Efficacy and Safety of Vonoprazan-Based Dual, Triple, and Quadruple Therapies for Helicobacter pylori Eradication: A Randomized Controlled Trial

IF 4.6 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2026-03-04 DOI:10.1111/hel.70112

Jin-Yan Zhang, Ji Li, Wei-Feng Huang, Xiao-Yi Lei, Yu-Lin Huang, Gui-Hua Xu, Dong Xu

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引用次数: 0

Abstract

Background

Vonoprazan (VPZ), a potassium-competitive acid blocker, has shown promising efficacy in Helicobacter pylori (H. pylori) eradication. However, direct comparisons of VPZ-based dual therapy (V-DT), triple therapy (V-TT), and bismuth quadruple therapy (V-BQT) remain limited. This study aimed to evaluate and compare the efficacy, safety, and compliance of these three regimens as first-line treatments for H. pylori infection.

Methods

375 adults were randomized (1:1:1) to receive V-DT (VPZ 20 mg bid + amoxicillin 1 g tid for 10 days), V-TT (VPZ 20 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid for 14 days), or V-BQT (VPZ 20 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid + bismuth 240 mg bid for 10 days). The primary outcome was H. pylori eradication rate by intention-to-treat (ITT), modified ITT (mITT), and per-protocol (PP) analyses. Secondary outcomes included adverse events and compliance.

Results

Eradication rates were 92.0% (95% confidence interval [CI]: 85.8%–96.1%), 89.6% (95% CI: 82.9%–94.3%), and 88.8% (95% CI: 81.9%–93.7%) in ITT; 94.3% (95% CI: 88.5%–97.7%), 94.9% (95% CI: 89.3%–98.1%), and 94.1% (95% CI: 88.2%–97.6%) in mITT; and 94.2% (95% CI: 88.4%–97.6%), 95.6% (95% CI: 90.0%–98.5%), and 94.8% (95% CI: 89.0%–98.1%) in PP analyses for V-DT, V-TT, and V-BQT, respectively. The efficacy of V-DT and V-TT was noninferior to that of V-BQT. Adverse events were significantly lower with V-DT (6.4%) than with V-TT (36.0%) and V-BQT (49.6%) (p < 0.001). Compliance exceeded 93% in all groups, with no significant differences (p = 0.250).

Conclusions

All three regimens achieved high eradication rates, with V-DT and V-TT being statistically noninferior to V-BQT. The 10-day V-DT regimen achieved eradication rates comparable to V-BQT with substantially fewer adverse events and reduced antibiotic use, supporting its potential as a simplified first-line option for H. pylori eradication.

Trial Registration

Chinese Clinical Trial Registration Number: ChiCTR2300072857

查看原文本刊更多论文

以伏诺哌嗪为基础的双联、三联和四联治疗幽门螺杆菌根除的疗效和安全性：一项随机对照试验。

背景：Vonoprazan （VPZ）是一种钾竞争性酸阻滞剂，在根除幽门螺杆菌（h.p ylori）方面显示出良好的效果。然而，基于vpz的双重治疗（V-DT）、三联治疗（V-TT）和铋四联治疗（V-BQT）的直接比较仍然有限。本研究旨在评估和比较这三种方案作为幽门螺杆菌感染一线治疗的有效性、安全性和依从性。方法：375名成人随机（1:1:1）接受V-DT （VPZ 20 mg bid +阿莫西林1 g bid +克拉霉素500 mg bid，持续10天）、V-TT （VPZ 20 mg bid +阿莫西林1 g bid +克拉霉素500 mg bid，持续14天）或V-BQT （VPZ 20 mg bid +阿莫西林1 g bid +克拉霉素500 mg bid +铋240 mg bid，持续10天）治疗。主要终点是通过意向治疗（ITT）、修改后的ITT （mITT）和每个方案（PP）分析得出的幽门螺杆菌根除率。次要结局包括不良事件和依从性。结果：ITT的根除率分别为92.0%（95%可信区间[CI]: 85.8% ~ 96.1%）、89.6% （95% CI: 82.9% ~ 94.3%）和88.8% (95% CI: 81.9% ~ 93.7%)；94.3% (95% CI: 88.5% - -97.7%), 94.9% (95% CI: 89.3% - -98.1%)和94.1% (95% CI: 88.2% - -97.6%)手套;在V-DT、V-TT和V-BQT的PP分析中分别为94.2% （95% CI: 88.4%-97.6%）、95.6% （95% CI: 90.0%-98.5%）和94.8% （95% CI: 89.0%-98.1%）。V-DT和V-TT的疗效不逊于V-BQT。V-DT组的不良事件发生率（6.4%）明显低于V-TT组（36.0%）和V-BQT组（49.6%）(p)。结论：三种方案均获得了较高的根除率，V-DT和V-TT在统计学上不低于V-BQT组。10天的V-DT方案达到了与V-BQT相当的根除率，不良事件显著减少，抗生素使用减少，支持其作为幽门螺杆菌根除的简化一线选择的潜力。试验注册：中国临床试验注册号：ChiCTR2300072857。

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.