复方苦参结肠溶胶囊对比相关化学药治疗溃疡性结肠炎疗效和安全性的Meta分析  

Efficacy and Safety of Compound Kushen Colon-release Capsule versus Related Chemical Drugs in the Treatment of Colitis:A Meta-analysis

作　　者：李辉标[1] 陈慕媛[1] 陈新林[2] 丘振文[1] 李得堂[1] 唐洪梅[1] LI Huibiao;CHEN Muyuan;CHEN Xinlin;QIU Zhenwen;LI Detang;TANG Hongmei(Dept.of Pharmacy,the First Affiliated Hospital of Guangzhou University of TCM,Guangzhou 510405,China;College of Basic Medicine,Guangzhou University of TCM,Guangzhou 510006,China)

机构地区：[1]广州中医药大学第一附属医院药学部,广州510405 [2]广州中医药大学基础医学院,广州510006

出　　处：《中国药房》2018年第5期695-699,共5页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81403296);广州中医药大学第一附属医院"创新强院"工程青年科研人才培优项目(No.2017QN02)

摘　　要：目的:系统评价复方苦参结肠溶胶囊对比相关化学药治疗溃疡性结肠炎(UC)的疗效和安全性。方法:计算机检索Pub Med、Embase、Cochrane图书馆、中国期刊全文数据库、中文科技期刊数据库、中国生物医学文献数据库、万方数据库,收集复方苦参结肠溶胶囊对比相关化学药治疗UC疗效(有效率、中医证候疗效、黏膜病变疗效)和安全性(不良反应发生率)的随机对照试验(RCT),提取资料并采用Cochrane 5.1.0进行质量评价后,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入9项RCT,合计649例患者。Meta分析结果显示,复方苦参结肠溶胶囊治疗UC的有效率[OR=2.16,95%CI(1.28,3.63),P=0.004]、黏膜病变疗效[OR=2.42,95%CI(1.07,5.47),P=0.03]显著高于化学药,差异均有统计学意义;两组患者在中医证候疗效[OR=1.70,95%CI(0.87,3.32),P=0.12]、不良反应发生率[OR=1.15,95%CI(0.62,2.15),P=0.65]方面比较,差异均无统计学意义。结论:复方苦参结肠溶胶囊治疗UC的疗效较相关化学药好,安全性相当。OBJECTIVE:To systematically evaluate therapeutic efficacy and safety of Compound kushen colon-release capsule versus related chemical drugs in treatment of ulcerative colitis(UC).METHODS:Retrieved from PubMed,Embase,Cochrane library,China Journal Full-text Database(CJFD),VIP,CBM and Wanfang database,RCTs about therapeutic efficacy(response rate,TCM syndrome,therapeutic efficacy of mucosal lesion)and safety(the incidence of ADR)of Compound kushen entericrelease capsule versus related chemical drugs in the treatment of UC were collected.Meta-analysis was conducted by using Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane 5.1.0.RESULTS:A total of 9 RCTs were included,involving 649 patients.The results of Meta-analysis showed that response rate[OR=2.16,95%CI(1.28,3.63),P=0.004]and therapeutic efficacy of mucosal lesion[OR=2.42,95%CI(1.07,5.47),P=0.03]of Compound kushen colon-release capsule were significantly higher than that of chemical drugs in the treatment of UC,with statistical significance.There was no statistical significance in therapeutic efficacy of TCM syndrome[OR=1.70,95%CI(0.87,3.32),P=0.12]or the incidence of ADR between 2 groups.CONCLUSIONS:Therapeutic efficacy of Compound kushen colon-release capsule is better than that of related chemical drugs in the treatment of UC with similar safety.

关 键 词：复方苦参结肠溶胶囊 溃疡性结肠炎 META分析 疗效 安全性 

分 类 号：R574.62[医药卫生—消化系统]