Chen Li-Wei, Chang Liang-Che, Hua Chung-Ching, Liu Ching-Jung, Chou Tien-Shin, Lin Chih-Lang, Chien Rong-Nan
Department of Gastroenterology and Hepatology, Chang-Gung Memorial Hospital and University, Keelung Branch, Keelung 20401, Taiwan.
Community Medicine Research Center, Chang-Gung Memorial Hospital and University, Keelung Branch, Keelung 20401, Taiwan.
J Clin Med. 2021 Sep 24;10(19):4352. doi: 10.3390/jcm10194352.
This was a prospective, randomized, open-label trial. Patients without previous eradication therapy were randomly assigned to either a high-dose dual therapy (HDDT) group or a traditional clarithromycin/amoxicillin triple therapy (CATT) group. In the HDDT group, patients took rabeprazole, 20 mg, four times per day for three days and then dual therapy with rabeprazole, 20 mg, and amoxicillin, 500 mg, four times per day during the patient's breakfast, lunch, dinner, and bedtime for 14 days. In the CATT group, patients received conventional triple therapy for 14 days (rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice per day). In the HDDT group, the success rates of eradication were 91.7% (95% confidence interval (CI): 0.78-0.97) by intention-to-treat (ITT) and 94.3% (95% CI: 0.79-0.99) by per-protocol (PP) analysis. In the CATT group, the eradication rates were 77.1% (95% CI: 0.61-0.87) by ITT and 84.3% (95% CI: 0.66-0.94) by PP analysis. The study completion rates were 97.2% (35/36) in the HDDT group. Three-day high-dose rabeprazole induction treatment before dual therapy and a schedule of taking the drug at meal and bed times could achieve an acceptable eradication rate (>90%) and good drug compliance.
这是一项前瞻性、随机、开放标签试验。未曾接受过根除治疗的患者被随机分配至高剂量双联疗法（HDDT）组或传统克拉霉素/阿莫西林三联疗法（CATT）组。在HDDT组中，患者每天服用4次20毫克雷贝拉唑，持续3天，然后在患者早餐、午餐、晚餐和就寝时间每天服用4次20毫克雷贝拉唑和500毫克阿莫西林，持续14天。在CATT组中，患者接受传统三联疗法14天（雷贝拉唑20毫克、阿莫西林1克和克拉霉素500毫克，每天2次）。在HDDT组中，意向性分析（ITT）的根除成功率为91.7%（95%置信区间（CI）：0.78 - 0.97），符合方案分析（PP）为94.3%（95% CI：0.79 - 0.99）。在CATT组中，ITT的根除率为77.1%（95% CI：0.61 - 0.87），PP分析为84.3%（95% CI：0.66 - 0.94）。HDDT组的研究完成率为97.2%（35/36）。双联疗法前3天高剂量雷贝拉唑诱导治疗以及在进餐和就寝时间服药的方案可实现可接受的根除率（>90%）和良好的药物依从性。
