左氧氟沙星三联7d方案和标准三联10d方案初次根除幽门螺杆菌的疗效观察

摘要

目的 观察左氧氟沙星三联7 d方案和标准三联10 d方案用于幽门螺杆菌(Hp)初次治疗方案的有效性和安全性.方法 共收集240例Hp阳性的慢性胃炎或消化性溃疡患者,随机分为左氧氟沙星组(EAL组,n=120)和标准三联组(EAC组,n=120).EAL组口服埃索美拉唑20 mg+阿莫西林1 000 mg,2次/d,左氧氟沙星500 mg 1次/d,疗程7 d;EAC组口服埃索美拉唑20 mg+克拉霉素500 mg+阿莫西林1 000 mg,2次/d,疗程10 d.治疗结束4周后,采用14C尿素呼气实验判断根除结果.结果 共有219例完成随访,按意向治疗(ITT)分析Hp根除率显示,EAL组为80.0%,EAC组为75.8%,两组间比较差异无统计学意义.按符合方案(PP)分析Hp根除率,EAL组为88.9%,EAC组为82.0%,两组间比较差异无统计学意义.对影响Hp根除疗效的因素进行单因素Logistic回归分析显示,疾病类型中消化性溃疡患者Hp根除率高于慢性胃炎患者,两组间比较差异有统计学意义(P=0.032);多因素Logistic回归分析显示,疾病类型是Hp根除疗效的影响因素(OR=0.370,P=0.032).两组费用-效果比分别为302.40元和860.31元,EAL组远低于EAC组.结论 左氧氟沙星三联7 d疗法根除率较高、费用低、疗程短、患者耐受性好、不良反应少,可以被推荐为根除幽门螺杆菌的初次治疗方案.%Objective To observe the therapeutic effect and safety of levofloxacin-based triple regimen and standard triple regimen as the first-line therapy for Helicobacter pylorii. Hp ) infection. Methods 240 patients with Hp infection suffering from chronic gastritis or peptic ulcer were randomly assigned to group EAL( n = 120 )and group EAC( n = 120 ). Patients in group EAL received therapy with esomeprazole 20 mg plus amoxicillin 1 000 mg twice a day and levofloxacin 500 mg once a day for 7 days. Patients in group EAC received esomeprazole 20 mg, amoxicillin 1 000 mg and clarithromycin 500 mg, all twice a day for 10 days. Hp status was rechecked by 14C -urea breath test 4 weeks after the end of therapy. Results 219 patients completed the follow-up. The eradication rate in intention to treat( ITT ) and per protocol PP ) analysis were: group EAL 80. 0% ,88. 5% and group EAC 75. 8% , 82. 0% . No significant difference was found between the two triple therapies( P = 0. 439 and 0. 149 respectively ). Single-factor logistic analyse suggested that the eradication rate of peptic ulcer patients was higher than that of chronic gastritis patients, the significant difference was found between the two types of diseases( P = 0. 032 ); Multifacto-rial logistic analyse suggested that the type of disease was the factor affecting the rate of eradication( OR =0. 370, P = 0. 032 ). The ratio of cost-effectiveness of group EAL was much lower than that of group EAC ( 302. 40 yuan RMB vs 860. 31 yuan RMB ). Conclusion A 7-day levofloxacin-based triple therapy can achieve good radication rate and it has short duration,few side effect and good tolerance. It is worthy to be extended as one effective therapy for the first-line anti-H treatment.