摘要目的 通过一项前瞻性、单中心、开放性队列研究,探讨双联方案在幽门螺杆菌感染初治患者中的根除疗效、安全性和依从性.方法 2014年3月至2018年9月,北京大学第三医院收治的200例幽门螺杆菌感染初治的消化不良患者接受了14 d双联方案根除治疗(雷贝拉唑10 mg,阿莫西林500 mg,均4次/d口服).根除治疗结束后1～3 d返回评价安全性和依从性.根除治疗结束后4～8周返回进行13C-尿素呼气试验确定根除结果.部分患者进行了菌株培养、抗生素敏感性检测以及CYP2C19基因多态性测定.结果 双联方案根除率:意向性分析87.5％(175/200)(95％可信区间82.5％～91.5％)、调整的意向性分析90.2％(175/194)(86.1％～94.3％)以及遵循方案分析91.0％(172/189)(86.3％～94.7％).21.2％患者出现了不良反应,绝大多数为轻中度,仅有1.5％(3/200)因为无法耐受不良反应而停药.依从性好的患者占96.0％.因素分析结果显示依从性差和阿莫西林耐药是根除失败的独立危险因素.结论 雷贝拉唑和阿莫西林(4次/d,14 d)双联方案在幽门螺杆菌感染初治患者中取得了良好的根除疗效、安全性和依从性.

abstractsObjective To investigate the efficacy, safety and compliance of dual therapy for the first-line eradication of Helicobacter pylori infection through a prospective, single-center and open-label cohort study. Methods From March 2014 to September 2018, 200 na?ve patients with Helicobacter pylori infection and dyspepsia received 14-day dual therapy (rabeprazole 10mg and amoxicillin 500 mg, four times daily orally). Safety and compliance were assessed 1-3 days after eradication. The therapeutic outcome was determined by 13C-urea breath test 4-8 weeks after eradication. Some patients underwent strain culture, antibiotic sensitivity testing and CYP2C19 polymorphism assay. Results The eradication rates of dual therapy:intention-to-treat analysis 87.5％ (95％ confidence interval 82.5％-91.5％), modified intention-to-treat analysis 90.2％(86.1％-94.3％) and per-protocol analysis 91.0％(86.3％-94.7). 21.2％of patients had adverse reactions, the majority were mild to moderate, and only 1.5％ of patients discontinued medication because of intolerance to adverse reactions. Patients with good compliance accounted for 96.0％. Variate analyses showed that poor compliance and amoxicillin resistance were the independent risk factors for eradication failure. Conclusions 14-day dual therapy with rabeprazole and amoxicillin (four times daily) achieved good efficacy, safety and compliance for the first-line eradication of Helicobacter pylori infection.