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

作者：Ben‐Gang Zhou, M. Guo, Lijuan Zhang, Zhidong Liu, Chunhua Liu, Xuefeng Li, Shaozhi Li, Peng Xiao, Bing Bao, Yaowei Ai, Yanbing Ding · 发表于：Therapeutic Advances in Gastroenterology · 年份：2024 · DOI：10.1177/17562848241309870 · 被引用次数：10 · 研究领域：Helicobacter pylori-related gastroenterology studies、Clostridium difficile and Clostridium perfringens research、Antimicrobial Resistance in Staphylococcus

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....