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14 d伴同方案根除治疗(艾司奥美拉唑40 mg,阿莫西林1 000 mg,克拉霉素500 mg,替硝唑500 mg,均每天2次口服)。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 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。
Abstract
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 January 2014 to October 2018, 200 nafive patients with Helicobacter pylori infection and dyspepsia received 14 d concomitant therapy (esomeprazole 40 mg, amoxicillin 1 000 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 CYP2C19 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 (14 d duration and double dose of esomeprazole) achieved good efficacy, safety and compliance for the first-line eradication of Helicobacter pylori infection.
关键词
幽门螺杆菌 /
伴同方案 /
根除率 /
安全性 /
依从性
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Key words
Helicobacter pylori /
concomitant therapy /
eradication rate /
safety /
compliance
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中图分类号：
R573
R975
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参考文献
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脚注
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基金
国家自然科学基金面上项目资助(81670605);北京市幽门螺杆菌感染和上消化道疾病重点实验室项目资助(BZ0371);北京大学第三医院临床重点项目资助(Y76493-05)
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