{"title":"Vonoprazan-minocycline双重治疗作为幽门螺杆菌感染一线治疗与经验含铋四联治疗的比较。","authors":"Meng Li, Xiaolei Wang, Xinhong Dong, Guigen Teng, Yun Dai, Weihong Wang","doi":"10.1177/17562848251366156","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Increasing antibiotic resistance compromises therapeutic options for <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection, especially in penicillin-allergic individuals.</p><p><strong>Objectives: </strong>This trial aimed to assess the efficacy and safety of 14-day vonoprazan-minocycline (VM) dual therapy against bismuth-containing quadruple therapy (B-quadruple therapy), as initial treatment for <i>H. pylori</i> infection.</p><p><strong>Design: </strong>This study was a single-center, open-label, and non-inferiority randomized controlled trial.</p><p><strong>Methods: </strong>In this study, 240 individuals with <i>H. pylori</i> infection who have not received therapy were randomly assigned 1:1 to either the VM dual therapy group (vonoprazan 20 mg plus minocycline 100 mg, administered twice daily) or the B-quadruple therapy group (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all administered twice daily). The primary outcome was to evaluate the non-inferiority of eradication rates between the two groups. Secondary outcomes included assessments of AEs and compliance.</p><p><strong>Results: </strong>The eradication rates of VM dual group and B-quadruple therapy group were 87.5% and 88.3%, respectively, by intention-to-treat (ITT) analysis; 92.1% and 94.6% by modified ITT (mITT) analysis; and 92.0% and 95.5% by per-protocol (PP) analysis. The eradication rates of the VM group were non-inferior to those of the B-quadruple therapy group in ITT, mITT, and PP analyses (one-sided <i>p</i>-values were 0.02, 0.01, and 0.02). The incidence of AEs was higher in the B-quadruple therapy group (28.3%) than in the VM group (16.7%, <i>p</i> = 0.03). Good compliance was achieved in both groups (<i>p</i> = 0.60).</p><p><strong>Conclusion: </strong>The VM dual therapy was not inferior to the B-quadruple therapy in the initial treatment of <i>H. pylori</i> infection, and the incidence of AEs was lower compared to B-quadruple therapy.</p><p><strong>Trial registration: </strong>This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2400081461.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251366156"},"PeriodicalIF":3.4000,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12374092/pdf/","citationCount":"0","resultStr":"{\"title\":\"Vonoprazan-minocycline dual therapy as a first-line treatment of <i>Helicobacter pylori</i> infection compared with empirical bismuth-containing quadruple therapy.\",\"authors\":\"Meng Li, Xiaolei Wang, Xinhong Dong, Guigen Teng, Yun Dai, Weihong Wang\",\"doi\":\"10.1177/17562848251366156\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Increasing antibiotic resistance compromises therapeutic options for <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection, especially in penicillin-allergic individuals.</p><p><strong>Objectives: </strong>This trial aimed to assess the efficacy and safety of 14-day vonoprazan-minocycline (VM) dual therapy against bismuth-containing quadruple therapy (B-quadruple therapy), as initial treatment for <i>H. pylori</i> infection.</p><p><strong>Design: </strong>This study was a single-center, open-label, and non-inferiority randomized controlled trial.</p><p><strong>Methods: </strong>In this study, 240 individuals with <i>H. pylori</i> infection who have not received therapy were randomly assigned 1:1 to either the VM dual therapy group (vonoprazan 20 mg plus minocycline 100 mg, administered twice daily) or the B-quadruple therapy group (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all administered twice daily). The primary outcome was to evaluate the non-inferiority of eradication rates between the two groups. Secondary outcomes included assessments of AEs and compliance.</p><p><strong>Results: </strong>The eradication rates of VM dual group and B-quadruple therapy group were 87.5% and 88.3%, respectively, by intention-to-treat (ITT) analysis; 92.1% and 94.6% by modified ITT (mITT) analysis; and 92.0% and 95.5% by per-protocol (PP) analysis. The eradication rates of the VM group were non-inferior to those of the B-quadruple therapy group in ITT, mITT, and PP analyses (one-sided <i>p</i>-values were 0.02, 0.01, and 0.02). The incidence of AEs was higher in the B-quadruple therapy group (28.3%) than in the VM group (16.7%, <i>p</i> = 0.03). Good compliance was achieved in both groups (<i>p</i> = 0.60).</p><p><strong>Conclusion: </strong>The VM dual therapy was not inferior to the B-quadruple therapy in the initial treatment of <i>H. pylori</i> infection, and the incidence of AEs was lower compared to B-quadruple therapy.</p><p><strong>Trial registration: </strong>This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2400081461.</p>\",\"PeriodicalId\":48770,\"journal\":{\"name\":\"Therapeutic Advances in Gastroenterology\",\"volume\":\"18 \",\"pages\":\"17562848251366156\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-08-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12374092/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848251366156\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848251366156","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Vonoprazan-minocycline dual therapy as a first-line treatment of Helicobacter pylori infection compared with empirical bismuth-containing quadruple therapy.
Background: Increasing antibiotic resistance compromises therapeutic options for Helicobacter pylori (H. pylori) infection, especially in penicillin-allergic individuals.
Objectives: This trial aimed to assess the efficacy and safety of 14-day vonoprazan-minocycline (VM) dual therapy against bismuth-containing quadruple therapy (B-quadruple therapy), as initial treatment for H. pylori infection.
Design: This study was a single-center, open-label, and non-inferiority randomized controlled trial.
Methods: In this study, 240 individuals with H. pylori infection who have not received therapy were randomly assigned 1:1 to either the VM dual therapy group (vonoprazan 20 mg plus minocycline 100 mg, administered twice daily) or the B-quadruple therapy group (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all administered twice daily). The primary outcome was to evaluate the non-inferiority of eradication rates between the two groups. Secondary outcomes included assessments of AEs and compliance.
Results: The eradication rates of VM dual group and B-quadruple therapy group were 87.5% and 88.3%, respectively, by intention-to-treat (ITT) analysis; 92.1% and 94.6% by modified ITT (mITT) analysis; and 92.0% and 95.5% by per-protocol (PP) analysis. The eradication rates of the VM group were non-inferior to those of the B-quadruple therapy group in ITT, mITT, and PP analyses (one-sided p-values were 0.02, 0.01, and 0.02). The incidence of AEs was higher in the B-quadruple therapy group (28.3%) than in the VM group (16.7%, p = 0.03). Good compliance was achieved in both groups (p = 0.60).
Conclusion: The VM dual therapy was not inferior to the B-quadruple therapy in the initial treatment of H. pylori infection, and the incidence of AEs was lower compared to B-quadruple therapy.
Trial registration: This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2400081461.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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