Efficacy and safety of vonoprazan-amoxicillin dual therapy for Helicobacter pylori first-line treatment: a single-center, randomized, controlled trial.

IF 4.2 3区医学

Therapeutic Advances in Gastroenterology Pub Date : 2023-01-01 DOI:10.1177/17562848231190976

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

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引用次数: 2

Abstract

Background: With the increase in antibiotic resistance, the success rate of Helicobacter pylori (H. pylori) eradication therapy has declined in recent years. Vonoprazan-amoxicillin (VA) dual therapy has been reported to be a promising regimen.

Objectives: To compare the efficacy and safety of VA dual therapy and bismuth quadruple therapy containing amoxicillin and clarithromycin for H. pylori first-line eradication, and to further analyze the effects of clarithromycin resistance on eradication rate.

Design: This study was a single-center, open-label, randomized controlled trial.

Methods: Treatment-naïve H. pylori-infected patients were randomly allocated 1:1 to the VA group (vonoprazan 20 mg twice daily and amoxicillin 750 mg four times daily, for 14 days) or the RBAC group (rabeprazole 10 mg, bismuth potassium citrate 220 mg, amoxicillin 1000 mg and clarithromycin 500 mg twice daily, for 14 days). H. pylori clarithromycin resistance and CYP2C19 gene polymorphisms were detected with real-time polymerase chain reaction (PCR) technique. The eradication rates and adverse events were analyzed.

Results: A total of 151 patients were enrolled. The intention-to-treat (ITT), modified intention-to-treat (mITT), and per-protocol (PP) eradication rates and their 95% confidence intervals (95% CIs) were 94.6% (86.0-98.3%), 98.6% (91.3-99.9%), and 98.5% (90.9-99.9%) for VA group and 87.0% (77.0-93.3%), 91.8% (82.3-96.6%), and 93% (83.7-97.4%) for RBAC group. The eradication rate of the VA group was noninferior to the RBAC group in ITT, mITT, and PP analyses (p < 0.0001). In patients infected with strains of clarithromycin resistance point mutation, the eradication rate of the RBAC group decreased to lower than 90%, but the difference from the VA group did not achieve statistical significance (ITT eradication rate: 81.5% in the RBAC group and 96.2% in the VA group, p = 0.192). The incidence of adverse events in the VA group was 39.2%, which was significantly lower than that in the RBAC group (79.2%, p = 0.000).

Conclusion: The efficacy of VA dual therapy is noninferior to RBAC in H. pylori first-line eradication, with fewer adverse reactions.

Registration: This study was registered at the Chinese Clinical Trial Registry (ChiCTR2100052550) on 30 October 2021.

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伏诺哌扎-阿莫西林双重治疗幽门螺杆菌一线治疗的疗效和安全性:一项单中心、随机对照试验

背景:随着抗生素耐药性的增加，近年来幽门螺杆菌根除治疗的成功率有所下降。Vonoprazan-amoxicillin (VA)双重治疗是一种很有前景的治疗方案。目的:比较阿莫西林与克拉霉素联合使用VA双重疗法与铋四联疗法一线根除幽门螺杆菌的疗效和安全性，并进一步分析克拉霉素耐药对根除率的影响。设计:本研究为单中心、开放标签、随机对照试验。方法:Treatment-naïve将幽门幽门杆菌感染患者按1:1随机分为VA组(伏诺哌嗪20 mg，每日2次，阿莫西林750 mg，每日4次，连续14天)或RBAC组(雷贝拉唑10 mg，柠檬酸铋钾220 mg，阿莫西林1000 mg，克拉霉素500 mg，每日2次，连续14天)。采用实时聚合酶链反应(real-time polymerase chain reaction, PCR)技术检测幽门螺杆菌耐药性及CYP2C19基因多态性。分析根除率和不良事件。结果:共入组151例患者。VA组意向治疗(ITT)、改良意向治疗(mITT)和方案根除率(PP)及其95%置信区间(95% ci)分别为94.6%(86.0-98.3%)、98.6%(91.3-99.9%)和98.5% (90.9-99.9%)，RBAC组为87.0%(77.0-93.3%)、91.8%(82.3-96.6%)和93%(83.7-97.4%)。在ITT、mITT和PP分析中，VA组的根除率不低于RBAC组(p p = 0.192)。VA组不良事件发生率为39.2%，显著低于RBAC组(79.2%，p = 0.000)。结论:VA双药治疗幽门螺杆菌一线根除效果不逊于RBAC，且不良反应少。注册:本研究于2021年10月30日在中国临床试验注册中心注册(ChiCTR2100052550)。

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来源期刊

Therapeutic Advances in Gastroenterology Medicine-Gastroenterology

自引率

2.40%

发文量

103

期刊介绍： Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area. The editors welcome original research articles across all areas of gastroenterology and hepatology. The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.