITT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\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\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10-day regimen\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e307.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e40(81.63%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e377.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e14-day regimen\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e427.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e52(85.25%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e501.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e119.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.03615(3.61%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e3300.67\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003emITT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\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\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10-day regimen\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e307.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e40(95.24%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e323.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e14-day regimen\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e427.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e52(96.30%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e443.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e119.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.01058(1.06%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e11277.74\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\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\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10-day regimen\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e307.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e39(95.12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e323.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u0026mdash;\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e14-day regimen\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e427.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e50(96.15%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e444.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e119.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.01033(1.03%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e11548.83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"8\"\u003eNotes: ITT, intention-to-treat; mITT, modified intention-to-treat; PP, per-protocol; C/E, cost-effectiveness ratio; ΔC, incremental cost; ΔE, incremental effect; ICER, incremental cost-effectiveness ratio. C/E\u0026thinsp;=\u0026thinsp;Total Cost / Eradication Rate. A lower C/E ratio indicates better economic efficiency, meaning fewer resources are required to achieve a unit of therapeutic success. ICER\u0026thinsp;=\u0026thinsp;ΔC / ΔE, where ΔC is the cost difference between the 14-day and 10-day regimens, and ΔE is the difference in eradication rates. ICER represents the additional cost required to achieve one extra successful eradication case by choosing the 14-day regimen over the 10-day regimen.\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\u003eThis single-center, prospective, non-randomized interventional study compared the efficacy and safety of 10-day versus 14-day vonoprazan-minocycline-bismuth quadruple regimens in patients requiring \u003cem\u003eH. pylori\u003c/em\u003e rescue therapy.\u003c/p\u003e\n\u003cp\u003eOur results showed that for the vonoprazan-minocycline quadruple regimen in rescue therapy, the ITT, mITT, and PP eradication rates for the 10-day group were 81.63%, 95.24%, and 95.12%, respectively. In the 14-day group, the ITT, mITT, and PP eradication rates were 85.25%, 96.30%, and 96.15%, respectively, with no statistically significant differences observed between the two groups (\u003cem\u003ep\u003c/em\u003e \u0026gt; 0.05). These findings demonstrate that in the rescue therapy population, the vonoprazan-minocycline-based quadruple therapy achieves eradication rates exceeding 95% in both mITT and PP analyses, regardless of whether a 10-day or 14-day duration is used. This indicates that the quadruple regimen provides high eradication rates and significant therapeutic efficacy for patients with refractory H. pylori infection.\u003c/p\u003e\n\u003cp\u003eThis study utilized the bismuth-containing quadruple therapy recommended by the Maastricht VI/Florence consensus and achieved a satisfactory H. pylori eradication rate. This success may be attributed to the combination of a novel acid suppressant and specific antibiotics\u003csup\u003e5\u003c/sup\u003e. Vonoprazan is characterized by its rapid onset of action, potent acid suppression, and sustained duration. It increases intragastric pH in the early stages of treatment and maintains elevated pH levels over time. Furthermore, the antibacterial efficacy of amoxicillin against H. pylori is pH-dependent, meaning that a higher intragastric pH facilitates its bactericidal activity\u003csup\u003e6\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eMinocycline is a semi-synthetic tetracycline antibiotic. It primarily inhibits protein synthesis by binding to the 30S ribosomal subunit of bacteria, thereby exerting a broad-spectrum antibacterial effect. Compared with traditional tetracycline, minocycline possesses higher lipophilicity and superior oral bioavailability, leading to more extensive distribution and accumulation within the gastric mucosal tissues. Moreover, it maintains relatively stable activity even in acidic environments\u003csup\u003e7\u003c/sup\u003e. Dual therapies combining novel acid suppressants and minocycline have demonstrated excellent outcomes in several studies. Recent high-quality randomized controlled trials (RCTs) have indicated that vonoprazan-minocycline dual therapy is non-inferior to either bismuth-containing quadruple therapy or vonoprazan-amoxicillin dual therapy. There were no statistically significant differences in either eradication rates or adverse reactions\u003csup\u003e8,9\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eAlthough endoscopic biopsy-based bacterial culture and drug susceptibility testing (DST) can guide individualized treatment for patients with multiple eradication failures\u003csup\u003e10\u003c/sup\u003e, this strategy is constrained in clinical practice by its invasive nature, stringent laboratory requirements, and inconsistent success rates, which limit its practical accessibility. Consequently, empirical anti-H. pylori therapy remains the primary choice for most patients requiring rescue treatment. Therefore, selecting a combination of effective antibiotics and potent acid suppressants is of paramount importance. To this end, this study utilized a quadruple regimen consisting of vonoprazan, minocycline, amoxicillin, and bismuth pectin.\u003c/p\u003e\n\u003cp\u003ePrevious studies have shown that the eradication rates of traditional proton pump inhibitor (PPI)-bismuth quadruple therapy (BQT) in rescue therapy populations typically range from 70% to 85%. Particularly in regions with high resistance to clarithromycin and metronidazole, the failure rate of secondary eradication remains high\u003csup\u003e11,12\u003c/sup\u003e. However, multiple in vitro monitoring studies have indicated that the resistance rate of H. pylori to minocycline is generally below 2%\u003csup\u003e13,14\u003c/sup\u003e. Furthermore, minocycline possesses certain tissue penetration capabilities, which may contribute to improving the success rate of rescue eradication\u003csup\u003e7,15\u003c/sup\u003e. One study found that resistance to clarithromycin and levofloxacin does not compromise the efficacy of minocycline, with rescue eradication rates reaching up to 97.3%\u003csup\u003e16\u003c/sup\u003e. Moreover, several studies suggested that BQT regimens combining minocycline or other tetracyclines with bismuth and a PPI mostly achieved ITT eradication rates between 80% and 90%, with PP rates approaching or exceeding 95%\u003csup\u003e13,17,18\u003c/sup\u003e. In the context of high antibiotic resistance and previous treatment failure, the regimen in this study maintained a high level of eradication efficacy. This strongly underscores the clinical value of the vonoprazan-minocycline-based quadruple regimen for the rescue therapy population.\u003c/p\u003e\n\u003cp\u003eRegarding adverse drug reactions (ADRs), the symptoms reported by rescue therapy patients in both the 10-day and 14-day groups were primarily dizziness (6.25% vs. 11.67%) and mild-to-moderate gastrointestinal reactions. Common manifestations included acid regurgitation/belching/heartburn (8.33% vs. 11.67%), nausea/vomiting (8.33% vs. 8.33%), and abdominal pain/distention (2.08% vs. 10.00%). In most cases, these symptoms gradually resolved after treatment cessation. The incidence of dizziness/vertigo was lower in the 10-day group than in the 14-day group (6.25% vs. 11.67%), suggesting a potential correlation between this ADR and the extended treatment duration or cumulative exposure to minocycline. However, no statistically significant difference was found between the two groups (\u003cem\u003ep\u003c/em\u003e = 0.514). Additionally, one case of fungal vaginitis occurred in the 10-day rescue therapy group, which was likely associated with antibiotic-induced microbial dysbiosis. This highlights the need to monitor for dysbiosis and the risk of secondary infections during clinical antibiotic administration.\u003c/p\u003e\n\u003cp\u003eMinocycline possesses high lipophilicity and can reach significant concentrations in the cerebrospinal fluid, thereby inducing central vestibular symptoms such as dizziness and vertigo. However, these reactions typically subside gradually during the treatment and resolve rapidly upon discontinuation, indicating that they are primarily reversible adverse effects\u003csup\u003e19\u003c/sup\u003e. Patients with a history of motion sickness or recurrent vertigo may exhibit heightened sensitivity in the vestibular center\u0026apos;s integration of motion stimuli\u003csup\u003e20\u003c/sup\u003e. For such populations, clinicians should be more cautious in selecting this regimen and strengthen patient education and follow-up during the initial phase of treatment. Early reminders should be provided to avoid driving or performing high-risk operations. Overall, provided that minocycline is used at conventional dosages, the safety of this regimen remains within an acceptable range.\u003c/p\u003e\n\u003cp\u003eTreatment duration is another critical factor influencing H. pylori eradication rates and patient adherence. Traditional views suggest that extending the treatment duration helps improve eradication rates; thus, 14-day regimens are widely recommended\u003csup\u003e10,21\u003c/sup\u003e. However, longer durations may simultaneously increase the risk of adverse reactions and the overall treatment burden. For the vonoprazan-minocycline-bismuth quadruple therapy, no statistically significant difference in eradication rates was found between the 10-day and 14-day regimens (\u003cem\u003ep\u003c/em\u003e \u0026gt; 0.05).\u003c/p\u003e\n\u003cp\u003eIn the rescue therapy PP analysis, the ICER reached 11,548.83 CNY. This indicates that for patients with good adherence, the marginal efficacy gain (approximately 1%) from extending the duration to 14 days comes at a substantial economic cost and a higher risk of adverse reactions, suggesting that the 10-day regimen possesses a superior pharmacoeconomic advantage. In summary, for patients with good adherence and reliable follow-up, the 10-day regimen provides an optimal balance between therapeutic efficacy and treatment burden. It also helps reduce total antibiotic exposure and medication expenditures. Nevertheless, for patients with multiple prior treatment failures and significant therapeutic pressure, clinicians may still opt for the 14-day regimen based on experience to mitigate the potential risk of failure due to insufficient duration. Future studies could explore shortening the duration further to 7 days to evaluate its clinical efficacy and feasibility, thereby reducing the public health burden.\u003c/p\u003e\n\u003cp\u003eAdditionally, analysis of the patients\u0026apos; baseline conditions prior to treatment revealed no statistically significant differences across various indicators. However, in the comparison of pre-treatment symptoms, certain items exhibited statistical differences. This may be attributed to the relatively small sample size, which is prone to sampling errors, as well as the inherent heterogeneity among the consecutively enrolled patients. Pre-treatment symptoms are inherently subjective and do not represent objective biochemical indicators; thus, substantial variations exist between individuals. Therefore, these statistical differences lack clinical significance.\u003c/p\u003e\n\u003cp\u003eThis study has several limitations. First, the single-center, prospective, non-randomized design may limit the findings. Although we followed a strict protocol, the non-randomized nature of the study means that residual confounding and selection bias cannot be entirely ruled out. Second, the proportion of patients lost to follow-up was relatively high. This might have underestimated the eradication rates in the ITT analysis and introduced potential attrition bias. Third, the economic evaluation only accounted for direct medication costs, excluding expenses related to outpatient visits, laboratory tests, and follow-up urea breath tests.Consequently, the ICER results may be conservative and do not fully reflect the total costs from a healthcare system or societal perspective. Fourth, because H. pylori culture and drug-resistance gene testing were not systematically performed, we could not directly correlate resistance genotypes with therapeutic outcomes; thus, inferences were limited to empirical treatment results. Fifth, the follow-up focused on short-term eradication results at one month post-treatment. The lack of 6-month follow-up data limits our ability to assess the risk of recrudescence and long-term recurrence rates.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003e1. The vonoprazan-minocycline-bismuth quadruple regimen exhibits high clinical utility in patients with \u003cem\u003eH. pylori\u003c/em\u003einfection and can serve as a preferred strategy for rescue therapy.\u003c/p\u003e \u003cp\u003e2. For the vonoprazan-minocycline-based regimen, the 10-day duration achieves eradication efficacy comparable to that of the 14-day duration. Furthermore, the 10-day regimen is associated with a lower incidence of adverse reactions and a more significant pharmacoeconomic advantage, making it the recommended duration for clinical practice.\u003c/p\u003e "},{"header":"Declarations","content":"\u003ch2\u003eFunding \u003c/h2\u003e\n\u003cp\u003eThe authors declare that no funding was received for this study.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eX.Q. and Q.W. conceived and designed the study. X.Q., H.M., F.Z., R.L., and Y.H. were responsible for patient recruitment, clinical data collection, and follow-up interviews. X.Q. and H.M. performed the statistical analyses and the pharmacoeconomic evaluation. X.Q. wrote the main manuscript text. Q.W. provided supervision, managed the project, and performed critical revisions of the manuscript. All authors reviewed the manuscript and approved the final version for submission.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe datasets generated and/or analysed during the current study are not publicly available due to patient privacy and confidentiality but are available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eFischbach, W. \u0026amp; Malfertheiner, P. Helicobacter Pylori Infection. \u003cem\u003eDtsch. 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(2019). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/hel.12597\u003c/span\u003e\u003cspan address=\"10.1111/hel.12597\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"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":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Vonoprazan, Minocycline, Helicobacter pylori, Bismuth-containing quadruple therapy, Pharmacoeconomics","lastPublishedDoi":"10.21203/rs.3.rs-9429094/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9429094/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo evaluate the eradication efficacy of a quadruple regimen combining vonoprazan, amoxicillin, minocycline, and bismuth in patients requiring rescue therapy for Helicobacter pylori (H. pylori) infection, and to compare the differences in eradication rates and safety between 10-day and 14-day treatment durations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study used a single-center, prospective, non-randomized interventional design. Patients were assigned to either a 10-day or a 14-day treatment group. The primary outcome was the result of the urea breath test (UBT) performed one month after treatment completion, and eradication rates were calculated using intention-to-treat (ITT), modified intention-to-treat (mITT), and per-protocol(PP) analyses. Adverse drug reactions were recorded, and the incremental cost-effectiveness ratio (ICER) was calculated.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the comparison of different treatment durations for the vonoprazan and minocycline-containing regimen, the ITT eradication rates for the 10-day and 14-day rescue therapy groups were 81.63% and 85.25%, respectively (\u003cem\u003ep\u003c/em\u003e = 0.611). The mITT eradication rates were 95.24% (40/42) and 96.30% (52/54), and the PP eradication rates were 95.12% (39/41) and 96.15% (50/52), with no statistically significant differences (\u003cem\u003ep\u003c/em\u003e = 1.000). Regarding safety, the adverse reaction rates in the 10-day and 14-day groups were 20.83% and 26.67%, respectively (\u003cem\u003ep\u003c/em\u003e = 0.484). In the economic evaluation, the ICER of the 14-day regimen compared with the 10-day regimen in the PP population was 11,548.83.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1.The vonoprazan-minocycline-bismuth quadruple regimen demonstrates high clinical value and represents an optimal strategy for H. pylori rescue therapy.\u003c/p\u003e\n\u003cp\u003e2.For the vonoprazan-minocycline regimen, the 10-day and 14-day treatment durations provide comparable eradication efficacy. Furthermore, the 10-day regimen shows a lower incidence of adverse reactions and more significant pharmacoeconomic advantages, supporting its use as the preferred clinical duration.\u003c/p\u003e","manuscriptTitle":"Clinical application of a 10-day vonoprazan and minocycline-containing quadruple regimen for Helicobacter pylori rescue therapy","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-21 14:52:57","doi":"10.21203/rs.3.rs-9429094/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewersInvited","content":"","date":"2026-04-30T17:26:43+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-30T17:22:47+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-04-21T06:07:09+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-04-18T13:36:36+00:00","index":"","fulltext":""},{"type":"submitted","content":"Scientific Reports","date":"2026-04-18T13:31:06+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"6f775d8b-77e7-4e1e-b4e9-afda5bddcdf9","owner":[],"postedDate":"April 21st, 2026","published":true,"recentEditorialEvents":[{"type":"reviewersInvited","content":"11","date":"2026-04-30T17:26:43+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-30T17:22:47+00:00","index":"","fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":66620787,"name":"Health sciences/Diseases"},{"id":66620788,"name":"Biological sciences/Drug discovery"},{"id":66620789,"name":"Health sciences/Gastroenterology"},{"id":66620790,"name":"Health sciences/Medical research"},{"id":66620791,"name":"Biological sciences/Microbiology"}],"tags":[],"updatedAt":"2026-04-30T17:38:21+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-21 14:52:57","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9429094","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9429094","identity":"rs-9429094","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}