Vonoprazan–Amoxicillin Dual Therapy With Different Amoxicillin Administration Regimens for Helicobacter pylori Treatment: A Randomized Controlled Trial

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2024-08-01 DOI:10.1111/hel.13118

Shuhan Qiu, Yu Huang, Jinnan Chen, Yixian Guo, Meixuan Li, Zhaohui Ding, Xiao Liang, Hong Lu

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引用次数: 0

Abstract

Background

The effect of preprandial or postprandial administration of amoxicillin on the efficacy of vonoprazan–amoxicillin dual therapy (VA-dual therapy) for Helicobacter pylori treatment has not been studied. It is also unclear whether amoxicillin dosing four times daily is more effective than three times daily. We aimed to investigate the effect of different amoxicillin administration regimens on the efficacy of VA-dual therapy.

Materials and Methods

H. pylori-infected subjects were randomly assigned to three groups in a 1:1:1 ratio to receive a 14-day dual therapy consisting of vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily before meals (BM-TID) or 1000 mg three times daily after meals (AM-TID) or 750 mg four times daily after meals (AM-QID). H. pylori eradication rates, adverse events rates, compliance, and antibiotic resistance were compared.

Results

Between May 2021 to April 2023, 327 subjects were enrolled. The eradication rates of BM-TID, AM-TID, and AM-QID dual therapy were 88.1%, 89.9%, and 93.6% in intention-to-treat (ITT) analysis, 90.6%, 94.2%, and 99.0% in modified ITT (MITT) analysis, and 90.4%, 94.1%, and 99.0% in per-protocol (PP) analysis. Although there was non-inferiority between BM-TID and AM-TID, as well as between AM-TID and AM-QID, AM-QID was significantly more effective than BM-TID. There were no significant differences in adverse event rates, compliance, and antibiotic resistance among the three groups.

Conclusions

Postprandial administration and the increased frequency of administration of amoxicillin may contribute to a better efficacy of VA-dual therapy, especially for rescue therapy. All VA-dual therapy in our study could achieve good efficacy for first-line treatment.

Trial Registration: clinicaltrials.gov: NCT05901051.

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治疗幽门螺旋杆菌的沃诺普拉赞-阿莫西林双重疗法与不同的阿莫西林给药方案：随机对照试验

背景：关于餐前或餐后服用阿莫西林对冯诺普拉唑-阿莫西林双重疗法（VA-dual therapy）治疗幽门螺杆菌疗效的影响，尚未进行研究。此外，阿莫西林每日给药四次是否比每日给药三次更有效也不清楚。我们的目的是研究不同的阿莫西林给药方案对 VA 双联疗法疗效的影响。材料和方法：幽门螺杆菌感染者按 1:1:1 的比例被随机分配到三组，接受为期 14 天的双联疗法，包括冯诺普拉赞 20 毫克，每日两次；阿莫西林 1000 毫克，每日三次，饭前服用（BM-TID）或 1000 毫克，每日三次，饭后服用（AM-TID）或 750 毫克，每日四次，饭后服用（AM-QID）。比较了幽门螺杆菌根除率、不良反应率、依从性和抗生素耐药性：结果：在 2021 年 5 月至 2023 年 4 月期间，共有 327 名受试者入组。在意向治疗（ITT）分析中，BM-TID、AM-TID和AM-QID双重疗法的根除率分别为88.1%、89.9%和93.6%；在修正ITT（MITT）分析中，根除率分别为90.6%、94.2%和99.0%；在按方案（PP）分析中，根除率分别为90.4%、94.1%和99.0%。尽管BM-TID与AM-TID之间以及AM-TID与AM-QID之间不存在劣效性，但AM-QID的疗效明显优于BM-TID。三组之间在不良事件发生率、依从性和抗生素耐药性方面没有明显差异：结论：餐后给药和增加阿莫西林的给药频率可能有助于提高 VA 双联疗法的疗效，尤其是在抢救治疗中。结论：餐后给药和增加阿莫西林给药次数可能有助于提高疗效，尤其是在抢救治疗中。我们研究中的所有 VA 双联疗法都能在一线治疗中取得良好疗效：试验注册：clinicaltrials.gov：NCT05901051。

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.