Vonoprazan-Amoxicillin Dual Therapy Versus Drug Sensitivity-Based Individualized Therapy as a Rescue Regimen for Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-02-25 DOI:10.1111/hel.70009

Yu-xiang Liu, Han-ning Liu, Heng-qi Liu, Ying-ying Yang, Hong-li Cui, Li-lin Fan, Wen-jing Sun, Hao Mei, Xing-wei Wang, Guo Yan, Chun-hui Lan

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Abstract

Objective

Vonoprazan is a novel potassium-competitive acid blocker (P-CAB) that offers several advantages, such as fast onset time and strong acid inhibition, in the treatment of Helicobacter pylori infection. This study aims to evaluate the efficacy, adverse reactions, and compliance of the 14-day vonoprazan-amoxicillin dual therapy versus drug sensitivity-based individualized therapy in the retreatment of H. pylori infection.

Methods

This multicenter, open-label, randomized, controlled non-inferiority study enrolled 240 adult patients who previously failed anti-H. pylori treatment. These patients were randomly assigned to receive the 14-day vonoprazan-amoxicillin dual therapy or drug sensitivity-based individualized therapy. The primary outcome was the eradication rate, and the secondary outcomes mainly included adverse events, patient compliance, antibiotic resistance rates, and risk factors that affected the eradication rate.

Results

The intention-to-treat (ITT) and per-protocol (PP) analyses revealed that the eradication rates for the vonoprazan-amoxicillin dual therapy and drug sensitivity-based individualized therapy were comparably high, with rates of 87.50% and 83.33%, respectively. Furthermore, the vonoprazan-amoxicillin dual therapy fulfilled the criteria for the non-inferiority test, when compared to individualized therapy. The incidence of adverse reactions was significantly lower in the vonoprazan-amoxicillin dual therapy group. Both groups showed similarly good compliance and comparable rates of antibiotic resistance. The previous treatment with a clarithromycin-containing regimen was identified as an independent risk factor for clarithromycin resistance.

Conclusion

The 14-day vonoprazan-amoxicillin dual therapy exhibits high eradication rates and low incidence of adverse reactions in retreated patients, indicating its effectiveness and safety as a rescue regimen for patients with H. pylori infection.

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vonoprazan -阿莫西林双重治疗与基于药物敏感性的个体化治疗作为幽门螺杆菌感染的拯救方案：一项多中心，随机对照试验

目的Vonoprazan是一种治疗幽门螺杆菌感染的新型钾竞争性酸阻滞剂（P-CAB），具有起效时间快、抑酸作用强等优点。本研究旨在评估14天vonoprazan-amoxicillin双重治疗与基于药物敏感性的个体化治疗在幽门螺杆菌感染再治疗中的疗效、不良反应和依从性。方法：这项多中心、开放标签、随机对照、非劣效性研究纳入了240例既往抗h抗体失败的成年患者。螺杆菌治疗。这些患者被随机分配接受为期14天的vonoprazan-amoxicillin双重治疗或基于药物敏感性的个体化治疗。主要终点为根除率，次要终点主要包括不良事件、患者依从性、抗生素耐药率和影响根除率的危险因素。结果意向治疗（ITT）和方案治疗（PP）分析显示，vonoprazan-阿莫西林双重治疗和基于药物敏感性的个体化治疗的根除率均较高，分别为87.50%和83.33%。此外，与个体化治疗相比，vonoprazan-amoxicillin双重治疗符合非劣效性测试的标准。vonoprazan-amoxicillin双重治疗组的不良反应发生率明显较低。两组均表现出相似的良好依从性和相似的抗生素耐药率。先前使用含克拉霉素方案的治疗被确定为克拉霉素耐药的独立危险因素。结论vonoprazan-阿莫西林联合治疗14 d幽门螺杆菌感染患者的根除率高，不良反应发生率低，是一种有效、安全的治疗方案。

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

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.