国产药物组成的四联疗法对胃炎及十二指肠溃疡患者幽门螺杆菌感染根除效果的前瞻性多中心随机对照研究  

Quadruple regimens using domestically manufactured drugs in gastritis and duodenal ulcer patients for Helicobacter pylori eradication： a perspective, multicenter, randomized controlled trial

作　　者：高文[1] 胡伏莲[1] 成虹[1] 王化虹[1] 杨云生[2] 梁浩[2] 张澍田[3] 孟凡冬[3] 崔梅花[4] 魏红[4] 盛剑秋[5] 安贺娟[5] 姜泊[6] 陈烨[6] 李延青[7] 左秀丽[7] 龚均[8] 赵萍[8] 董蕾[8] 王邦茂[9] 姜葵[9] 张桂英[10] 李建生[11] 赵晔[11] 郜恒骏[12] 杨丽[13] 

机构地区：[1]北京大学第一医院消化科,100034 [2]解放军总医院消化科 [3]首都医科大学附属北京友谊医院消化科 [4]航天中心医院消化科 [5]北京军区总医院消化科 [6]南方医科大学南方医院消化科 [7]山东大学齐鲁医院消化科 [8]西安交通大学第二附属医院消化科 [9]天津医科大学总医院消化科 [10]中南大学湘雅医院消化科 [11]河南医科大学第一附属医院消化科 [12]生物芯片上海国家工程研究中心 [13]同济大学附属同济医院消化科

出　　处：《中华医学杂志》2016年第4期260-264,共5页National Medical Journal of China

基　　金：中华医学会北京分会科研基金（2012007）

摘　　要：目的观察以国产雷贝拉唑为基础的四联疗法作为一线／初始方案对胃炎和十二指肠溃疡患者幽门螺杆菌（Hpylori）感染的根除效果及安全性，并探讨在常规四联疗法后延长铋剂使用时间对Hpylori根除率的影响。方法选取2013年1至8月全国12个中心接受胃镜检查并诊断伴有Hpylori感染的十二指肠溃疡或慢性胃炎患者共430例，进行Hpylori感染四联10d疗法初次根除治疗（雷贝拉唑＋阿莫西林＋克拉霉素＋枸橼酸铋钾，疗程10d）。采用前瞻性、随机双盲双模拟的平行对照多中心临床研究方法，将其中310例慢性胃炎患者采用分段随机法分为2组，A1组：四联疗法＋铋剂模拟（四联疗法后予铋剂模拟剂21d）；A2组：四联疗法＋铋剂延长（四联疗法后予枸橼酸铋钾21d）；各155例。120例十二指肠溃疡患者不分组，给予四联疗法后，继之雷贝拉唑14d。患者均在停药28d后进行13C尿素呼气试验检测Hpylori。结果最终共人组428例患者，其中404例完成试验。意向性分析（ITT）：慢性胃炎患者Hpylori总体根除率为85．1％（262／308），其中A1组根除率为81．7％（125／153），A2组根除率88．4％（137／155）；十二指肠患者Hpylori根除率为85．8％（103／120）。所有入组患者均无不良反应事件发生。A1和A2组药物对疼痛、烧灼感、反酸、嗳气、恶心呕吐等症状改善程度近似，均无严重不良反应发生。结论国产雷贝拉唑为基础的四联10d疗法作为一线／初始方案对初次治疗的慢性胃炎和十二指肠溃疡患者的Hpylori感染均能获得较好的根除效果；胃炎患者延长铋剂使用时间可能提高Hpylori根除成功率。含质子泵抑制剂及铋剂的四联方案具有较好的耐受性和临床安全性。Objective To observe the effects and safety of quadruple regimens including domestically manufactured rabeprazole used as first line/initial therapy for Helicobacter pylori （ H. pylori ） eradication in gastritis and duodenal ulcer patients, and to investigate the effects of extended use of bismuth after the quadruple therapy on eradication of H. pylori. Methods From January to August 2013, 430 patients with chronic gastritis or duodenal ulcer who were confirmed as H. pylori positive in gastroscopy for upper gastrointestinal symptoms were enrolled from 12 centers in China for initial treatment using quadruple regimens for H. pylori eradication. The study was a prospective, muhieenter, randomized double-blinded double-dummy parallel-controlled clinical trial. The 310 chronic gastritis patients were divided into 2 groups： group A1 was given quadruple regime （rabeprazole ＋ amoxicillin ＋ clarithromyein ＋ bismuth potassium citrate） for 10 days followed by bismuth-placebo for 21 days; group A2 was given the quadruple regimen for 10 days and then bismuth potassium citrate for 21 days. The duodenal ulcer patients were given the quadruple for 10 days, then rabeprazole for 14 days. All the patients took 13C urea breath test to detect tt. pylori 28 days after medicine withdrawal. Results Altogether 428 cases were enrolled and 404 completed the trial. The total eradication rate in the chronic gastritis patients was 85.1% （262/308, intention-to-treat （ITT） analysis）, which was 81.7% （125/153, ITT） in the A1 group and 88. 4% （137/155, ITT） in the A2 group; the eradication rate in the duodenal ulcer patients was 85.8% （103/120, ITT）. No severe adverse effects were reported. The symptoms （pain, burning sensation, reflux, belching, nausea, and vomiting） improvement status was similar among A1 and A2 groups. Conclusions The quadruple regimen using rabeprazole manufactured in China and administered for 10 days as first line/initial therapy in chronic gastritis and duodenal ulcer patients could

关 键 词：螺杆菌 幽门 铋 四联疗法 初始治疗 雷贝拉唑 

分 类 号：R573.1[医药卫生—消化系统]