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：Zhiqiang Song, Weihong Wang, Peng Li, Xiuli Zuo, Yin Zhu, Ye Chen, Xiaolan Zhang, Bin Lü, Rong Lin, Yiqi Du, Lan Cheng, Hao Wu, Weixing Chen, Yanqing Ye, Huizhen Fan, Aijun Liao, Honghui Chen, Chengxia Liu, Zhenyu Zhang, Wen Wang, Zhimin Suo, Xiaoan Li, Qin Du, Xing Li, Feng Pan, Jianhua Tang, Min Xu, Xiongxiang Liu, Pengyuan Zheng, Huixin Chen, Lixiao Du, Jiayin Lu, Chun Feng, Wensheng Pan, Hong Wang, Zhirong Zeng, Jinhai Wang, Shengxiang Lyu, Dunju Liu, Shiming Yang, Liangping Li, Liya Zhou · 发表于：Chinese Medical Journal · 年份：2025 · DOI：10.1097/cm9.0000000000003780 · 被引用次数：3 · 研究领域：Helicobacter pylori-related gastroenterology studies、Gastrointestinal motility and disorders、Microscopic Colitis

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 ...