{"title":"10天伏诺哌唑-阿莫西林双重治疗与14天埃索美拉唑-阿莫西林双重治疗一线幽门螺杆菌根除：一项前瞻性多中心随机对照试验","authors":"Ben-Gang Zhou, Ming-Wen Guo, Li-Juan Zhang, Zhi-Dong Liu, Chun-Hua Liu, Xue-Feng Li, Shun-Song Li, Peng Xiao, Bing Bao, Yao-Wei Ai, Yan-Bing Ding","doi":"10.1177/17562848241309870","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The efficacy of the 14-day esomeprazole-amoxicillin (EA) dual therapy in eradicating <i>Helicobacter pylori</i> (<i>H. pylori</i>) has been widely discussed previously. Vonoprazan, a novel potassium-competitive acid blocker, presents rapid, potent, and long-lasting acid inhibitory effects compared to esomeprazole. However, there is currently a scarcity of direct comparisons between the 10-day vonoprazan-amoxicillin (VA) and the 14-day EA dual therapy for <i>H. pylori</i> eradication.</p><p><strong>Objectives: </strong>This study aimed to compare the efficacy and safety of the 10-day VA and the 14-day EA dual therapy for <i>H. pylori</i> first-line eradication.</p><p><strong>Design: </strong>This study was a prospective, multicenter, open-label, randomized controlled trial.</p><p><strong>Methods: </strong>The study was conducted at 10 hospitals in China. In total, 570 newly diagnosed <i>H. pylori</i>-infected patients were recruited from April 2023 to February 2024. These patients were randomly assigned to either the 10-day VA group (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily) or the 14-day EA group (esomeprazole 20 mg four times daily + amoxicillin 750 mg four times daily). The primary outcome was the eradication rate, with secondary outcomes including adverse events and compliance.</p><p><strong>Results: </strong>The 10-day VA regimen outperformed the 14-day EA regimen in terms of eradication rates in intention-to-treat (ITT) analysis (85.4% vs 76.7%, <i>p</i> = 0.008), modified ITT analysis (90.7% vs 84.8%, <i>p</i> = 0.036), and per-protocol (PP) analysis (91.1% versus 85.5%, <i>p</i> = 0.047). The non-inferiority <i>p</i>-values in all three analyses were less than 0.001. No statistically significant difference was observed in the incidence of adverse events between the two groups (9.1% vs 11.7%, <i>p</i> = 0.308). The 10-day VA regimen demonstrated higher compliance compared to the 14-day EA regimen (<i>p</i> = 0.006).</p><p><strong>Conclusion: </strong>The 10-day VA dual therapy showed a satisfactory eradication rate of 91.1% (PP analysis), demonstrating good safety and better compliance compared to the 14-day EA dual therapy as the first-line eradication.</p><p><strong>Trial registration: </strong>This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2300070475) on April 12, 2023.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241309870"},"PeriodicalIF":3.9000,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11686653/pdf/","citationCount":"0","resultStr":"{\"title\":\"Ten-day vonoprazan-amoxicillin dual therapy versus 14-day esomeprazole-amoxicillin dual therapy for first-line <i>Helicobacter pylori</i> eradication: a prospective multicenter randomized controlled trial.\",\"authors\":\"Ben-Gang Zhou, Ming-Wen Guo, Li-Juan Zhang, Zhi-Dong Liu, Chun-Hua Liu, Xue-Feng Li, Shun-Song Li, Peng Xiao, Bing Bao, Yao-Wei Ai, Yan-Bing Ding\",\"doi\":\"10.1177/17562848241309870\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The efficacy of the 14-day esomeprazole-amoxicillin (EA) dual therapy in eradicating <i>Helicobacter pylori</i> (<i>H. pylori</i>) has been widely discussed previously. 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引用次数: 0
摘要
背景：14天埃索美拉唑-阿莫西林（EA）联合治疗根除幽门螺杆菌（H. pylori）的疗效已被广泛讨论。Vonoprazan是一种新型的钾竞争性酸阻滞剂，与埃索美拉唑相比，具有快速、有效和持久的酸抑制作用。然而，目前缺乏对10天vonoprazan-amoxicillin （VA）和14天EA双重治疗根除幽门螺杆菌的直接比较。目的：本研究旨在比较10天VA和14天EA双重治疗对幽门螺杆菌一线根除的疗效和安全性。设计：本研究是一项前瞻性、多中心、开放标签、随机对照试验。方法：在全国10家医院进行研究。从2023年4月到2024年2月，总共招募了570名新诊断的幽门螺杆菌感染患者。这些患者被随机分配到10天VA组（伏诺哌赞20毫克，每日2次+阿莫西林1000毫克，每日3次）或14天EA组（埃索美拉唑20毫克，每日4次+阿莫西林750毫克，每日4次）。主要终点是根除率，次要终点包括不良事件和依从性。结果：在意向治疗（ITT）分析（85.4% vs 76.7%, p = 0.008）、改进ITT分析（90.7% vs 84.8%, p = 0.036）和按方案（PP）分析（91.1% vs 85.5%, p = 0.047）的根除率方面，10天VA方案优于14天EA方案。三个分析的非劣效性p值均小于0.001。两组不良事件发生率比较，差异无统计学意义（9.1% vs 11.7%, p = 0.308）。与14天EA方案相比，10天VA方案的依从性更高（p = 0.006）。结论：与14天EA双药作为一线根治相比，10天VA双药治愈率为91.1% （PP分析），安全性好，依从性好。试验注册：本试验已于2023年4月12日在中国临床试验注册中心注册（注册号：ChiCTR2300070475）。
Ten-day vonoprazan-amoxicillin dual therapy versus 14-day esomeprazole-amoxicillin dual therapy for first-line Helicobacter pylori eradication: a prospective multicenter randomized controlled trial.
Background: The efficacy of the 14-day esomeprazole-amoxicillin (EA) dual therapy in eradicating Helicobacter pylori (H. pylori) has been widely discussed previously. Vonoprazan, a novel potassium-competitive acid blocker, presents rapid, potent, and long-lasting acid inhibitory effects compared to esomeprazole. However, there is currently a scarcity of direct comparisons between the 10-day vonoprazan-amoxicillin (VA) and the 14-day EA dual therapy for H. pylori eradication.
Objectives: This study aimed to compare the efficacy and safety of the 10-day VA and the 14-day EA dual therapy for H. pylori first-line eradication.
Design: This study was a prospective, multicenter, open-label, randomized controlled trial.
Methods: The study was conducted at 10 hospitals in China. In total, 570 newly diagnosed H. pylori-infected patients were recruited from April 2023 to February 2024. These patients were randomly assigned to either the 10-day VA group (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily) or the 14-day EA group (esomeprazole 20 mg four times daily + amoxicillin 750 mg four times daily). The primary outcome was the eradication rate, with secondary outcomes including adverse events and compliance.
Results: The 10-day VA regimen outperformed the 14-day EA regimen in terms of eradication rates in intention-to-treat (ITT) analysis (85.4% vs 76.7%, p = 0.008), modified ITT analysis (90.7% vs 84.8%, p = 0.036), and per-protocol (PP) analysis (91.1% versus 85.5%, p = 0.047). The non-inferiority p-values in all three analyses were less than 0.001. No statistically significant difference was observed in the incidence of adverse events between the two groups (9.1% vs 11.7%, p = 0.308). The 10-day VA regimen demonstrated higher compliance compared to the 14-day EA regimen (p = 0.006).
Conclusion: The 10-day VA dual therapy showed a satisfactory eradication rate of 91.1% (PP analysis), demonstrating good safety and better compliance compared to the 14-day EA dual therapy as the first-line eradication.
Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2300070475) on April 12, 2023.
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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