基于替戈拉赞与基于埃索美拉唑的三联疗法加铋剂用于一线根除幽门螺杆菌：一项全国性、多中心、双盲、双模拟、随机对照试验。

Tegoprazan-based versus esomeprazole-based triple therapy plus bismuth for first-line Helicobacter pylori eradication: A nationwide, multicenter, double-blind, double-dummy, randomized controlled trial.

作者信息

Song Zhiqiang, Wang Weihong, Li Peng, Zuo Xiuli, Zhu Yin, Chen Ye, Zhang Xiaolan, Lyu Bin, Lin Rong, Du Yiqi, Lan Cheng, Wu Hao, Chen Weixing, Ye Yanqing, Fan Huizhen, Liao Aijun, Chen Honghui, Liu Chengxia, Zhang Zhenyu, Wang Wen, Suo Zhimin, Li Xiaoan, Du Qin, Li Xing, Pan Feng, Tang Jianhua, Xu Min, Liu Xiongxiang, Zheng Pengyuan, Chen Huixin, Du Ling, Lu Jiayin, Feng Chun, Pan Wensheng, Wang Hong, Zeng Zhirong, Wang Jinhai, Lyu Shengxiang, Liu Dunju, Yang Shiming, Li Liangping, Zhou Liya

机构信息

Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China.

Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China.

出版信息

Chin Med J (Engl). 2025 Aug 22. doi: 10.1097/CM9.0000000000003780.

DOI:10.1097/CM9.0000000000003780

PMID:40846665

Abstract

BACKGROUND

Although triple therapy plus bismuth (TTPB), comprising a proton pump inhibitor (PPI), two antibiotics, and bismuth, is widely used to eradicate Helicobacter pylori (H. pylori), eradication rates have been suboptimal. Potassium-competitive acid blockers (P-CABs) offer stronger and more stable gastric acid inhibition compared to PPIs. This study aimed to compare the efficacy, safety, and compliance of tegoprazan-based TTPB (TACB) vs. esomeprazole-based TTPB (EACB) in treatment-naïve patients with H. pylori infection.

METHODS

In this nationwide, multicenter, double-blind, double-dummy, randomized controlled trial conducted from October 2022 to September 2023 across 41 centers in China, 561 eligible patients with H. pylori infection were randomized (1:1) to receive either TACB (tegoprazan 50 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth 220 mg) or EACB (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth 220 mg), all administered twice daily for 14 days. H. pylori eradication was assessed using the 13C-urea breath test at 4-8 weeks post-treatment. The primary endpoint was eradication rate based on the full analysis set (FAS). Statistical analysis included the chi-squared tests, with a predefined non-inferiority margin of -10%.

RESULTS

In the FAS population, eradication rates were 93.5% (95% confidence interval [CI]: 89.9-96.1%) in the TACB group and 86.4% (95% CI: 81.9-90.2%) in the EACB group. The between-group difference was 7.0% (95% CI: 2.1-12.0%), indicating that tegoprazan-based TTPB was non-inferior to esomeprazole-based TTPB. Furthermore, superiority tests found a significantly higher eradication rate in tegoprazan group compared with esomeprazole group (P = 0.006). Similar results were observed in the per-protocol set. The incidence of treatment-emergent adverse events was comparable between groups (75.5% in TACB vs. 73.4% in EACB), with most events being mild and transient. Compliance was high in both groups (98.4% vs. 98.8%).

CONCLUSION

TACB was non-inferior to EACB in H. pylori eradication efficacy, with similar safety and compliance profiles in Chinese treatment-naïve patients.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT05577468.

摘要

背景

尽管包含质子泵抑制剂（PPI）、两种抗生素和铋剂的三联疗法加铋剂（TTPB）被广泛用于根除幽门螺杆菌（H. pylori），但其根除率一直不尽人意。与PPI相比，钾离子竞争性酸阻滞剂（P-CABs）能提供更强、更稳定的胃酸抑制作用。本研究旨在比较基于替戈拉赞的TTPB（TACB）与基于埃索美拉唑的TTPB（EACB）在初治幽门螺杆菌感染患者中的疗效、安全性和依从性。

方法

在2022年10月至2023年9月于中国41个中心开展的这项全国性、多中心、双盲、双模拟、随机对照试验中，561例符合条件的幽门螺杆菌感染患者被随机（1:1）分为两组，分别接受TACB（替戈拉赞50毫克、阿莫西林1000毫克、克拉霉素500毫克和铋剂220毫克）或EACB（埃索美拉唑20毫克、阿莫西林1000毫克、克拉霉素500毫克和铋剂220毫克）治疗，均每日服用两次，共14天。在治疗后4-8周使用13C-尿素呼气试验评估幽门螺杆菌根除情况。主要终点是基于全分析集（FAS）的根除率。统计分析包括卡方检验，预设的非劣效界值为-10%。

结果

在FAS人群中，TACB组的根除率为93.5%（95%置信区间[CI]：89.9-96.1%），EACB组为86.4%（95%CI：81.9-90.2%）。组间差异为7.0%（95%CI：2.1-12.0%），表明基于替戈拉赞的TTPB不劣于基于埃索美拉唑的TTPB。此外，优效性检验发现替戈拉赞组的根除率显著高于埃索美拉唑组（P = 0.006）。在意向性分析集中也观察到了类似结果。两组治疗期间出现的不良事件发生率相当（TACB组为75.