Is Tailored Bismuth Quadruple Therapies (With Clarithromycin or Furazolidone) Based on Fecal Molecular Susceptibility Testing in First-Line Helicobacter pylori Eradication Treatment More Effective? A Three-Arm, Multicenter Randomized Clinical Trial

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-02-09 DOI:10.1111/hel.70018

Zhengchen Yu, Xiaochen Liu, Jincheng Qiao, Wenjuan Shen, Xingwei Mao, Guochun Lou, Yan Li, Ziming Xie, Jun Ye

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引用次数: 0

Abstract

Background

Rising antimicrobial resistance has significantly challenged the eradication rates of Helicobacter pylori. Due to its invasive nature, susceptibility testing based on endoscopic biopsy is controversial, while few studies have focused on the efficacy of tailored bismuth quadruple therapies (BQT) based on fecal susceptibility testing as a first-line treatment.

Methods

In this multicenter study, 598 H. pylori-positive patients without previous eradication treatment were recruited and randomly assigned to three groups: empirical BQT, BQT-tailored based on the history of clarithromycin use and tailored based on fecal molecular susceptibility testing where furazolidone was substituted for clarithromycin when there was clinical or laboratory evidence of clarithromycin resistance. This study defines BQT as regimens comprising rabeprazole, colloidal bismuth, amoxicillin, and one additional antibiotic (furazolidone or clarithromycin). The study assessed eradication rates using intention-to-treat (ITT), modified intention-to-treat (mITT), and per-protocol (PP) analyses.

Results

The eradication rates of three groups were 82.00%, 80.90%, and 87.44% in the ITT analysis; 82.41%, 83.42%, and 89.23% in the mITT analysis; and 85.86%, 87.50%, and 94.57% in the PP analysis, respectively. Tailored BQT based on fecal susceptibility testing was not inferior to empirical BQT (all p values for noninferiority < 0.001) and demonstrated greater efficacy in the PP analysis (difference [95% CI]: 7.07% [0.90%, 13.25%]). The incidence of adverse events and treatment compliance did not differ significantly among the groups.

Conclusion

Tailored BQT based on fecal susceptibility testing is an effective regimen for H. pylori eradication, with no increase in adverse events or treatment noncompliance compared with empirical BQT. Therefore, we recommend tailored BQT based on fecal susceptibility testing as a first-line treatment.

Trial Registration

EudraCT number: NCT05718609; ClinicalTrials.gov

查看原文本刊更多论文

基于粪便分子药敏试验的定制铋四联疗法（克拉霉素或呋喃唑酮）在一线幽门螺杆菌根除治疗中更有效吗？一项三组、多中心随机临床试验

背景：不断上升的抗菌素耐药性极大地挑战了幽门螺杆菌的根除率。由于其侵入性，基于内镜活检的药敏检测存在争议，而很少有研究关注基于粪便药敏检测的定制铋四联疗法（BQT）作为一线治疗的有效性。方法在这项多中心研究中，招募598例既往未接受根除治疗的幽门螺旋杆菌阳性患者，随机分为三组：经经验BQT组、根据克拉霉素使用史量身定制的BQT组和根据粪便分子药敏试验量身定制的BQT组，当有临床或实验室证据表明克拉霉素耐药时，用呋喃唑酮代替克拉霉素。本研究将BQT定义为由雷贝拉唑、胶体铋、阿莫西林和一种附加抗生素（呋喃唑酮或克拉霉素）组成的方案。该研究使用意向治疗（ITT）、改良意向治疗（mITT）和每个方案（PP）分析来评估根除率。结果ITT分析3组的根除率分别为82.00%、80.90%和87.44%；mITT分析分别为82.41%、83.42%和89.23%；在PP分析中分别为85.86%、87.50%和94.57%。基于粪便敏感性测试的量身定制BQT并不逊于经验性BQT（所有p值均为非劣效性<； 0.001），并且在PP分析中显示出更大的疗效（差异[95% CI]: 7.07%[0.90%, 13.25%]）。组间不良事件发生率和治疗依从性无显著差异。结论基于粪便药敏试验的定制BQT是根除幽门螺杆菌的有效方案，与经验性BQT相比，不良事件和治疗不依从性没有增加。因此，我们推荐基于粪便敏感性测试的量身定制BQT作为一线治疗。试验注册稿号：NCT05718609；ClinicalTrials.gov

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.