"Efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori infection: a multicenter, randomized controlled clinical trial"

作者全名："Mei, Hao; Guo, Yan; Zhao, Jing-Tao; Yang, Jun; Sun, Wen-jing; Zhang, De-kui; He, Ping; Shi, Gang; Su, Na-yun; Han, Ran; Lan, Chun-Hui"

作者地址："[Mei, Hao; Guo, Yan; Zhao, Jing-Tao; Su, Na-yun; Lan, Chun-Hui] Army Med Univ, Mil Med Univ 3, Daping Hosp, Dept Gastroenterol,Chongqing Key Lab Digest Malign, Chongqing 400042, Peoples R China; [Yang, Jun] Peoples Hosp Chongqing Banan Dist, Dept Gastroenterol, Chongqing, Peoples R China; [Sun, Wen-jing] 13th Peoples Hosp Chongqing, Dept Gastroenterol, Chongqing, Chin, Myanmar; [Zhang, De-kui] Lanzhou Univ, Dept Gastroenterol, Hosp 2, Lanzhou, Peoples R China; [He, Ping] Chongqing Med Univ, Dept Gastroenterol, Yongchuan Hosp, Chongqing, Peoples R China; [Shi, Gang] Chongqing Red Cross Hosp, Dept Gastroenterol, Chongqing, Chin, Myanmar"

通信作者："Lan, CH (通讯作者)，Army Med Univ, Mil Med Univ 3, Daping Hosp, Dept Gastroenterol,Chongqing Key Lab Digest Malign, Chongqing 400042, Peoples R China."

来源：THERAPEUTIC ADVANCES IN GASTROENTEROLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000928027500001

JCR分区：Q2

影响因子：4.2

年份：2022

卷号：15

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：Helicobacter pylori; bismuth-containing quadruple therapy; high-dose dual therapy; eradication therapy; drug-induced adverse event

摘要："Background:A high-dose proton pump inhibitor (PPI)-amoxicillin dual therapy has been investigated for treatment of patients with Helicobacter pylori (H. pylori) infection. Currently, the efficacy of this dual therapy remains inconclusive, with controversial findings from various single-center clinical trials. Objectives:To assess the efficacy and safety of high-dose dual therapy (HDDT) compared with the bismuth-containing quadruple therapy (BQT) in treatment-naive patients with H. pylori infection. Design:A multicenter, open-label, randomized controlled clinical trial. Methods:Three hundred and forty treatment-naive patients with H. pylori infection were prospectively recruited from seven participating hospitals. The enrolled patients were randomized into one of two treatment groups: the HDDT group (esomeprazole, 20 mg four times daily; amoxicillin, 750 mg four times daily) and the BQT group (esomeprazole, 20 mg, twice daily; bismuth potassium citrate, 600 mg, twice daily; amoxicillin, 1 g, twice daily; metronidazole, 400 mg, four times daily). The primary outcome was eradication rate, and secondary outcomes were safety and patient compliance. Results:The eradication rates in the HDDT group versus the BQT group were 86.47% versus 87.06% on intention-to-treat (ITT) analysis, 91.88% versus 92.50% on modified ITT (MITT) analysis, and 91.77% versus 93.04% on per-protocol (PP) analysis, with no significant differences between the two groups. The patient compliance rates in the HDDT group versus the BQT group were 97.02% versus 95.86%, and no significant difference was found between the two groups. Notably, the HDDT group exhibited significantly lower incidence in the drug-induced adverse events (AEs) compared to the BQT group (16.67% versus 47.94%). Conclusion:HDDT is equally efficacious in eradicating H. pylori infection and resulted in good patient compliance and safety compared with BQT. These findings provide evidence in support of HDDT as a first-line treatment for H. pylori infection. Registration:This clinical trial was registered at The Chinese Clinical Trial Registry (trial registration number: ChiCTR2000039096)."

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