优化的伴同方案在幽门螺杆菌感染初治患者中的根除治疗研究

目的通过一项前瞻性、单中心、开放性队列研究,探讨优化的伴同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1月至2018年10月,200例幽门螺杆菌感染初治的消化不良患者接受了14d伴同方案根除治疗(艾司奥美拉唑40mg,阿莫西林1000mg,克拉霉素500mg,替硝唑500mg均每天2次口服)。根除治疗结束后1~3d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。结果优化的伴同方案根除率:意向性分析88.0%(95%可信区间83.0%~92.0%)、调整的意向性分析91.2%(87.0%~94.8%)以及遵循方案分析93.0%(89.2%~96.2%)。43.1%患者出现了不良反应绝大多数为轻中度,仅有3.0%因为无法耐受不良反应而停药。依从性好患者占94.4%。因素分析结果显示依从性差和克拉霉素耐药是根除失败的独立危险因素。结论优化的伴同双联方案(14 d疗程,双倍剂量艾司奥美拉唑)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。

Optimized Concomitant Therapy for the First-line Eradication of Helicobacter pylori Infection

OBJECTIVE To investigate the efficacy,safety and compliance of optimized concomitant therapy for the first-line eradication of Helicobacter pylori infection through a prospective,single-center and open-label cohort study.METHODS From January2014 to October 2018,200 nafive patients with Helicobacter pylori infection and dyspepsia received 14 d concomitant therapy(esomeprazole 40 mg,amoxicillin 1000 mg,clarithromycin 500 mg and tinidazole 500 mg,twice 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 CYP2 C19 polymorphism assay.RESULTS The eradication rates of optimized concomitant therapy:intention-to-treat analysis 88.0%(95% confidence interval 83.0%-92.0%),modified intention-to-treat analysis 91.2%(87.0%-94.8%)and per-protocol analysis 93.0%(89.2%-96.2%).43.1%of patients had adverse reactions,the majority were mild to moderate,and only 3.0%of patients discontinued medication because of intolerance to adverse reactions.Patients with good compliance accounted for 94.4%.Variate analyses showed that poor compliance and clarithromycin resistance were the independent risk factors for eradication failure.CONCLUSION Optimized concomitant therapy(14d duration and double dose of esomeprazole)achieved good efficacy,safety and compliance for the first-line eradication of Helicobacter pylori infection.