丹红注射液联合西药常规治疗不稳定型心绞痛疗效和安全性系统评价

Efficacy and Safety of Danhong Injection Plus Conventional Western Medicine for Unstable Angina:A Systematic Review

目的系统评价丹红注射液联合西药常规治疗不稳定型心绞痛的有效性与安全性。方法检索PubMed、Medline、中国期刊全文数据库、万方数据知识服务平台中丹红注射液联合西药常规治疗不稳定型心绞痛的临床随机对照试验文献,按照Cochrane协作网推荐的方法评价纳入研究文献的质量后,采用Rev-Man 4.2软件进行Meta分析。结果经筛选纳入23篇文献,共2 675例,其中治疗组(丹红注射液联合西药常规治疗)1 382例,对照组(单纯西药治疗)1 293例。各研究基线情况具有可比性。Meta分析结果显示:丹红注射液加西药常规治疗在提高心电图疗效[RR=2.84,95%CI(2.28,3.55)]、心绞痛疗效[RR=4.13,95%CI(3.12,5.47)],升高高密度脂蛋白-胆固醇[high density lipoprotein-cholesterol,HDL-C)(WMD=0.29,95%CI(0.05,0.52)],降低低密度脂蛋白-胆固醇(low density lipoprotein-cholesterol,LDL-C)[WMD=-0.98,95%CI(-1.33,-0.63)]和高敏C反应蛋白(high sensitive C-reactive protein,hs-CRP)[WMD=-1.42,95%CI(-2.18,-0.65)]方面均优于西药常规治疗组。结论丹红注射液联合西药常规治疗在改善不稳定型心绞痛患者的心电图疗效,升高HDL-C,降低LDL-C和hs-CRP水平方面优于对照组。受纳入文献质量的限制,本研究结论尚需更多高质量大样本的临床随机双盲对照研究加以验证。

Objective To systematically evaluate the efficacy and safety of Danhong Injection,a patent traditional Chinese Medicine（TCM） mainly composed of Salvia miltiorrhiza and safflower for activating blood stasis,combined with conventional western medicine in the treatment of unstable angina.Methods The literatures,which involve with randomized controlled trials（RCTs） of Danhong Injection combined with conventional western medicine in the treatment of unstable angina,were retrieved in the databases such as PubMed,Medline,Chinese Journal Full-text Database,and Wanfang Data Knowledge Service Platform.The quality of literatures was evaluated according to the methods of the Cochrane Collaboration,and meta analysis was performed with RevMan 4.2 software.Results Twenty-three trials involving 2 675 patients were included,with 1 382 cases in the treatment group（Danhong Injection plus western medicine）,and 1 293 cases in the controlled group（conventional western medicine）.The baseline data of each study were comparable.The results of meta-analysis showed that the combination of Danhong Injection and western medicine was superior to the control treatments with a significant difference in ameliorating electrocardiogram（ECG） abnormality [relative risk（RR）=2.84,95% confidence internal（CI）（2.28,3.55）],alleviating angina [RR=4.13,95% CI（3.12,5.47）],increasing the serum levels of high density lipoprotein-cholesterol（HDL-C）[weight mean difference（WMD）=0.29,95% CI（0.05,0.52）],and decreasing low density lipoprotein-cholesterol（LDL-C）[WMD=-0.98,95% CI（-1.33,-0.63）] and high sensitive C-reactive protein（hs-CRP）[WMD=-1.42,95% CI（-2.18,-0.65） ].Conclusion Compared with conventional western medicine,the combination of Danhong Injection and western medicine can significantly ameliorate ECG abnormality,alleviate angina,increase the serum levels of HDL-C,and decrease the serum levels of LDL-C and hs-CRP.Meanwhile,more double blind RCTs with high quality and large-scale are required to verify this conclusion because of lack of high quality studies with large sample size.