Comparison of tegoprazan-based high-dose dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a prospective, multicentre, randomised controlled trial in Gansu Province, a high-resistance region of China

作者：Jinxia Yang, Xiuhong Zhang, Lihong Yang, Ronghua Wu, Hong Fan, Nian Xie, Liping Gao, Yuehan Dong, Baoyuan Xie, Yuanyuan Wang, Xinglan Chen, Yi Yu, Dekui Zhang · 发表于：Therapeutic Advances in Gastroenterology · 年份：2025 · DOI：10.1177/17562848251391276 · 被引用次数：5 · 研究领域：Helicobacter pylori-related gastroenterology studies、Microscopic Colitis、Clostridium difficile and Clostridium perfringens research

Background: Potassium-competitive acid blocker-based regimens, such as tegoprazan, have demonstrated promising efficacy for Helicobacter pylori eradication. In regions with high antibiotic resistance, such as Gansu Province, bismuth-containing quadruple therapy (BQT) remains the recommended first-line treatment. However, evidence on the efficacy and safety of high-dose tegoprazan–amoxicillin dual therapy (TA) remains limited. Objectives: To compare the eradication rates and safety profiles of TA and BQT. Design: Prospective, multicentre, randomised controlled trial. Methods: Patients were enrolled from 10 centres across Gansu Province, China, between September and December 2024. Participants were randomised 1:1 to receive either BQT (esomeprazole 20 mg twice daily + bismuth potassium citrate 600 mg twice daily + amoxicillin 1000 mg twice daily + metronidazole 400 mg four times daily) or TA (tegoprazan 50 mg twice daily + amoxicillin 750 mg four times daily) for 14 days. The primary outcome was eradication rate. Secondary outcomes included adverse event (AE) rates, treatment compliance and cost-effectiveness. Results: A total of 288 patients were randomised, with baseline characteristics well balanced between the TA and BQT groups ( p > 0.05). Eradication rates for TA versus BQT were 68.06% (98/144) versus 81.25% (117/144) (difference, −13.19%; 95% confidence interval (CI): −22.95 to −3.43; p = 0.009; non-inferiority p = 0.736) in the intention-to-treat analysis; 69.01% (98...