与经验性含铋四联疗法相比，沃克帕唑-米诺环素联合疗法作为感染的一线治疗方法。

Vonoprazan-minocycline dual therapy as a first-line treatment of infection compared with empirical bismuth-containing quadruple therapy.

作者信息

Li Meng, Wang Xiaolei, Dong Xinhong, Teng Guigen, Dai Yun, Wang Weihong

机构信息

Department of Gastroenterology, Peking University First Hospital, Beijing, China.

Department of Gastroenterology, Peking University First Hospital, No. 8 Xishiku Street, Beijing 100034, China.

出版信息

Therap Adv Gastroenterol. 2025 Aug 22;18:17562848251366156. doi: 10.1177/17562848251366156. eCollection 2025.

DOI:10.1177/17562848251366156

PMID:40860932

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12374092/

Abstract

BACKGROUND

Increasing antibiotic resistance compromises therapeutic options for () infection, especially in penicillin-allergic individuals.

OBJECTIVES

This trial aimed to assess the efficacy and safety of 14-day vonoprazan-minocycline (VM) dual therapy against bismuth-containing quadruple therapy (B-quadruple therapy), as initial treatment for infection.

DESIGN

This study was a single-center, open-label, and non-inferiority randomized controlled trial.

METHODS

In this study, 240 individuals with infection who have not received therapy were randomly assigned 1:1 to either the VM dual therapy group (vonoprazan 20 mg plus minocycline 100 mg, administered twice daily) or the B-quadruple therapy group (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all administered twice daily). The primary outcome was to evaluate the non-inferiority of eradication rates between the two groups. Secondary outcomes included assessments of AEs and compliance.

RESULTS

The eradication rates of VM dual group and B-quadruple therapy group were 87.5% and 88.3%, respectively, by intention-to-treat (ITT) analysis; 92.1% and 94.6% by modified ITT (mITT) analysis; and 92.0% and 95.5% by per-protocol (PP) analysis. The eradication rates of the VM group were non-inferior to those of the B-quadruple therapy group in ITT, mITT, and PP analyses (one-sided -values were 0.02, 0.01, and 0.02). The incidence of AEs was higher in the B-quadruple therapy group (28.3%) than in the VM group (16.7%, = 0.03). Good compliance was achieved in both groups ( = 0.60).

CONCLUSION

The VM dual therapy was not inferior to the B-quadruple therapy in the initial treatment of infection, and the incidence of AEs was lower compared to B-quadruple therapy.

TRIAL REGISTRATION

This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2400081461.

摘要

背景

抗生素耐药性不断增加，影响了（）感染的治疗选择，尤其是在对青霉素过敏的个体中。

目的

本试验旨在评估14天伏诺拉生-米诺环素（VM）双联疗法对比含铋四联疗法（B-四联疗法）作为（）感染初始治疗的疗效和安全性。

设计

本研究为单中心、开放标签、非劣效性随机对照试验。

方法

本研究中，240例未接受过治疗的（）感染患者按1:1随机分为VM双联疗法组（伏诺拉生20mg加米诺环素100mg，每日两次给药）或B-四联疗法组（雷贝拉唑10mg、阿莫西林1000mg、克拉霉素500mg和枸橼酸铋钾220mg，均每日两次给药）。主要结局是评估两组根除率的非劣效性。次要结局包括不良事件（AE）和依从性评估。

结果

意向性分析（ITT）显示，VM双联疗法组和B-四联疗法组的根除率分别为87.5%和88.3%；改良意向性分析（mITT）显示分别为92.1%和94.6%；符合方案分析（PP）显示分别为92.0%和95.5%。在ITT、mITT和PP分析中，VM组的根除率不劣于B-四联疗法组（单侧P值分别为0.02、0.01和0.02）。B-四联疗法组的AE发生率（28.3%）高于VM组（16.7%，P = 0.03）。两组均实现了良好的依从性（P = 0.60）。