Efficacy and Safety of Vonoprazan-Based Dual Therapies With Different Antibiotics Versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Prospective, Four-Arm, Randomized Controlled Trial.

IF 4.6 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2026-05-01 DOI:10.1111/hel.70132

Jie Li, Deng-Hua Li, Qi-Qi Guo, Ju Zhang, Xiao-Jing Zhu, Yu-Hao Liu, Yan-Peng Zhang, Min Chen, Yong-Quan Shi

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引用次数: 0

Abstract

Background: Vonoprazan-based dual therapy has been proposed as a simplified strategy for Helicobacter pylori eradication, but head-to-head comparisons of different antibiotic partners are limited. We compared the efficacy, safety, and adherence of vonoprazan-based dual regimens with those of bismuth-containing quadruple therapy (BQT).

Methods: In this randomized controlled trial, H. pylori-infected patients were allocated (1:1:1:1) to receive VA (vonoprazan [20 mg, bid] plus amoxicillin [1000 mg, tid]), VT (vonoprazan [20 mg, bid] plus tetracycline [500 mg, tid]), VM (vonoprazan [20 mg, bid] plus minocycline [100 mg, bid]), or VACB (vonoprazan [20 mg, bid], amoxicillin [1000 mg, bid], clarithromycin [500 mg, bid], and bismuth [220 mg, bid]) for 14 days. The primary endpoint was the H. pylori eradication rate, and the secondary endpoints were the incidence of adverse events and patient adherence.

Results: The ITT eradication rates were 83.0% (83/100), 74.0% (74/100), 82.0% (82/100), and 83.0% (83/100) in the VA, VT, VM, and VACB groups, respectively (p = 0.304). The PP eradication rates were 90.2% (83/92), 83.1% (74/89), 88.2% (82/93), and 92.2% (83/90), respectively (p = 0.262). Adverse events occurred in 21.5% of the patients overall and differed across groups (10.0%, 15.0%, 29.0%, and 32.0% in VA, VT, VM, and VACB, respectively; p < 0.001); nausea and dizziness were more frequent with VM, whereas bitter taste and black stool were more frequent with VACB. All adverse events were mild or moderate, and no severe events were recorded. Adherence was high and comparable across groups (VA 100.0%, VT 96.0%, VM 99.0%, VACB 99.0%; p = 0.107).

Conclusion: Vonoprazan-based regimens showed no statistically significant between-group differences in eradication and were associated with good adherence overall. In our setting, VA and VM may represent practical simplified options, whereas VT appeared less robust as an empiric regimen. These exploratory findings warrant confirmation in larger, adequately powered randomized trials.

Trial registration: ClinicalTrials.gov (NCT07068607).

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以vonoprazan为基础的不同抗生素双重治疗与含铋四联治疗根除幽门螺杆菌的疗效和安全性：一项前瞻性、四组、随机对照试验

背景：以vonoprazan为基础的双重治疗已被提出作为幽门螺杆菌根除的简化策略，但不同抗生素伙伴的正面比较有限。我们比较了以vonoprazan为基础的双重治疗方案与含铋四联治疗（BQT）的有效性、安全性和依从性。方法：在该随机对照试验中，幽门螺旋杆菌感染患者按1:1:1:1的比例接受VA（伏诺哌赞[20mg， bid] +阿莫西林[1000mg， bid]）、VT（伏诺哌赞[20mg， bid] +四环素[500mg， bid]）、VM（伏诺哌赞[20mg， bid] +米诺环素[100mg， bid]）或VACB（伏诺哌赞[20mg， bid]、阿莫西林[1000mg， bid]、克拉霉素[500mg， bid]、铋[220 mg， bid]）治疗14天。主要终点是幽门螺杆菌根除率，次要终点是不良事件发生率和患者依从性。结果：VA、VT、VM、VACB组ITT根除率分别为83.0%（83/100）、74.0%（74/100）、82.0%（82/100）、83.0% (83/100)（p = 0.304）。PP根除率分别为90.2%（83/92）、83.1%（74/89）、88.2%（82/93）和92.2% (83/90)（p = 0.262）。不良事件发生率为21.5%，组间存在差异（VA、VT、VM和VACB不良事件发生率分别为10.0%、15.0%、29.0%和32.0%）。结论：以vonoprazan为基础的方案在根除方面组间差异无统计学意义，总体上具有良好的依从性。在我们的设置中，VA和VM可能代表了实际的简化选择，而VT作为经验方案似乎不那么稳健。这些探索性的发现值得在更大的、足够有力的随机试验中得到证实。试验注册：ClinicalTrials.gov （NCT07068607）。

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.