Comparing high-dose dual therapy with bismuth-containing quadruple therapy for the initial eradication of Helicobacter pylori infection on Hainan Island: A randomized, multicenter clinical trial

埃索美拉唑 医学 阿莫西林 幽门螺杆菌 内科学 克拉霉素 胃肠病学 不利影响 尿素呼气试验 随机对照试验 呼吸试验 意向治疗分析 抗生素 幽门螺杆菌感染 生物 微生物学
作者
Dan‐Ni Liu,Qiuyan Wang,Peiyuan Li,Donghan Wu,Jing Pan,Zhengyi Chen,Yanqiang Li,Xiang-Yang Han,Lan Cheng,Jing Tang,Yan Tan,Cui-Yi Mo,Weizhong Yang,Jun-Ling Han,Xiaoxi Huang
出处
期刊:Clinics and Research in Hepatology and Gastroenterology [Elsevier BV]
卷期号:47 (5): 102125-102125 被引量:6
标识
DOI:10.1016/j.clinre.2023.102125
摘要

Traditional bismuth-containing quadruple therapy, as a first-line eradication treatment for Helicobacter pylori (H. pylori), has several disadvantages, including drug side effects, low medication adherence, and high costs. Trials of high-dose dual treatment have demonstrated its advantages, which include good safety and adherence profiles. In this study, we investigated the efficacy, safety, and compliance of a high-dose dual therapy when compared with bismuth-based quadruple treatment for the initial eradication of H. pylori infection on Hainan Island, China. We randomized 846 H. pylori-infected patients into two groups. A bismuth-containing quadruple therapy group was administered the following: esomeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg twice daily, and colloidal bismuth pectin in suspension 150 mg three times/day for 2 weeks. A high-dose dual therapy group was administered the following: esomeprazole 20 mg four times/day and amoxicillin 1000 mg three times/day for 2 weeks. Patients were given a 13C urea breath test at 4 weeks at treatment end. Adverse effects and compliance were evaluated at follow-up visits. Eradication rates in the high-dose dual therapy group were: 90.3% (381/422, 95% confidence interval [CI]: 87.1%–92.9%) in intention-to-treat (ITT) and 93.6% (381/407, 95% CI: 90.8%–95.8%) in per-protocol (PP) analyses. Eradication rates were 87.3% in ITT (370/424, 95% CI: 83.7%–90.3%) and 91.8% in PP analyses (370/403, 95% CI: 88.7%–94.3%) for quadruple therapy, with no statistical differences (P = 0.164 in ITT and P = 0.324 in PP analyses). Adverse effects were 13.5% (55/407) in the dual group and 17.4% (70/403) in the quadruple group (P = 0.129). Compliance was 92.4% (376/407) in the dual group and 86.6% (349/403) in the quadruple group (P = 0.007). High-dose dual therapy had high eradication rates comparable with bismuth-based quadruple treatment, with no differences in adverse effects, however higher adherence rates were recorded.
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