冠心丹参滴丸治疗冠心病随机对照试验的系统评价  

Guanxin Danshen Drop Pill for Treatment of Coronary Heart Disease: A Systematic Review

作　　者：杨巧宁[1] 谷丰[1] 高铸烨[1] 张庆翔[1] 时莉晓[1] 李立志[1] 史大卓[1] 

机构地区：[1]中国中医科学院西苑医院心血管病研究所,北京100091

出　　处：《中国实验方剂学杂志》2014年第16期218-224,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-031);国家中医药行业科研专项(201007001);国家科技支撑计划项目(2011BAZ03237)

摘　　要：目的:系统评价冠心丹参滴丸治疗冠心病的有效性及安全性。方法:检索冠心丹参滴丸治疗冠心病的随机对照试验文献,无盲法和语言限制。筛选符合纳入标准的随机对照试验(RCTs),依据Jadad评分法进行文献的质量评价,采用Cochrane协作网提供的RevMan 5.2软件进行Meta分析。结果:共检索到15篇文献,1 455名患者符合纳入标准。所有试验Jadad评分均<3分,无双盲试验。发表偏倚分析显示倒漏斗图不对称。冠心丹参滴丸组在改善心绞痛症状总有效率方面优于对照组[RR=1.17,95%CI(1.11,1.22)],心电图疗效总有效率优于对照组[RR=2.36,95%CI(1.84,3.02)]。血液流变学指标中,冠心丹参滴丸组在改善全血黏度、血浆黏度、红细胞压积、纤维蛋白原方面优于对照组,合并加权均数差(WMD)分别为[-0.86,95%CI(-1.43,-0.28)],[-0.35,95%CI(-0.56,-0.15)],[-3.3,95%CI(-4.07,-2.53)],[-0.76,95%CI(-1.05,-0.48)]。试验过程中未发现明显不良反应。结论:在常规治疗基础上加用冠心丹参滴丸,较单纯常规治疗可进一步改善冠心病的临床症状、心电图及血液流变学指标。但由于存在发表性偏倚及文献质量偏低,仍需高质量临床试验加以证实。Objective：This study aimed to systematically review the efficacy and safety of Guanxin Danshen drop pill for coronary heart disease （CHD）.Method：We search the literatures on randomized controlled trials （RCTs） using Guanxin Danshen drop pill for the treatment of coronary heart disease from public database such as Pubmed,Cochrane library,China Biology Medicine disc （CBM）,CNKI,and Wanfang Data.RevMan5.2 was used in the analysis.Result：Fifty RCTs including 1 455 patients met the inclusion criteria.All the trials were not adequate in methodological quality.None of them was double-blinded trial.There was a significant funnel plot asymmetry,which means publication bias has been found.Compared with the control group,the treatment group showed significantly higher total effective rate [RR =1.17,95％ CI （1.11,1.22）] at improving angina symptoms,and the total effectiveness rate [RR =2.36,95％ CI （1.84,3.02）] at ameliorating the electrocardiogram effect,as well.As for the indexes of blood rheology,blood viscosity,plasma viscosity,hematocrit and fibrinogen in treatment group were superior to the contrast group （P ＜ 0.01）,weighted mean difference were [-0.86,95％CI （-1.43,-0.28）],[-0.35,95％CI （-0.56,-0.15）],[-3.3,95％ CI （-4.07,-2.53）],[-0.76,95％ CI （-1.05,-0.48）].There were no obvious side-effects found in the trials.Conclusion：The present Meta-analysis suggested that on the basis of conventional western medicine,Guanxin Danshen drop pill is helpful to improve symptoms,alleviate the ischemia of electrocardiogram and improve blood rheology indexes,however,high-quality evidences of evidence-based medicine （EBM） are needed due to publication bias and low quality of RCT.

关 键 词：冠心丹参滴丸 冠心病 随机对照试验 META分析 

分 类 号：R287[医药卫生—中药学]