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

doi:10.6040/j.issn.1671-7554.0.2013.750

山东大学学报（医学版） ›› 2014, Vol. 52 ›› Issue (7): 45-49.doi: 10.6040/j.issn.1671-7554.0.2013.750

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

李月月, 左秀丽, 季锐, 陈飞雪, 赵宏宇, 王晗, 郭婧, 张菁媛, 付姗姗, 刘建伟, 李延青

山东大学齐鲁医院消化内科, 山东济南 250012

收稿日期:2013-12-13 修回日期:2014-06-12 出版日期:2014-07-10 发布日期:2014-07-10
通讯作者: 李延青。E-mail：liyanqing@sdu.edu.cn E-mail:liyanqing@sdu.edu.cn

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

LI Yueyue, ZUO Xiuli, JI Rui, CHEN Feixue, ZHAO Hongyu, WANG Han, GUO Jing, ZHANG Jingyuan, FU Shanshan, LIU Jianwei, LI Yanqing

Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan 250012, Shandong, China

Received:2013-12-13 Revised:2014-06-12 Online:2014-07-10 Published:2014-07-10

摘要/Abstract

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。

关键词: 幽门螺杆菌, 伴同方案, 含铋剂方案, 序贯方案

Abstract: 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 500 mg), 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 by ¹³C-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.

Key words: Helicobacter pylori, Concomitant therapy, Sequential therapy, Bismuth-based therapy

中图分类号:

R573

李月月, 左秀丽, 季锐, 陈飞雪, 赵宏宇, 王晗, 郭婧, 张菁媛, 付姗姗, 刘建伟, 李延青. 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[J]. 山东大学学报（医学版）, 2014, 52(7): 45-49.

LI Yueyue, ZUO Xiuli, JI Rui, CHEN Feixue, ZHAO Hongyu, WANG Han, GUO Jing, ZHANG Jingyuan, FU Shanshan, LIU Jianwei, LI Yanqing. A randomized clinical trial of ten-day concomitant, sequential and bismuth-based quadruple therapies for Helicobacter pylori[J]. JOURNAL OF SHANDONG UNIVERSITY (HEALTH SCIENCES), 2014, 52(7): 45-49.

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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

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