Optimizing Duration and Dosing Frequency of Vonoprazan–Amoxicillin Dual Therapy for Helicobacter pylori: A Multicenter Randomized Trial

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-08-13 DOI:10.1111/hel.70062

Lulong Tao, Haisheng Qian, Leyao Zhang, Peipei Luo, Shijie Ma, Jin Yan, Yajun Liu, Meihong Chen, Yuwen Tao, Jinjin Shi, Guoxin Zhang, Feng Ye

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引用次数: 0

Abstract

Background

A 10 day vonoprazan–amoxicillin (VA) regimen (amoxicillin 750 mg four times daily) achieved > 90% Helicobacter pylori (H. pylori) eradication rates in the initial treatment. Whether less frequent dosing or shorter duration provides comparable efficacy remains unclear. This study aimed to evaluate the efficacy of simplified 7 or 10-day VA regimens to determine the optimal first-line strategy.

Methods

In this multicenter, randomized, open-label, non-inferiority trial, treatment-naive H. pylori-positive patients were randomly assigned (1:1:1:1) to four treatment groups: VA-T7 (amoxicillin 1000 mg three times daily for 7 days), VA-Q7 (amoxicillin 750 mg four times daily for 7 days), VA-T10 (amoxicillin 1000 mg three times daily for 10 days), and VA-Q10 (amoxicillin 750 mg four times daily for 10 days). All the patients received vonoprazan 20 mg twice daily. The primary outcome was the eradication rate. The secondary outcomes included adverse events and adherence.

Results

A total of 500 patients were enrolled. The eradication rates of the VA-T7, VA-Q7, VA-T10, and VA-Q10 groups were 84.0%, 81.6%, 91.2%, and 90.4% by intention-to-treat (ITT) analysis; 86.8%, 83.6%, 92.7%, and 92.6% by modified intention-to-treat (mITT) analysis; 88.2%, 85.7%, 93.4%, and 94.1% by per-protocol (PP) analysis, respectively. The efficacy of VA-T10 was non-inferior to that of VA-Q10 (p = 0.002; p = 0.001; p = 0.002 in the ITT, mITT and PP analyses, respectively). Both 7-day regimens failed to meet the non-inferiority margin of −10%. No significant effect of dosing frequency on eradication rates was observed. Adverse events and adherence were comparable among the groups.

Conclusions

The VA-T10 regimen is effective, well-tolerated, and suitable for first-line H. pylori eradication, whereas 7-day regimens are not recommended due to eradication rates < 90%.

Trial Registration

ClinicalTrials.gov identifier: ChiCTR2400079754 (www.chictr.org.cn)

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vonoprazan -阿莫西林双重治疗幽门螺杆菌的最佳疗程和给药频率：一项多中心随机试验

为期10天的vonoprazan-amoxicillin （VA）方案（amoxicillin 750 mg，每天4次）在初始治疗中达到了90%的幽门螺杆菌（H. pylori）根除率。较少的给药频率或较短的持续时间是否能提供相当的疗效尚不清楚。本研究旨在评估简化的7天或10天VA方案的疗效，以确定最佳一线策略。方法在这项多中心、随机、开放标签、非效性试验中，将未接受治疗的幽门幽门杆菌阳性患者随机分为4个治疗组：VA-T7（阿莫西林1000 mg每天3次，连用7天）、VA-Q7（阿莫西林750 mg每天4次，连用7天）、VA-T10（阿莫西林1000 mg每天3次，连用10天）和VA-Q10（阿莫西林750 mg每天4次，连用10天）。所有患者均给予伏诺哌赞20 mg，每日2次。主要结果是根除率。次要结局包括不良事件和依从性。结果共纳入500例患者。意向治疗（ITT）分析VA-T7、VA-Q7、VA-T10和VA-Q10组的根除率分别为84.0%、81.6%、91.2%和90.4%；改良意向治疗（mITT）分析分别为86.8%、83.6%、92.7%和92.6%；按方案（PP）分析，分别为88.2%、85.7%、93.4%和94.1%。VA-T10的疗效不逊于VA-Q10 (p = 0.002；p = 0.001；在ITT、mITT和PP分析中p = 0.002)。两种7天方案均未达到- 10%的非劣效性裕度。未观察到给药频率对根除率有显著影响。两组间不良事件和依从性具有可比性。结论VA-T10方案有效，耐受性良好，适合一线幽门螺杆菌根除，而7天方案因根除率高达90%而不推荐使用。临床试验注册：ClinicalTrials.gov标识符：ChiCTR2400079754 （www.chictr.org.cn）

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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.