通心络胶囊用药安全性的系统评价  

Systemic review on safety of Tongxinluo Capsules

作　　者：张耀文[1] 方任飞[2] 杨超[2] 吴志军[2] 李桐桐[2] 吴宗贵[3] 董强[4] 

机构地区：[1]中日友好医院,北京100029 [2]北京大学公共卫生学院 [3]第二军医大学附属长征医院 [4]复旦大学附属华山医院

出　　处：《中国循证心血管医学杂志》2013年第4期337-342,348,共7页Chinese Journal of Evidence-Based Cardiovascular Medicine

基　　金：国家重点基础研究发展计划(973计划)项目(2012cb518606)

摘　　要：目的系统评价通心络胶囊用药安全性。方法计算机检索《中国生物医学文献数据库》、《中国期刊全文专题数据库》、《中国科技期刊数据库》、万方数据库、Cochrane图书馆和PubMed。手工检索中国药品不良反应监测中心发布的《药品不良反应信息通报》,检索时间为2003年1月至2013年5月。按纳入和排除标准筛选文献,评价文献质量,提取资料。临床试验文献采用MetaAnalyst 3.13进行Meta分析,其余文献采用描述性分析。结果纳入144篇临床试验研究,共有6254人使用通心络胶囊,6006人未使用。与其它化学药或中药相比,单独使用通心络胶囊的神经系统不良事件发生率低于单独使用化学药,同时,通心络胶囊组与对照组的各类型不良事件发生率均相当。在15个病例系列研究中,共701人使用通心络胶囊,其中发生胃肠道反应不良事件52例,皮炎或皮疹不良事件1例。2个病例报告报道1例皮炎或皮疹不良事件。结论通心络胶囊的总体安全性可接受,今后应加强药物不良反应/事件监测力度,为通心络胶囊的临床应用提供高质量证据。Objective To review systematically the safety of Tongxinluo Capsules. Methods The databases were retrieved with computer including Chinese BioMedical Database （CBM）, China National Knowledge Infrastructure （CNKI）, Chinese Science and Technique Journals Database （VIP）, Wanfang database, Cochrane Library and PubMed, and the“Adverse Drug Reaction Information Bulletin”released by Chinese Adverse Drug Reaction Monitoring Center was received manually from Jan. 2013 to May, 2013. Literature screening, quality assessment and data extraction were followed by inclusion and exclusion criteria. The clinical experimental literature was given a Meta-analysis by applying MetaAnalyst 3.13, and others were reviewed with descriptive analysis. Results There were 144 clinical studies included, and totally 6254 cases had Tongxinluo Capsules and 6006 had not. The incidence of adverse nervous system events was lower in the patients only taking Tongxinluo Capsules than those only taking chemical drugs compared with other chemical drugs or Chinese medicinal. For other types of adverse events, Tongxinluo Capsules was faired to chemical medicine or other Chinese medicinal. In 15 case-series studies, there were totally 701 patients taken Tongxinluo Capsules, of them 52 with gastrointestinal adverse events and 1 with dermatitis or rash adverse event. One case of dermatitis or rash adverse event was reported in two case reports. Conclusion The safety of Tongxinluo Capsules is acceptable, and the adverse drug reaction/event monitoring should be strengthened for providing high quality evidence for clinical application of Tongxinluo Capsules.

关 键 词：通心络胶囊 安全性 系统评价 

分 类 号：R282.7[医药卫生—中药学]