Vonoprazan-minocycline dual therapy as a first-line treatment of Helicobacter pylori infection compared with empirical bismuth-containing quadruple therapy.

IF 3.4 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Therapeutic Advances in Gastroenterology Pub Date : 2025-08-22 eCollection Date: 2025-01-01 DOI:10.1177/17562848251366156

Meng Li, Xiaolei Wang, Xinhong Dong, Guigen Teng, Yun Dai, Weihong Wang

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引用次数: 0

Abstract

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.

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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。

背景：不断增加的抗生素耐药性影响了幽门螺杆菌（H. pylori）感染的治疗选择，特别是在青霉素过敏个体中。目的：本试验旨在评估14天vonoprazan-minocycline （VM）双重治疗对含铋四联疗法（b -四联疗法）的有效性和安全性，作为幽门螺杆菌感染的初始治疗。设计：本研究为单中心、开放标签、非劣效性随机对照试验。方法：在这项研究中，240名未接受治疗的幽门螺杆菌感染患者被随机按1:1分配到VM双重治疗组（伏诺哌赞20 mg加米诺环素100 mg，每日两次）或b -四联治疗组（雷巴拉唑10 mg，阿莫西林1000 mg，克拉霉素500 mg，柠檬酸铋钾220 mg，均每日两次）。主要结局是评估两组间根除率的非劣效性。次要结局包括ae和依从性评估。结果：意向治疗（ITT）分析，VM双药组和b四药组的根除率分别为87.5%和88.3%；修正ITT （mITT）分析分别为92.1%和94.6%；PP分析为92.0%和95.5%。在ITT、mITT和PP分析中，VM组的根除率不低于b -四联治疗组（单侧p值分别为0.02、0.01和0.02）。b -四联治疗组ae发生率（28.3%）高于VM组（16.7%,p = 0.03）。两组患者均有良好的依从性（p = 0.60）。结论：VM双药治疗幽门螺杆菌感染的初始治疗效果不逊于b -四联治疗，ae发生率低于b -四联治疗。试验注册：本试验已在中国临床试验注册中心注册，注册号为ChiCTR2400081461。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapeutic Advances in Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

6.70

自引率

2.40%

发文量

103

审稿时长

15 weeks

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.