Division of Gastroenterology, Department of Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan.
Division of Gastroenterology and Hepatology, Department of Internal Medicine Taipei City Hospital, Renai Branch, Taipei, Taiwan.
Am J Gastroenterol. 2023 Jul 1;118(7):1184-1195. doi: 10.14309/ajg.0000000000002255. Epub 2023 Mar 20.
The study aimed to compare the efficacies and safety of 14-day hybrid therapy, 14-day high-dose dual therapy, and 10-day bismuth quadruple therapy in the first-line treatment of Helicobacter pylori infections.
In this multicenter, open-label, randomized trial, we recruited adult H. pylori -infected patients from 9 centers in Taiwan. Subjects were randomly assigned (1:1:1) to 14-day hybrid therapy, 14-day high-dose dual therapy, or 10-day bismuth quadruple therapy. Eradication status was determined by the 13 C-urea breath test. The primary outcome was the eradication rate of H. pylori assessed in the intention-to-treat population.
Between August 1, 2018, and December 2021, 918 patients were randomly assigned in this study. The intention-to-treat eradication rates were 91.5% (280/306; 95% confidence interval [CI] 88.4%-94.6%) for 14-day hybrid therapy, 83.3% (255/306; 95% CI 87.8%-95.0%) for 14-day high-dose dual therapy, and 90.2% (276/306; 95% CI 87.8%-95.0%) for 10-day bismuth quadruple therapy. Both hybrid therapy (difference 8.2%; 95% CI 4.5%-11.9%; P = 0.002) and bismuth quadruple therapy (difference 6.9%; 95% CI 1.6%-12.2%; P = 0.012) were superior to high-dose dual therapy and were similar to one another. The frequency of adverse events was 27% (81/303) with 14-day hybrid therapy, 13% (40/305) with 14-day high-dose dual therapy, and 32% (96/303) with 10-day bismuth quadruple therapy. Patients receiving high-dose dual therapy had the fewest adverse events (both P < 0.001).
Fourteen-day hybrid therapy and 10-day bismuth quadruple therapy are more effective than 14-day high-dose dual therapy in the first-line treatment of H. pylori infection in Taiwan. However, high-dose dual therapy has fewer adverse effects than hybrid bismuth quadruple therapies.
本研究旨在比较 14 天混合疗法、14 天高剂量双联疗法和 10 天铋四联疗法在幽门螺杆菌感染一线治疗中的疗效和安全性。
这是一项多中心、开放标签、随机试验，我们从台湾的 9 个中心招募了成年幽门螺杆菌感染患者。受试者按 1:1:1 的比例随机分配至 14 天混合疗法、14 天高剂量双联疗法或 10 天铋四联疗法。通过 13 C-尿素呼气试验确定根除状态。主要结局为意向治疗人群中幽门螺杆菌的根除率。
2018 年 8 月 1 日至 2021 年 12 月期间，本研究共纳入 918 例患者。14 天混合疗法的意向治疗根除率为 91.5%（280/306；95%置信区间 88.4%-94.6%），14 天高剂量双联疗法为 83.3%（255/306；95%置信区间 87.8%-95.0%），10 天铋四联疗法为 90.2%（276/306；95%置信区间 87.8%-95.0%）。混合疗法（差异 8.2%；95%置信区间 4.5%-11.9%；P=0.002）和铋四联疗法（差异 6.9%；95%置信区间 1.6%-12.2%；P=0.012）均优于高剂量双联疗法，且二者相似。14 天混合疗法的不良反应发生率为 27%（81/303），14 天高剂量双联疗法为 13%（40/305），10 天铋四联疗法为 32%（96/303）。接受高剂量双联疗法的患者不良反应发生率最低（均 P<0.001）。
在台湾，与 14 天高剂量双联疗法相比，14 天混合疗法和 10 天铋四联疗法在幽门螺杆菌感染的一线治疗中更为有效。然而，高剂量双联疗法的不良反应发生率低于混合铋四联疗法。
