10天伴同、序贯及含铋剂四联方案根除幽门螺杆菌效果的随机对照研究  

A randomized clinical trial of ten-day concomitant,sequential and bismuth-based quadruple therapies for Helicobacter pylori

作　　者：李月月[1] 左秀丽[1] 季锐[1] 陈飞雪[1] 赵宏宇[1] 王晗[1] 郭婧[1] 张菁媛 付姗姗[1] 刘建伟[1] 李延青[1] 

机构地区：[1]山东大学齐鲁医院消化内科,山东济南250012

出　　处：《山东大学学报（医学版）》2014年第7期45-49,共5页Journal of Shandong University:Health Sciences

摘　　要：目的通过比较10天伴同、序贯及含铋剂四联疗法三种方案对Hp的根除率,以确定最佳的四联治疗方案,进而指导临床实践。方法经快速尿素酶检查证实Hp的患者随机接受伴同方案(奥美拉唑20 mg、阿莫西林1 000 mg、克拉霉素500 mg、替硝唑500 mg)、序贯方案(前5天为奥美拉唑20 mg、阿莫西林1 000 mg,后5天为奥美拉唑20 mg、克拉霉素500 mg、替硝唑500 mg)或含铋剂方案(奥美拉唑20 mg、阿莫西林1 000 mg、克拉霉素500 mg、胶体果胶铋200 mg)治疗,每日2次用药,疗程均为10 d。患者停药后6周进行13C呼气试验检查,结果阴性者判为根除成功。结果意向性分析时,伴同方案、序贯方案和含铋剂方案对Hp的根除率分别为85.6%、70.7%、85.3%,伴同方案和含铋剂方案均显著优于序贯方案(P<0.05)。符合方案集分析显示,上述3组对Hp的根除率为87.8%、82.8%和88.9%,各方案之间的根除率均无统计学差异(P>0.05)。结论在临床工作中,10 d含铋剂四联方案可作为经验性治疗Hp感染的首选方案。Objective To determine the best empiric regimens to eradicate Helicobacter pylori（ Hp） in daily clinical work by comparing the efficacy of ten-day concomitant,sequential and bismuth-based quadruple therapies. Methods A total of 226 patients with H. pylori infection proved by rapid urease test（ RUT） were randomly divided into 3 groups,and received concomitant therapy（ omeprazole 20 mg,amoxicillin 1 000 mg,clarithromycin 500 mg and tinidazole 500mg）,sequential therapy（ omeprazole 20 mg,amoxicillin 1 000 mg for the first 5 days,followed by omeprazole 20 mg,clarithromycin 500 mg and tinidazole 500 mg for another 5 days）,and bismuth-based therapy（ omeprazole 20 mg,amoxicillin 1 000 mg,clarithromycin 500 mg and colloidal bismuth pectin 200 mg）,respectively. All regimens were taken twice a day for 10 days. Hp status was confirmed by13C-urea breath test 6 weeks after completion of treatment,and negative result was considered as successful in Hp eradication. Results In intention-to-treat analysis,the eradication rates of concomitant therapy,sequential therapy and bismuth-based therapy were 85. 6%,70. 7%,and 85. 3%,respectively. Either concomitant therapy or bismuth-based therapy was significantly superior to sequential therapy（ P 〈0. 05）. In per-protocol analysis,the eradication rates of the 3 regimens were 87. 8%,82. 8% and 88. 9%,respectively.And there was no statistic significance between any two of the three groups（ P〉 0. 05）. Conclusion Ten-day bismuth-based therapy can be adopted as the best empiric regimen to cure Hp infection in clinical work.

关 键 词：幽门螺杆菌 伴同方案 序贯方案 含铋剂方案 

分 类 号：R573[医药卫生—消化系统]