Vonoprazan Versus Tegoprazan–Amoxicillin Dual Therapy for Treatment-Naïve Patients With Helicobacter pylori Infection: A Prospective, Multicenter, Open-Label, Randomized Controlled Study

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2026-04-01 DOI:10.1111/hel.70124

Ya-Ni Zhou, Ji-Chun Song, Qing-Hua Wang, Huang Feng, Ya Lin, De-Min Li, Ge Wang, Xiao-Wei Huang, Jing-Mei Liu, Yan Shen, Xiang Zhou, Hui-Ting Xue, Yan Liu, Pei-Yuan Li

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引用次数: 0

Abstract

Background

High-dose dual therapy (HDDT) has been shown to achieve eradication rates non-inferior to the bismuth quadruple therapy (BQT) in treatment-naïve patients of Helicobacter pylori (H. pylori) infection, with advantages including greater convenience and fewer adverse events. However, the efficacy of different potassium-competitive acid blockers (P-CABs) in HDDT regimens remains incompletely defined due to variations in their pharmacokinetic properties. Therefore, this study aims to evaluate the eradication rates, incidence of adverse events, and compliance of the dual regimens of vonoprazan/tegoprazan combined with amoxicillin in patients with treatment-naïve H. pylori infection.

Method

This prospective, multicenter, open-label, randomized controlled clinical trial enrolled newly diagnosed patients with H. pylori infection from six centers in China. All subjects were randomly assigned to the VA group (vonoprazan 20 mg bid+amoxicillin 1 g tid, 14 days) or the TA group (tegoprazan 50 mg bid+amoxicillin 1 g tid, 14 days). The basic information and clinical data of the patients were collected via electronic questionnaires, WeChat, or telephone follow-ups. H. pylori eradication was assessed 4 weeks post-treatment using the urea breath test (UBT). The adverse events and compliance were meticulously recorded throughout the treatment period.

Result

Between June 2024 and May 2025, 710 patients were randomly assigned, and 653 subjects were included. In the intention-to-treat (ITT) analysis, the eradication rates were 89.3% in the VA group and 76.1% in the TA group, respectively (p < 0.001). The modified intention-to-treat (mITT) analysis showed rates of 94.6% and 80.8%, respectively (p < 0.001), and the per-protocol (PP) analysis yielded 95.1% and 81.0%, respectively (p < 0.001). Although the overall incidence of adverse event rates was comparable between groups (17.2% vs. 13.8%, p = 0.254), gastrointestinal adverse events were less frequent with TA therapy (9.3% vs. 14.4%, p = 0.048). Compliance was excellent and comparable in both groups (94.6% vs. 94.1%, respectively, p = 0.871). None of the factors analyzed significantly influenced eradication rates.

Conclusion

Vonoprazan/amoxicillin dual therapy achieved satisfactory H. pylori eradication rates with a favorable safety profile in treatment-naïve patients. Tegoprazan/amoxicillin dual therapy was associated with fewer gastrointestinal adverse event incidences, while optimizing tegoprazan dosing frequency may be necessary to improve the eradication.

Trial Registration

Chictr.org.cn ChiCTR2400082371

查看原文本刊更多论文

伏诺哌赞与替戈拉赞-阿莫西林双重治疗Treatment-Naïve幽门螺杆菌感染患者：一项前瞻性、多中心、开放标签、随机对照研究

背景：高剂量双重治疗（HDDT）在treatment-naïve幽门螺杆菌（H. pylori）感染患者中的根除率不低于铋四联治疗（BQT），其优点包括更方便和更少的不良事件。然而，不同的钾竞争性酸阻滞剂（p - cab）在HDDT方案中的功效由于其药代动力学性质的差异仍然不完全确定。因此，本研究旨在评估vonoprazan/tegoprazan联合阿莫西林双方案对treatment-naïve幽门螺杆菌感染患者的根除率、不良事件发生率和依从性。方法：这项前瞻性、多中心、开放标签、随机对照临床试验纳入了来自中国六个中心的新诊断的幽门螺杆菌感染患者。所有受试者随机分为VA组（vonoprazan bid 20 mg +阿莫西林1 g /天，14天）或TA组（替戈拉赞bid 50 mg +阿莫西林1 g /天，14天）。通过电子问卷、微信、电话随访等方式收集患者的基本信息和临床资料。治疗后4周采用尿素呼气试验（UBT）评估幽门螺杆菌根除情况。在整个治疗期间仔细记录不良事件和依从性。结果：在2024年6月至2025年5月期间，随机分配710例患者，纳入653名受试者。在意向治疗（ITT）分析中，VA组的根除率为89.3%，TA组的根除率为76.1%。(p)结论：Vonoprazan/阿莫西林双重治疗在treatment-naïve患者中获得了令人满意的幽门螺杆菌根除率和良好的安全性。替戈拉桑/阿莫西林双重治疗与胃肠道不良事件发生率较低相关，而优化替戈拉桑给药频率可能是改善根除的必要条件。试验报名：Chictr.org.cn ChiCTR2400082371。

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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.