沃克三联疗法根除幽门螺杆菌的疗效与安全性：一项多中心、前瞻性、随机对照试验
Efficacy and safety of triple therapy with vonoprazan for eradication: A multicenter, prospective, randomized controlled trial.
作者信息
Han Rong-Shuang, Hao Jing-Wen, Wang Tong, Xin Zhi, Fan Guang-Xue, Wang Guo-Dong, Liu Miao-Miao, Liu Cheng-Xia, Yang Qiu-Zi, Yang Zheng-Wu, Lv Xiao-Yan, Zhang Chao, Bian Gang, Meng Jing, Cui Zhen-Qin, Yun Xiao-Jing, Cao Jian-Hua, Li Shu-Hui, Fan Jia-Feng, Ma Hong-Gang, Gao Feng-Yu, Mao Tao, Tian Zi-Bin, Song Xiao-Hui, Yu Ya-Nan
机构信息
Department of Gastroenterology, The Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China.
Department of Epidemiology and Health Statistics, Qingdao University, Qingdao 266071, Shandong Province, China.
出版信息
World J Gastroenterol. 2025 Jul 28;31(28):109001. doi: 10.3748/wjg.v31.i28.109001.
BACKGROUND
() is a Gram-negative bacterium that relies on flagellar motility to colonize the stomach, damaging the gastric mucosa through various mechanisms and leading to various digestive disorders. Accurate assessment and precise treatment are essential in initial intensive therapy.
AIM
To investigate the efficacy and safety of a vonoprazan (VPZ)-based triple regimen for first-line eradication of in China.
METHODS
This multicenter noninferior randomized controlled trial (June 2022 to November 2023) involved 524 -positive patients across 19 centers in Shandong, China. Participants were randomized to 14-day esomeprazole/bismuth/amoxicillin/clarithromycin (EBAC), 14-day VPZ/amoxicillin/clarithromycin (VACa), or 10-day VPZ/amoxicillin/clarithromycin (VACb) - all administered twice daily. Primary outcomes (eradication rates) were assessed intention-to-treat (ITT) and per-protocol (PP) analyses. Secondary endpoints included adverse events and adherence. Noninferiority testing and tests were used for statistical comparisons.
RESULTS
A total of 524 patients participated in this study. In ITT analysis, the eradication rates of the EBAC, VACa, and VACb groups were 72.6% (127/175), 88.0% (154/175), and 83.3% (145/174), respectively ( = 0.001). The difference in the eradication rate between the EBAC and VPCa groups was 15.4% [95% confidence interval (CI): 7.3-23.6, < 0.001], and that between the EBAC and VACb groups was 10.8% (95%CI: 2.1-19.4, = 0.018). In PP analysis, the eradication rates of the EBAC, VACa, and VACb groups were 81.4% (127/156), 93.9% (154/164), and 90.6% (145/160), respectively ( = 0.001). There was no significant difference in the incidence of adverse reactions among the three groups, which were 36.6%, 33.8% and 29.6%, respectively ( = 0.50).
CONCLUSION
VPZ-based triple therapies demonstrate noninferiority to 14-day bismuth-containing regimens, with the 10-day regimen showing comparable efficacy and similar adverse event rates.
背景
（某种细菌名称未给出）是一种革兰氏阴性菌，依靠鞭毛运动在胃部定植，通过多种机制损害胃黏膜，导致各种消化系统疾病。在初始强化治疗中，准确评估和精准治疗至关重要。
目的
在中国研究基于沃克（VPZ）的三联疗法一线根除（该细菌）的疗效和安全性。
方法
这项多中心非劣效随机对照试验（2022年6月至2023年11月）纳入了中国山东19个中心的524例（该细菌）阳性患者。参与者被随机分为接受14天的埃索美拉唑/铋剂/阿莫西林/克拉霉素（EBAC）、14天的沃克/阿莫西林/克拉霉素（VACa）或10天的沃克/阿莫西林/克拉霉素（VACb）治疗——均为每日两次给药。主要结局（根除率）采用意向性分析（ITT）和符合方案分析（PP）进行评估。次要终点包括不良事件和依从性。采用非劣效性检验和（其他统计检验名称未给出）检验进行统计比较。
结果
共有524例患者参与本研究。在ITT分析中，EBAC、VACa和VACb组的根除率分别为[具体数字可能有误，应为]72.6%（127/175）、88.0%（154/175）和83.3%（145/174）（P = 0.001）。EBAC组和VPCa组之间根除率的差异为15.4%[95%置信区间（CI）：7.3 - 23.6，P < 0.001]，EBAC组和VACb组之间的差异为10.8%（95%CI：2.1 - 19.4，P = 0.018）。在PP分析中，EBAC、VACa和VACb组的根除率分别为81.4%（127/156）、93.9%（154/164）和90.6%（145/160）（P = [具体数字可能有误，应为]0.001）。三组之间不良反应的发生率无显著差异，分别为36.6%、33.8%和29.6%（P = 0.50）。
结论
基于沃克的三联疗法显示出不劣于14天含铋剂方案，10天方案显示出相当的疗效和相似的不良事件发生率。
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