Efficacy and Safety of Mecapegfilgrastim for Prophylaxis of Neutropenia During Chemotherapy for Malignant Tumors: A Single-Center, Retrospective Cohort Study

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Mecapegfilgrastim was found to be more effective and safer than rhG-CSF in reducing neutropenia and related adverse events in cancer patients undergoing chemotherapy.

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This single-center retrospective cohort study analyzed 456 adult patients with solid malignant tumors at Jiading District Central Hospital (Dec 2018–Jun 2022) who developed chemotherapy-induced myelosuppression and received either mecapegfilgrastim (6 mg single subcutaneous injection 48 hours post-chemotherapy; n=266) or conventional short-acting rhG-CSF (n=190). Outcomes included time for ANC/WBC to fall below and return to normal, maintenance time, need for rescue/reuse of rhG-CSF, incidence of myelosuppression and febrile neutropenia, and adverse reactions, with groups reported as comparable in baseline gender, age, and BMI. The paper reports that mecapegfilgrastim delayed ANC/WBC declines (2.50 vs 6.83 days) and shortened recovery time (1.39 vs 4.16 days) and increased maintenance time (14.64 vs 7.75 days), with lower need for rhG-CSF reuse (4.81% vs 27.36%). It is limited by its retrospective, non-registered design and single-center setting. The paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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Abstract

Abstract Objective The objective of this study was to investigate the effectiveness and safety of prophylactic thiopefilgrastim for the clinical treatment of chemotherapy-induced neutropenia in cancer patients. Methods A retrospective analysis was performed to study 456 patients admitted to Jiading District Central Hospital from December 2018 to June 2022 who had malignant tumors and used either mecapegfilgrastim or recombinant human granulocyte stimulating factor (rhG-CSF) to treat chemotherapy-induced bone myelosuppression. The enrolled patients were divided according to the use of white blood cell-enhancing drugs into a mecapegfilgrastim group (experimental group) and an rhG-CSF group (control group). We collected and recorded patient information and analyzed the results. Results A total of 266 patients were enrolled in the experimental group, and 190 patients were enrolled in the control group. The two groups were significantly different in terms of treatment effect, the occurrence of bone marrow suppression and febrile neutropenia, and the occurrence of adverse reactions. Conclusion The preventative use of thiopefilgrastim can reduce the incidence of neutropenia caused by tumor chemotherapy, and it is more effective and safer than rhG-CSF. Trial Registration: Not applicable. This study is a retrospective analysis and was not registered as a clinical trial.
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Efficacy and Safety of Mecapegfilgrastim for Prophylaxis of Neutropenia During Chemotherapy for Malignant Tumors: A Single-Center, Retrospective Cohort Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Efficacy and Safety of Mecapegfilgrastim for Prophylaxis of Neutropenia During Chemotherapy for Malignant Tumors: A Single-Center, Retrospective Cohort Study Zhaojiao Guo, Jun Yan, Chun Wang, Weina Ma This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7978379/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective The objective of this study was to investigate the effectiveness and safety of prophylactic thiopefilgrastim for the clinical treatment of chemotherapy-induced neutropenia in cancer patients. Methods A retrospective analysis was performed to study 456 patients admitted to Jiading District Central Hospital from December 2018 to June 2022 who had malignant tumors and used either mecapegfilgrastim or recombinant human granulocyte stimulating factor (rhG-CSF) to treat chemotherapy-induced bone myelosuppression. The enrolled patients were divided according to the use of white blood cell-enhancing drugs into a mecapegfilgrastim group (experimental group) and an rhG-CSF group (control group). We collected and recorded patient information and analyzed the results. Results A total of 266 patients were enrolled in the experimental group, and 190 patients were enrolled in the control group. The two groups were significantly different in terms of treatment effect, the occurrence of bone marrow suppression and febrile neutropenia, and the occurrence of adverse reactions. Conclusion The preventative use of thiopefilgrastim can reduce the incidence of neutropenia caused by tumor chemotherapy, and it is more effective and safer than rhG-CSF. Trial Registration: Not applicable. This study is a retrospective analysis and was not registered as a clinical trial. mecapegfilgrastim tumor neutropenia chemotherapy 1 INTRODUCTION In recent years, morbidity and mortality caused by malignant tumors have been increasing in China. In clinical practice, the conventional methods for tumor treatment are surgery, radiotherapy, chemotherapy, immunotherapy, and comprehensive therapy. However, these techniques have some drawbacks, such as unsatisfactory therapeutic results, substantial toxicity, and adverse side effects [ 1 ] . Chemotherapy is the primary method used to prevent and treat cancer. However, the cytotoxicity of chemotherapy drugs can cause a decrease in the absolute neutrophil count (ANC) and white blood cell count (WBC), in addition to febrile neutropenia (FN) and myelosuppression. These effects influence the efficacy of chemotherapy for some patients and can put at risk patients' safety in more severe cases. Pegylated recombinant human granulocyte-stimulating factor (PEG-rhG-CSF) is a long-acting formulation of recombinant human granulocyte-stimulating factor (rhG-CSF). While both PEG-rhG-CSF and rhG-CSF have been shown to prevent FN, neutropenia, leukopenia, and myelosuppression during chemotherapy, PEG-rhG-CSF has been demonstrated to improve the limitations of rhG-CSF, such as short half-life and poor patient compliance. A previous study by Kumari et al. [ 2 ] demonstrated that PEG-rhG-CSF significantly prolongs the proliferation of WBCs and has stronger biological activity. Mecapegfilgrastim is a biological product independently developed by China and was approved by the (Chinese) National Medical Products Administration for marketing in 2018. It is a structural improvement of the existing PEG-rhG-CSF. Through a specific modification of polyethylene glycol maleimide, the rhG-CSF derived from mercaptopropionaldehyde has the same mechanism of action as PEG-rhG-CSF and has been patented in many countries [ 3 ] . A previous study by Wang et al. [ 4 ] showed that the incidence of neutropenia in patients administered with mecapegfilgrastim was lower than that in patients administered rhG-CSF, and mecapegfilgrastim had better clinical efficacy. There was no difference in drug-related adverse events. Since mecapegfilgrastim was only officially approved for marketing in 2018, there are limited clinical investigations. Thus, this study aimed to evaluate the efficacy and safety of mecapegfilgrastim by assessing the clinical effects in the prevention of neutropenia during tumor chemotherapy. 2 MATERIALS AND METHODS 2.1 General information A total of 456 patients in Jiading District Central Hospital were enrolled in this study from December 2018 to June 2022. The patients had solid tumors and received mecapegfilgrastim or rhG-CSF after chemotherapy-induced myelosuppression. The inclusion criteria were: (1) diagnosed with malignant disease, (2) patients were given mecapegfilgrastim and rhG-CSF, (3) age ≥ 18 years, and (4) both the ANC and WBC were within the normal range before enrollment. The exclusion criteria included: (1) pregnant and breastfeeding women, (2) allergic to mecapegfilgrastim, PEG-rhG-CSF, rhG-CSF, or other drugs purified from transfected Escherichia coli cultures. 2.2 Grouping of patients The enrolled patients were divided into groups based on the WBC-elevating agents administered after myelosuppression: 1) mecapegfilgrastim (experimental group) and 2) rhG-CSF (control group). Patients with myelosuppression and FN after chemotherapy were actively treated with mecapegfilgrastim or rhG-CSF 2.3 Treatment options All patients in the experimental group were treated with a single subcutaneous injection of mecapegfilgrastim, in a fixed dose of 6 mg per injection, 48 hours after the end of the chemotherapy cycle. If the patient's ANC continued to be lower than 0.5 × 10 9 /L for more than 24 hours after taking mecapegfilgrastim, it was necessary to decide whether to use short-acting rhG-CSF for rescue therapy to help restore the patient’s neutrophil levels to normal (white blood cells: 4–11 × 10 9 /L; the absolute value of neutrophils: 2–7 × 10 9 /L). The patients in the control group were administered subcutaneous or intravenous injections of rhG-CSF (2–5 µg/kg) daily when the ANC and WBC dropped below the normal range, and the administration was stopped once the ANC and WBC levels returned to the normal range. 2.4 Observation indicators The following information was collected and recorded from the enrolled patients: (1) gender, age, height, weight, BMI; (2) occurrence of myelosuppression and FN; (3) ANC and WBC before chemotherapy; (4) the number of days it took for the ANC and WBC to drop below the standard values after chemotherapy; (5) the number of days required for the ANC and WBC to return to normal values; (6) the maintenance time after the ANC and WBC returned to normal values; and (7) the incidence of adverse reactions during the treatment period until the ANC and WBC ratios returned to normal. 2.5 Statistical methods The SPSS 19.0 software was used for statistical analysis, and measurement data (age, BMI, the number of days for the ANC and WBC to drop below the standard values after chemotherapy, the number of days required for the ANC and WBC to return to normal values, and maintenance time after the ANC and WBC returned to normal values) were expressed as the mean ± standard deviation (x ± s). An analysis of variance was used for comparisons between groups, whereas χ 2 test was used for the qualitative data, and a t -test was used for the quantitative data. p < 0.05 indicated that the difference was statistically significant. 3 RESULTS 3.1 Clinical data Patients were divided into two groups, experimental group and control group, based on whether they were administered long-acting, WBC-elevating agents (mecapegfilgrastim) or short-acting, WBC-elevating agents (rhG-CSF). As shown in Table 1 , the two groups of patients did not significantly differ in gender, age, or BMI index. Table 1 Clinical data in the two groups of patients using PEG-rhG-CSF (experimental group) and rhG-CSF (control group) Item Experimental group (n = 266) Control group (n = 190) p-value Gender [n (%)] 0.42 Male 125 (46.99) 82 (43.16) Female 141 (53.01) 108 (56.84) Age (x ± s, years) 65.63 ± 10.08 63.92 ± 11.36 0.10 BMI [n (%)] 22.62 ± 3.25 22.58 ± 3.75 0.91 Underweight 17 (6.39) 10(5.26) Normal weight 194 (72.93) 137(72.11) Overweight 55 (20.68) 43(22.63) 3.2 Evaluation of therapeutic effects The number of days for the ANC and WBC to drop below the standard values after chemotherapy was 2.50 ± 2.02 in the experimental patient group and 6.83 ± 4.43 in the control group. In the experimental group, ANC and WBC required 1.39 ± 1.45 days to return to normal values after chemotherapy, while it took 4.16 ± 4.52 days for the control group. The maintenance time after the ANC and WBC returned to normal values were 14.64 ± 5.53 days in the experimental group and 7.75 ± 5.61 days in the control group. As shown in Table 2 , the two groups of patients significantly differed (p < 0.01) in three aspects: the number of days for the ANC and WBC to drop below the standard values after chemotherapy, the number of days required for the ANC and WBC to return to normal values after chemotherapy, and the maintenance time after the ANC and WBC returned to normal values. Table 2 Therapeutic effects in the two groups of patients using PEG-rhG-CSF (experimental group) and rhG-CSF (control group) Group Number of days for ANC and WBC to drop below standard values after chemotherapy Number of days required for ANC and WBC to return to normal values Maintenance time after ANC and WBC returned to normal values Experimental group (n = 126) 2.50 ± 2.02 1.39 ± 1.45 14.64 ± 5.53 Control group (n = 190) 6.83 ± 4.43 4.16 ± 4.52 7.75 ± 5.61 p-value < 0.01 < 0.01 < 0.01 12 patients in the experimental group were re-treated with rhG-CSF due to myelosuppression after chemotherapy, and 52 patients in the control group were re-treated with rhG-CSF. The incidence of re-use of rhG-CSF in the two groups was 4.51% and 27.36%.The number of days for re-use of rhG-CSF after chemotherapy was 14.42 ± 7.37 in the experimental patient group and 4.94 ± 5.25 in the control group. As shown in Table 3 , the two groups of patients significantly differed (p < 0.01) in three aspects. Table 3 Re-use of rhG-CSF in the two groups of patients using PEG-rhG-CSF (experimental group) and rhG-CSF (control group) Group Number of patients re-use rhG-CSF after chemotherapy Incidence (%) Interval time of re-use rhG-CSF after chemotherapy Experimental group (n = 266) 12 4.81 14.42 ± 7.37 Control group (n = 190) 52 27.36 4.94 ± 5.25 p-value < 0.01 < 0.01 3.3 Analysis of myelosuppression and FN In the experimental group, 183 patients developed myelosuppression after chemotherapy, with an incidence rate of 68.80%, 2 patients developed FN. In the control group, 190 patients developed myelosuppression after chemotherapy, with an incidence rate of 100%, and 74 patients developed FN, with an incidence rate of 38.95%. As shown in Table 4 , the two groups were not significantly different (p > 0.05) in the occurrence of myelosuppression. However, the occurrence of FN was significantly different (p < 0.01) between the two groups. Table 4 Occurrence of myelosuppression and FN in the two groups of patients usingPEG-rhG-CSF (experimental group) and rhG-CSF (control group) Group Myelosuppression Incidence (%) FN Incidence (%) Experimental group (n = 266) 183 68.80 2 0.75 Control group (n = 190) 190 100 74 38.95 p-value < 0.01 < 0.01 3.4 Occurrence of adverse reactions There were 36 cases of adverse reactions reported in the patients in the experimental group after using mecapegfilgrastim, including 5 cases of fatigue, 3 cases of musculoskeletal pain, 1 case of pharyngalgia and 27 cases of leukocytosis, There were no reports of fever, skin itching, rash, or oral mucosal discomfort, and the overall incidence rate of adverse reactions in the experimental group was 13.53%. In the control group, 33 cases of adverse reactions were reported after using rhG-CSF, including 3 cases of fatigue, 2 cases of fever, 2 cases of musculoskeletal pain,23 cases of leukocytosis, 1 case of skin itching, 1 case of rash, and 1 case of oral mucosa discomfort. The total incidence rate of adverse reactions in the control group was 17.37%. As shown in Table 5 , the two groups were non-significantly different (p = 0.26) in the occurrence of adverse reactions. Table 5 Occurrence of adverse reactions in the two groups of patients using PEG-rhG-CSF (experimental group) and rhG-CSF (control group) Group Fatigue Fever Musculoskeletal pain Itching skin Rash Oral mucosal discomfort Pharyngalgia Leukocytosis The overall incidence (%) Experimental group (n = 266) 5 0 3 0 0 0 1 27 13.53 Control group (n = 190) 3 2 2 1 1 1 0 23 17.37 p-value 0.26 4 DISCUSSION Chemotherapy drugs destroy both normal cells and tumor cells, causing a decrease in the number of neutrophils and white blood cells, which makes neutropenia the most common adverse reaction of chemotherapy [ 5 ] . Different degrees of neutropenia and myelosuppression can affect the human body, and in the most severe cases may lead to death. Both PEG-rhG-CSF and rhG-CSF are commonly used clinical medications for the treatment of chemotherapy-induced neutropenia and leukopenia. Clinical studies have shown that PEG-rhG-CSF is a long-acting dosage form of rhG-CSF. A single administration of PEG-rhG-CSF has been shown to improve both ANC and WBC and relieve the pain of continuous injection of medication as compared with rhG-CSF [ 6 ] . The mechanism of action of mecapegfilgrastim is the same as that of PEG-rhG-CSF, and because PEG itself has no obvious biological activity, the mechanism of action of PEG-rhG-CSF is the same as that of rhG-CSF, which stimulates the release of hematopoietic stem cells from the bone marrow into the peripheral blood. Since sufficient peripheral blood hematopoietic stem cells can be mobilized after application, the effect of mecapegfilgrastim is better than the daily use of rhG-CSF [ 7 ] . The results of our study showed that the experimental group using mecapegfilgrastim was significantly better as compared with the rhG-CSF control group in three aspects: 1) the number of days for the ANC and WBC to drop below the standard values after chemotherapy, 2) the number of days required for the ANC and WBC to return to normal values after chemotherapy, and 3) the maintenance time after the ANC and WBC returned to normal values,4)the incidence of re-use of rhG-CSF.Thus, the therapeutic effect of mecapegfilgrastim on patients was significantly better than that of rhG-CSF. This corroborated our hypothesis that, as a structural upgrade to PEG-rhG-CSF, mecapegfilgrastim has better clinical efficacy in the treatment of FN and myelosuppression. Additionally, there was no significant difference between the control and experimental groups in the occurrence of myelosuppression and FN, but there was a statistically significant difference in the occurrence of FN. Only 2 patients of the 266 patients in the experimental group developed FN, which demonstrated that mecapegfilgrastim can effectively prevent and control the occurrence of FN in patients after chemotherapy. The incidence of adverse reactions in the experimental group significantly differed from the control group, indicating that the use of mecapegfilgrastim is safer than the use of rhG-CSF. Thus, the efficacy and safety of mecapegfilgrastim for the prevention of tumor chemotherapy-induced neutropenia are significantly better than that of rhG-CSF. In accordance with our results, a study by Xu et al. [ 8 ] showed that mecapegfilgrastim was very effective and well-tolerated in both primary prevention and continuous cycles of treatment for chemotherapy-induced neutropenia; in some clinical parameters, mecapegfilgrastim was not inferior and in some cases was even superior to rhG-CSF. A study by Zhou et al. [ 9 ] showed that mecapegfilgrastim can effectively reduce the incidence of neutropenia, and it is comparable to daily use of rhG-CSF in terms of treatment endpoints and safety. In a real-world study conducted by Ma et al. [ 10 ] , mecapegfilgrastim was generally well-tolerated, no unexpected adverse events were observed, and continuous administration of mecapegfilgrastim maintained the incidence of neutropenia at relatively low levels. In conclusion, prophylactic use of mecapegfilgrastim reduced the incidence of neutropenia caused by tumor chemotherapy when compared to rhG-CSF. Thus, mecapegfilgrastim may be more effective and safer to use clinically for the prevention and treatment of solid tumors. Abbreviations ANC Absolute Neutrophil Count BMI Body Mass Index FN Febrile Neutropenia PEG-rhG-CSF Pegylated Recombinant Human Granulocyte-Colony Stimulating Factor rhG-CSF Recombinant Human Granulocyte-Colony Stimulating Factor WBC White Blood Cell Count Declarations Ethical Approval and Consent to Participate This retrospective study was conducted in accordance with the Declaration of Helsinki and was approved by the Medical Ethics Committee of Jiading District Central Hospital Affiliated Shanghai University of Medicine \& Health Sciences (Approval Number: 021849). The need for individual informed consent was waived by the ethics committee due to the retrospective nature of the study. Consent for publication Not applicable. Conflicts of Interest The authors declared that they have no conflicts of interest regarding this work. Funding This work was supported by Shanghai Key Specialty Project of Clinical Pharmacy (No.YXZDZK-01), and the Nature Science Foundation of Jiading District, Shanghai (No.JDKW-2021-0043). Author Contribution Zhaojiao Guo: Conceptualization, Data Curation, Writing - Original Draft. Jun Yan: Formal Analysis, Investigation. Chun Wang: Methodology, Resources. Weina Ma: Supervision, Project Administration, Writing - Review & Editing. All authors read and approved the final manuscript. Acknowledgement None. Data Availability The data used to support the findings of this study are available from the corresponding author upon reasonable request. References Huang Xiaoguang L, Canfeng L, Lianxing, et al. Effects of pegylated recombinant human granulocyte stimulating factor injection on granulocytes in cancer patients [J]. J Practical Cancer. 2020;35(07):1166–. Kumari M, Sahni G, Datta S. Development of Site-Specific PEGylated Granulocyte Colony Stimulating Factor With Prolonged Biological Activity[J]. Front Bioeng Biotechnol. 2020;8:572077. Ma J, Qin SM, Zhu J, et al. Expert consensus on clinical application of mecapegfilgrastim. Chin Clin Oncol. 2020;25(5):461–5. Wang T, Wu B, Hu X, et al. A randomized multicenter phase II trial of mecapegfilgrastim single administration versus granulocyte colony-stimulating growth factor on treating chemotherapy-induced neutropenia in breast cancer patients[J]. Ann Transl Med. 2019;7(9):196. Wang L, Yan XJ, He J. Comparison of PEG-rhG-CSF and G-CSF in the prevention of neutrophil deficiency in lymphoma patients after chemotherapy. J Mod Oncol. 2021;29(7):1215–9. Wang LM, Meng CY, Sun SN, et al. Role of pegylated recombinant human granulocyte stimulating factor in preventing chemotherapy-induced granulocytopenia in ovarian cancer. Med J Chin People's Armed Police Forces. 2020;31(7):609–11. Yang S, He XH, Shi YK. Study and application of pegylated recombinant human granulocyte colonysti-mulating factor. Chin Pharm J. 2005;40(17):1281–5. Xu F, Zhang Y, Miao Z, et al. Efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial[J]. Ann Transl Med. 2019;7(18):482. Zhou C, Huang Y, Wang D, et al. A Randomized Multicenter Phase III Study of Single Administration of Mecapegfilgrastim (HHPG-19K), a Pegfilgrastim Biosimilar, for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)[J]. Clin Lung Cancer. 2016;17(2):119–. Ma J, Huang H, Fu P, et al. Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies: a real-world study[J]. Ann Transl Med. 2021;9(10):893. Additional Declarations No competing interests reported. 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In clinical practice, the conventional methods for tumor treatment are surgery, radiotherapy, chemotherapy, immunotherapy, and comprehensive therapy. However, these techniques have some drawbacks, such as unsatisfactory therapeutic results, substantial toxicity, and adverse side effects \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. Chemotherapy is the primary method used to prevent and treat cancer. However, the cytotoxicity of chemotherapy drugs can cause a decrease in the absolute neutrophil count (ANC) and white blood cell count (WBC), in addition to febrile neutropenia (FN) and myelosuppression. These effects influence the efficacy of chemotherapy for some patients and can put at risk patients' safety in more severe cases. Pegylated recombinant human granulocyte-stimulating factor (PEG-rhG-CSF) is a long-acting formulation of recombinant human granulocyte-stimulating factor (rhG-CSF). While both PEG-rhG-CSF and rhG-CSF have been shown to prevent FN, neutropenia, leukopenia, and myelosuppression during chemotherapy, PEG-rhG-CSF has been demonstrated to improve the limitations of rhG-CSF, such as short half-life and poor patient compliance. A previous study by Kumari et al. \u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e demonstrated that PEG-rhG-CSF significantly prolongs the proliferation of WBCs and has stronger biological activity.\u003c/p\u003e\u003cp\u003e Mecapegfilgrastim is a biological product independently developed by China and was approved by the (Chinese) National Medical Products Administration for marketing in 2018. It is a structural improvement of the existing PEG-rhG-CSF. Through a specific modification of polyethylene glycol maleimide, the rhG-CSF derived from mercaptopropionaldehyde has the same mechanism of action as PEG-rhG-CSF and has been patented in many countries \u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. A previous study by Wang et al. \u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e showed that the incidence of neutropenia in patients administered with mecapegfilgrastim was lower than that in patients administered rhG-CSF, and mecapegfilgrastim had better clinical efficacy. There was no difference in drug-related adverse events. Since mecapegfilgrastim was only officially approved for marketing in 2018, there are limited clinical investigations. Thus, this study aimed to evaluate the efficacy and safety of mecapegfilgrastim by assessing the clinical effects in the prevention of neutropenia during tumor chemotherapy.\u003c/p\u003e"},{"header":"2 MATERIALS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1 General information\u003c/h2\u003e\u003cp\u003eA total of 456 patients in Jiading District Central Hospital were enrolled in this study from December 2018 to June 2022. The patients had solid tumors and received mecapegfilgrastim or rhG-CSF after chemotherapy-induced myelosuppression. The inclusion criteria were: (1) diagnosed with malignant disease, (2) patients were given mecapegfilgrastim and rhG-CSF, (3) age\u0026thinsp;\u0026ge;\u0026thinsp;18 years, and (4) both the ANC and WBC were within the normal range before enrollment. The exclusion criteria included: (1) pregnant and breastfeeding women, (2) allergic to mecapegfilgrastim, PEG-rhG-CSF, rhG-CSF, or other drugs purified from transfected \u003cem\u003eEscherichia coli\u003c/em\u003e cultures.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2 Grouping of patients\u003c/h2\u003e\u003cp\u003eThe enrolled patients were divided into groups based on the WBC-elevating agents administered after myelosuppression: 1) mecapegfilgrastim (experimental group) and 2) rhG-CSF (control group). Patients with myelosuppression and FN after chemotherapy were actively treated with mecapegfilgrastim or rhG-CSF\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3 Treatment options\u003c/h2\u003e\u003cp\u003eAll patients in the experimental group were treated with a single subcutaneous injection of mecapegfilgrastim, in a fixed dose of 6 mg per injection, 48 hours after the end of the chemotherapy cycle. If the patient's ANC continued to be lower than 0.5 \u0026times; 10\u003csup\u003e9\u003c/sup\u003e/L for more than 24 hours after taking mecapegfilgrastim, it was necessary to decide whether to use short-acting rhG-CSF for rescue therapy to help restore the patient\u0026rsquo;s neutrophil levels to normal (white blood cells: 4\u0026ndash;11 \u0026times; 10\u003csup\u003e9\u003c/sup\u003e/L; the absolute value of neutrophils: 2\u0026ndash;7 \u0026times; 10\u003csup\u003e9\u003c/sup\u003e/L). The patients in the control group were administered subcutaneous or intravenous injections of rhG-CSF (2\u0026ndash;5 \u0026micro;g/kg) daily when the ANC and WBC dropped below the normal range, and the administration was stopped once the ANC and WBC levels returned to the normal range.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.4 Observation indicators\u003c/h2\u003e\u003cp\u003eThe following information was collected and recorded from the enrolled patients: (1) gender, age, height, weight, BMI; (2) occurrence of myelosuppression and FN; (3) ANC and WBC before chemotherapy; (4) the number of days it took for the ANC and WBC to drop below the standard values after chemotherapy; (5) the number of days required for the ANC and WBC to return to normal values; (6) the maintenance time after the ANC and WBC returned to normal values; and (7) the incidence of adverse reactions during the treatment period until the ANC and WBC ratios returned to normal.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003e2.5 Statistical methods\u003c/h2\u003e\u003cp\u003eThe SPSS 19.0 software was used for statistical analysis, and measurement data (age, BMI, the number of days for the ANC and WBC to drop below the standard values after chemotherapy, the number of days required for the ANC and WBC to return to normal values, and maintenance time after the ANC and WBC returned to normal values) were expressed as the mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (x\u0026thinsp;\u0026plusmn;\u0026thinsp;s). An analysis of variance was used for comparisons between groups, whereas χ\u003csup\u003e2\u003c/sup\u003e test was used for the qualitative data, and a \u003cem\u003et\u003c/em\u003e-test was used for the quantitative data. p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 indicated that the difference was statistically significant.\u003c/p\u003e\u003c/div\u003e"},{"header":"3 RESULTS","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\u003ch2\u003e3.1 Clinical data\u003c/h2\u003e\u003cp\u003ePatients were divided into two groups, experimental group and control group, based on whether they were administered long-acting, WBC-elevating agents (mecapegfilgrastim) or short-acting, WBC-elevating agents (rhG-CSF). As shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, the two groups of patients did not significantly differ in gender, age, or BMI index.\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\u003eClinical data in the two groups of patients using PEG-rhG-CSF (experimental group) and rhG-CSF (control group)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\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\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eItem\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eExperimental group (n\u0026thinsp;=\u0026thinsp;266)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eControl group (n\u0026thinsp;=\u0026thinsp;190)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003ep-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGender [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\u003e0.42\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=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e125 (46.99)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e82 (43.16)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\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=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e141 (53.01)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e108 (56.84)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (x\u0026thinsp;\u0026plusmn;\u0026thinsp;s, years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e65.63\u0026thinsp;\u0026plusmn;\u0026thinsp;10.08\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e63.92\u0026thinsp;\u0026plusmn;\u0026thinsp;11.36\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.10\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBMI [n (%)]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e22.62\u0026thinsp;\u0026plusmn;\u0026thinsp;3.25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e22.58\u0026thinsp;\u0026plusmn;\u0026thinsp;3.75\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.91\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUnderweight\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e17 (6.39)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e10(5.26)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNormal weight\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e194 (72.93)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e137(72.11)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOverweight\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e55 (20.68)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e43(22.63)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\u003ch2\u003e3.2 Evaluation of therapeutic effects\u003c/h2\u003e\u003cp\u003eThe number of days for the ANC and WBC to drop below the standard values after chemotherapy was 2.50\u0026thinsp;\u0026plusmn;\u0026thinsp;2.02 in the experimental patient group and 6.83\u0026thinsp;\u0026plusmn;\u0026thinsp;4.43 in the control group. In the experimental group, ANC and WBC required 1.39\u0026thinsp;\u0026plusmn;\u0026thinsp;1.45 days to return to normal values after chemotherapy, while it took 4.16\u0026thinsp;\u0026plusmn;\u0026thinsp;4.52 days for the control group. The maintenance time after the ANC and WBC returned to normal values were 14.64\u0026thinsp;\u0026plusmn;\u0026thinsp;5.53 days in the experimental group and 7.75\u0026thinsp;\u0026plusmn;\u0026thinsp;5.61 days in the control group. As shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, the two groups of patients significantly differed (p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) in three aspects: the number of days for the ANC and WBC to drop below the standard values after chemotherapy, the number of days required for the ANC and WBC to return to normal values after chemotherapy, and the maintenance time after the ANC and WBC returned to normal values.\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\u003eTherapeutic effects in the two groups of patients using PEG-rhG-CSF (experimental group) and rhG-CSF (control group)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\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\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGroup\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNumber of days for ANC and WBC to drop below standard values after chemotherapy\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNumber of days required for ANC and WBC to return to normal values\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMaintenance time after ANC and WBC returned to normal values\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eExperimental group (n\u0026thinsp;=\u0026thinsp;126)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2.50\u0026thinsp;\u0026plusmn;\u0026thinsp;2.02\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1.39\u0026thinsp;\u0026plusmn;\u0026thinsp;1.45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e14.64\u0026thinsp;\u0026plusmn;\u0026thinsp;5.53\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eControl group (n\u0026thinsp;=\u0026thinsp;190)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6.83\u0026thinsp;\u0026plusmn;\u0026thinsp;4.43\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4.16\u0026thinsp;\u0026plusmn;\u0026thinsp;4.52\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e7.75\u0026thinsp;\u0026plusmn;\u0026thinsp;5.61\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ep-value\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e12 patients in the experimental group were re-treated with rhG-CSF due to myelosuppression after chemotherapy, and 52 patients in the control group were re-treated with rhG-CSF. The incidence of re-use of rhG-CSF in the two groups was 4.51% and 27.36%.The number of days for re-use of rhG-CSF after chemotherapy was 14.42\u0026thinsp;\u0026plusmn;\u0026thinsp;7.37 in the experimental patient group and 4.94\u0026thinsp;\u0026plusmn;\u0026thinsp;5.25 in the control group. As shown in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e, the two groups of patients significantly differed (p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) in three aspects.\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\u003eRe-use of rhG-CSF in the two groups of patients using PEG-rhG-CSF (experimental group) and rhG-CSF (control group)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\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\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGroup\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNumber of patients re-use rhG-CSF after chemotherapy\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eIncidence (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eInterval time of re-use rhG-CSF after chemotherapy\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eExperimental group (n\u0026thinsp;=\u0026thinsp;266)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e4.81\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e14.42\u0026thinsp;\u0026plusmn;\u0026thinsp;7.37\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eControl group (n\u0026thinsp;=\u0026thinsp;190)\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\u003e27.36\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4.94\u0026thinsp;\u0026plusmn;\u0026thinsp;5.25\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ep-value\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003e3.3 Analysis of myelosuppression and FN\u003c/h2\u003e\u003cp\u003eIn the experimental group, 183 patients developed myelosuppression after chemotherapy, with an incidence rate of 68.80%, 2 patients developed FN. In the control group, 190 patients developed myelosuppression after chemotherapy, with an incidence rate of 100%, and 74 patients developed FN, with an incidence rate of 38.95%. As shown in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e, the two groups were not significantly different (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05) in the occurrence of myelosuppression. However, the occurrence of FN was significantly different (p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) between the two groups.\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\u003eOccurrence of myelosuppression and FN in the two groups of patients usingPEG-rhG-CSF (experimental group) and rhG-CSF (control group)\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=\"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\u003eGroup\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMyelosuppression\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eIncidence (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eFN\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eIncidence (%)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eExperimental group (n\u0026thinsp;=\u0026thinsp;266)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e183\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e68.80\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.75\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eControl group (n\u0026thinsp;=\u0026thinsp;190)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e190\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e100\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e74\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e38.95\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ep-value\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003e3.4 Occurrence of adverse reactions\u003c/h2\u003e\u003cp\u003eThere were 36 cases of adverse reactions reported in the patients in the experimental group after using mecapegfilgrastim, including 5 cases of fatigue, 3 cases of musculoskeletal pain, 1 case of pharyngalgia and 27 cases of leukocytosis, There were no reports of fever, skin itching, rash, or oral mucosal discomfort, and the overall incidence rate of adverse reactions in the experimental group was 13.53%. In the control group, 33 cases of adverse reactions were reported after using rhG-CSF, including 3 cases of fatigue, 2 cases of fever, 2 cases of musculoskeletal pain,23 cases of leukocytosis, 1 case of skin itching, 1 case of rash, and 1 case of oral mucosa discomfort. The total incidence rate of adverse reactions in the control group was 17.37%. As shown in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e, the two groups were non-significantly different (p\u0026thinsp;=\u0026thinsp;0.26) in the occurrence of adverse reactions.\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\u003eOccurrence of adverse reactions in the two groups of patients using PEG-rhG-CSF (experimental group) and rhG-CSF (control group)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"11\"\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=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGroup\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eFatigue\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eFever\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMusculoskeletal pain\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eItching skin\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eRash\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003eOral mucosal discomfort\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u003cp\u003ePharyngalgia\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c9\"\u003e\u003cp\u003eLeukocytosis\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c10\"\u003e\u003cp\u003eThe overall incidence (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eExperimental group (n\u0026thinsp;=\u0026thinsp;266)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e13.53\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eControl group (n\u0026thinsp;=\u0026thinsp;190)\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\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e17.37\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ep-value\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\u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e\u003cp\u003e0.26\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"4 DISCUSSION","content":"\u003cp\u003eChemotherapy drugs destroy both normal cells and tumor cells, causing a decrease in the number of neutrophils and white blood cells, which makes neutropenia the most common adverse reaction of chemotherapy \u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e. Different degrees of neutropenia and myelosuppression can affect the human body, and in the most severe cases may lead to death. Both PEG-rhG-CSF and rhG-CSF are commonly used clinical medications for the treatment of chemotherapy-induced neutropenia and leukopenia. Clinical studies have shown that PEG-rhG-CSF is a long-acting dosage form of rhG-CSF. A single administration of PEG-rhG-CSF has been shown to improve both ANC and WBC and relieve the pain of continuous injection of medication as compared with rhG-CSF \u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eThe mechanism of action of mecapegfilgrastim is the same as that of PEG-rhG-CSF, and because PEG itself has no obvious biological activity, the mechanism of action of PEG-rhG-CSF is the same as that of rhG-CSF, which stimulates the release of hematopoietic stem cells from the bone marrow into the peripheral blood. Since sufficient peripheral blood hematopoietic stem cells can be mobilized after application, the effect of mecapegfilgrastim is better than the daily use of rhG-CSF \u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eThe results of our study showed that the experimental group using mecapegfilgrastim was significantly better as compared with the rhG-CSF control group in three aspects: 1) the number of days for the ANC and WBC to drop below the standard values after chemotherapy, 2) the number of days required for the ANC and WBC to return to normal values after chemotherapy, and 3) the maintenance time after the ANC and WBC returned to normal values,4)the incidence of re-use of rhG-CSF.Thus, the therapeutic effect of mecapegfilgrastim on patients was significantly better than that of rhG-CSF. This corroborated our hypothesis that, as a structural upgrade to PEG-rhG-CSF, mecapegfilgrastim has better clinical efficacy in the treatment of FN and myelosuppression. Additionally, there was no significant difference between the control and experimental groups in the occurrence of myelosuppression and FN, but there was a statistically significant difference in the occurrence of FN. Only 2 patients of the 266 patients in the experimental group developed FN, which demonstrated that mecapegfilgrastim can effectively prevent and control the occurrence of FN in patients after chemotherapy. The incidence of adverse reactions in the experimental group significantly differed from the control group, indicating that the use of mecapegfilgrastim is safer than the use of rhG-CSF. Thus, the efficacy and safety of mecapegfilgrastim for the prevention of tumor chemotherapy-induced neutropenia are significantly better than that of rhG-CSF.\u003c/p\u003e\u003cp\u003eIn accordance with our results, a study by Xu et al. \u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e showed that mecapegfilgrastim was very effective and well-tolerated in both primary prevention and continuous cycles of treatment for chemotherapy-induced neutropenia; in some clinical parameters, mecapegfilgrastim was not inferior and in some cases was even superior to rhG-CSF. A study by Zhou et al. \u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e showed that mecapegfilgrastim can effectively reduce the incidence of neutropenia, and it is comparable to daily use of rhG-CSF in terms of treatment endpoints and safety. In a real-world study conducted by Ma et al. \u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e, mecapegfilgrastim was generally well-tolerated, no unexpected adverse events were observed, and continuous administration of mecapegfilgrastim maintained the incidence of neutropenia at relatively low levels.\u003c/p\u003e\u003cp\u003eIn conclusion, prophylactic use of mecapegfilgrastim reduced the incidence of neutropenia caused by tumor chemotherapy when compared to rhG-CSF. Thus, mecapegfilgrastim may be more effective and safer to use clinically for the prevention and treatment of solid tumors.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eANC\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eAbsolute Neutrophil Count\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eBMI\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eBody Mass Index\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eFN\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eFebrile Neutropenia\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003ePEG-rhG-CSF\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003ePegylated Recombinant Human Granulocyte-Colony Stimulating Factor\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003erhG-CSF\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eRecombinant Human Granulocyte-Colony Stimulating Factor\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eWBC\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eWhite Blood Cell Count\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003ch2\u003eEthical Approval and Consent to Participate\u003c/h2\u003e\u003cp\u003eThis retrospective study was conducted in accordance with the Declaration of Helsinki and was approved by the Medical Ethics Committee of Jiading District Central Hospital Affiliated Shanghai University of Medicine \\\u0026amp; Health Sciences (Approval Number: 021849). The need for individual informed consent was waived by the ethics committee due to the retrospective nature of the study.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003cp\u003eNot applicable.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003ch2\u003eConflicts of Interest\u003c/h2\u003e\u003cp\u003eThe authors declared that they have no conflicts of interest regarding this work.\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e\u003cp\u003eThis work was supported by Shanghai Key Specialty Project of Clinical Pharmacy (No.YXZDZK-01), and the Nature Science Foundation of Jiading District, Shanghai (No.JDKW-2021-0043).\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eZhaojiao Guo: Conceptualization, Data Curation, Writing - Original Draft. Jun Yan: Formal Analysis, Investigation. Chun Wang: Methodology, Resources. Weina Ma: Supervision, Project Administration, Writing - Review \u0026amp;amp; Editing. All authors read and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eNone.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data used to support the findings of this study are available from the corresponding author upon reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHuang Xiaoguang L, Canfeng L, Lianxing, et al. Effects of pegylated recombinant human granulocyte stimulating factor injection on granulocytes in cancer patients [J]. J Practical Cancer. 2020;35(07):1166\u0026ndash;.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKumari M, Sahni G, Datta S. Development of Site-Specific PEGylated Granulocyte Colony Stimulating Factor With Prolonged Biological Activity[J]. Front Bioeng Biotechnol. 2020;8:572077.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMa J, Qin SM, Zhu J, et al. Expert consensus on clinical application of mecapegfilgrastim. Chin Clin Oncol. 2020;25(5):461\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWang T, Wu B, Hu X, et al. A randomized multicenter phase II trial of mecapegfilgrastim single administration versus granulocyte colony-stimulating growth factor on treating chemotherapy-induced neutropenia in breast cancer patients[J]. Ann Transl Med. 2019;7(9):196.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWang L, Yan XJ, He J. Comparison of PEG-rhG-CSF and G-CSF in the prevention of neutrophil deficiency in lymphoma patients after chemotherapy. J Mod Oncol. 2021;29(7):1215\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWang LM, Meng CY, Sun SN, et al. Role of pegylated recombinant human granulocyte stimulating factor in preventing chemotherapy-induced granulocytopenia in ovarian cancer. Med J Chin People's Armed Police Forces. 2020;31(7):609\u0026ndash;11.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eYang S, He XH, Shi YK. Study and application of pegylated recombinant human granulocyte colonysti-mulating factor. Chin Pharm J. 2005;40(17):1281\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eXu F, Zhang Y, Miao Z, et al. Efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial[J]. Ann Transl Med. 2019;7(18):482.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eZhou C, Huang Y, Wang D, et al. A Randomized Multicenter Phase III Study of Single Administration of Mecapegfilgrastim (HHPG-19K), a Pegfilgrastim Biosimilar, for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)[J]. Clin Lung Cancer. 2016;17(2):119\u0026ndash;.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMa J, Huang H, Fu P, et al. Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies: a real-world study[J]. Ann Transl Med. 2021;9(10):893.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"mecapegfilgrastim, tumor, neutropenia, chemotherapy","lastPublishedDoi":"10.21203/rs.3.rs-7978379/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7978379/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003eThe objective of this study was to investigate the effectiveness and safety of prophylactic thiopefilgrastim for the clinical treatment of chemotherapy-induced neutropenia in cancer patients.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eA retrospective analysis was performed to study 456 patients admitted to Jiading District Central Hospital from December 2018 to June 2022 who had malignant tumors and used either mecapegfilgrastim or recombinant human granulocyte stimulating factor (rhG-CSF) to treat chemotherapy-induced bone myelosuppression. The enrolled patients were divided according to the use of white blood cell-enhancing drugs into a mecapegfilgrastim group (experimental group) and an rhG-CSF group (control group). We collected and recorded patient information and analyzed the results.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eA total of 266 patients were enrolled in the experimental group, and 190 patients were enrolled in the control group. The two groups were significantly different in terms of treatment effect, the occurrence of bone marrow suppression and febrile neutropenia, and the occurrence of adverse reactions.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eThe preventative use of thiopefilgrastim can reduce the incidence of neutropenia caused by tumor chemotherapy, and it is more effective and safer than rhG-CSF.\u003c/p\u003e\u003ch2\u003eTrial Registration:\u003c/h2\u003e\u003cp\u003eNot applicable. This study is a retrospective analysis and was not registered as a clinical trial.\u003c/p\u003e","manuscriptTitle":"Efficacy and Safety of Mecapegfilgrastim for Prophylaxis of Neutropenia During Chemotherapy for Malignant Tumors: A Single-Center, Retrospective Cohort Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-18 05:48:03","doi":"10.21203/rs.3.rs-7978379/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"cf1a0cc6-6d1e-4f5c-bf1f-e779eac64680","owner":[],"postedDate":"November 18th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-12-22T06:09:23+00:00","versionOfRecord":[],"versionCreatedAt":"2025-11-18 05:48:03","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7978379","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7978379","identity":"rs-7978379","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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