苦碟子注射液(碟脉灵)疗效评价文献的分析  

Literature review report on efficacy evaluation about Kudiezi injection

作　　者：廖星[1] 申浩[1] 谢雁鸣[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2012年第18期2810-2813,共4页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030)"中药上市后评价关键技术研究";中国中医科学院第6批自主选题项目(Z0215)

摘　　要：目的:对有关苦碟子注射液发表的相关疗效评价文献进行分析,获得其临床用药信息。方法:通过检索相关数据库,筛选后,最终获得有关苦碟子(主要为碟脉灵)临床疗效评价相关的文献237篇,分为4大类设计类型:3篇系统综述;190篇随机对照试验;20篇非随机对照试验;21篇病例系列报告;3个单病例报告。该文对3篇系统综述,190篇随机对照试验做了相关分析。结果:通过分析发现:苦碟子注射液在临床应用中,以脑血管疾病较多,如脑梗死,其次为心血管疾病,如心绞痛、冠心病等。文献还报道了说明书以外的多种疾病治疗使用苦碟子注射液。结论:从文献角度来看,苦碟子注射液的临床研究随着研究方法的不断进步,其研究的数量和质量均有提升。经典的随机对照试验设计研究可以为下一步的深入研究提供不同方面的参考信息。Objective： To explore information about label use and off label use about Kudeizi injection in clinical practice. Method： Three Chinese literature databases were searched and 237 articles were downloaded. Efficacy evaluation information about the study question was extracted by researchers in the Excel form. Finally, 3 systematic reviews and 190 RCTs, 20 clinical controlled trials, 21 case series and 3 case reports were identified. It only did an overview on three systematic reviews and 190 RCTs. Result： It is found that the most common disease treated by Kudiezi injection were cerebral infarction, coronary heart disease and angina pectoris. There are also many off label use about Kudiezi injection. Conclusion： Although there are more or less quality problems for these clinical trials of Kudiezi injection, researchers have already made effort to improve trials. There will be still a long way to develop good clinical trials for Kudiezi injection.

关 键 词：苦碟子注射液(碟脉灵) 疗效评价 文献分析 

分 类 号：R259[医药卫生—中西医结合]