标题：含铋剂四联疗法作为一线方案根除幽门螺杆菌的临床研究

      作者：章金艳，刘 明，栗 华，郑建玮，林冠霞，陈雅真
    (厦门大学附属第一医院消化内科，福建 厦门 361003)

      卷次： 2012年23卷12期

      【摘要】 目的 评价含铋剂的四联 10 d疗法作为一线方案治疗幽门螺杆菌感染的有效性和安全性。
方法 将140例幽门螺杆菌感染的初治患者随机分为三联治疗组和四联治疗组各70例。三联治疗组给予埃索
美拉唑 20 mg bid+克拉霉素 500 mg bid+阿莫西林 1.0 g bid治疗7 d，四联治疗组给予埃索美拉唑 20 mg bid+克
拉霉素 500 mg bid+阿莫西林 1.0 g，bid+果胶铋 150 mg tid治疗10 d。疗程结束6周后复查13C-尿素呼气试验，
判断幽门螺杆菌根除情况，同时观察治疗过程中的不良反应。结果 三联治疗组按方案(PP)分析和按意向治疗
(ITT)分析H. pylori的根除率分别为76.5%、74.3%，四联治疗组按PP和按 ITT分析根除率分别为92.5%、88.6%，四
联治疗组按PP和 ITT分析H. pylori的根除率均高于三联治疗组(P值分别为0.010、0.030)。两组不良反应发生率
相似，无严重的不良反应病例。结论 含铋剂的四联10 d疗法用于幽门螺杆菌感染的初治，疗效高于标准三联
7 d疗法，是一种可供选择的一线治疗方案。

      【关键词】 幽门螺杆菌；四联疗法；标准三联疗法

      【中图分类号】 R378.2 【文献标识码】 A 【文章编号】 1003—6350(2012)12—012—03<

br>Clinical study of bismuth-based quadruple therapy as first-line therapy for the eradication of Helicobacter
pylori.
ZHANG Jin-yan, LIU Ming, LI Hua, ZHENG Jian-wei, LIN Guan-xia, CHEN Ya-zhen. Department of
Gastroenterology, the First Affiliated Hospital of Xiamen University, Xiamen 361003, Fujian, CHINA

【Abstract】 Objective To evaluate the efficacy and safety of the 10-day bismuth-based quadruple therapy as
first-line therapy for the eradication of Helicobacter pylori. Methods A total of 140 patients with H. pylori infection
were enrolled and randomly assigned into triple therapy groups and quadruple therapy groups, each with 70 cases. Pa-
tients in the triple therapy group received esomeprazole 20 mg BID, clarithromycin 500 mg BID and amoxicillin 1.0 g
BID for seven days. Patients in the quadruple therapy group received esomeprazole 20 mg BID, clarithromycin 500
mg BID, amoxicillin 1.0 g BID and pectin bismuth 150 mg TID for ten days. H. pylori eradication was assessed by
13C-urea breath test six weeks after cessation of therapy, and the safety was also evaluated. Results The per-proto-
col (PP) and intention-to-treat (ITT) eradication rates were 76.4% and 74.3% in the triple therapy group, and 92.5%
and 88.6% in the quadruple therapy group, respectively. The eradication rate was significantly higher in the quadruple
therapy group compared with the triple therapy group in both the PP and ITT populations (P=0.010 and P=0.030, re-
spectively), whereas the incidence of adverse events was similar. No serious adverse reactions occurred in the two
groups. Conclusion In the initial treatment of H. pylori infection, the 10-day bismuth-based quadruple therapy as
first-line therapy can achieve a higher eradication rate than the 7-day standard triple therapy.

      【Key words】 Helicobacter pylori; Quadruple therapy; Standard triple therapy