Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
Helicobacter. 2020 Dec;25(6):e12762. doi: 10.1111/hel.12762. Epub 2020 Oct 11.
Favorable outcomes in treating H pylori infection using "dual therapy (proton pump inhibitor and amoxicillin four times daily)" have attracted widespread attention. However, there are few reports, and the study results lack agreement. This study aimed to compare the eradication rate, safety, and compliance of naïve-treatment patients with H pylori infection on "dual therapy" with those on "triple plus bismuth (TPB) therapy."
This is a non-inferior randomized controlled trial conducted on 760 patients with H pylori infection. The participants were randomly assigned to two eradication groups: dual therapy (esomeprazole 20 mg and amoxicillin 750 mg four times daily) and TPB therapy (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg twice daily) for 14 days. Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed about 8 weeks after eradication to evaluate outcome. Antibiotic resistance and CYP2C19 polymorphism were determined.
Compared with TPB therapy, dual therapy had significantly higher eradication rates in intention-to-treat (87.1% vs 80.5%, rate difference 6.6%), modified intention-to-treat (90.9% vs 85.5%, 5.5%) and per-protocol (92.4% vs 87.8%, 4.7%) analyses, respectively. Adverse reactions in dual therapy group were significantly lower than TPB therapy group (17.6% vs 25.5%, P = .008), and dual therapy group had better compliance (96.3% vs 92.3%, P = .019). Antibiotic resistance and poor compliance were also associated with treatment failure.
Dual therapy (esomeprazole and amoxicillin four times daily) was non-inferior to, and even superior to TPB therapy as first-line H pylori eradication.
“双重疗法（质子泵抑制剂和阿莫西林每日 4 次）”治疗 Hpylori 感染的良好结果引起了广泛关注。然而，相关报道较少，研究结果也不一致。本研究旨在比较“双重疗法”和“三联加铋（TPB）疗法”对初治 Hpylori 感染患者的根除率、安全性和依从性。
这是一项针对 760 例 Hpylori 感染患者的非劣效性随机对照试验。参与者被随机分配到两组根除组：双重疗法（埃索美拉唑 20mg 和阿莫西林 750mg，每日 4 次）和 TPB 疗法（埃索美拉唑 20mg、阿莫西林 1000mg、克拉霉素 500mg 和枸橼酸铋钾 220mg，每日 2 次），疗程 14 天。在根除后 3 天内评估安全性和依从性。根除后约 8 周进行尿素呼气试验以评估结果。测定抗生素耐药性和 CYP2C19 多态性。
与 TPB 疗法相比，双重疗法在意向治疗（87.1% vs 80.5%，差异率 6.6%）、改良意向治疗（90.9% vs 85.5%，5.5%）和方案治疗（92.4% vs 87.8%，4.7%）分析中，根除率均显著较高。双重疗法组的不良反应发生率明显低于 TPB 疗法组（17.6% vs 25.5%，P=0.008），且双重疗法组的依从性更好（96.3% vs 92.3%，P=0.019）。抗生素耐药性和依从性差也与治疗失败有关。
双重疗法（埃索美拉唑和阿莫西林每日 4 次）作为 Hpylori 感染的一线根除方案，不劣于甚至优于 TPB 疗法。
