冠心丹参滴丸治疗冠心病心绞痛疗效与安全性系统评价

目的:系统评价冠心丹参滴丸治疗冠心病心绞痛的疗效与安全性。方法:计算机检索自建库至2019年10月CNKI-WanFang-VIP-SinoMed-PubMed-Web of Science-Cochrane Library数据库,搜索并筛选符合纳入标准的冠心丹参滴丸治疗冠心病心绞痛的随机对照试验。按Cochrane手册5.1.0推荐的质量评价标准对纳入研究的RCT文献进行偏倚分析,采用RevMan 5.3软件进行Meta分析。结果:共纳入24篇文献,Meta分析结果显示:冠心丹参滴丸与西药联合应用较单纯西药治疗在心绞痛症状改善方面疗效较好(RR=1.20,95%CI:(1.10,1.30),Z=4.18,P<0.0001)]; 冠心丹参滴丸可有效改善患者心电图疗效(RR=1.27,95%CI:1.19,1.34],Z=7.60,P<0.00001),降低心绞痛发作频率(WMD=-0.93,95%CI:-1.18,-0.69],Z=7.53,P<0.00001)。结论:冠心丹参滴丸治疗冠心病心绞痛有一定的疗效,其在血脂水平及血液流变学指标等方面也具有统计学意义,治疗效果明显优于单纯常规治疗或西医治疗。不良反应情况较为轻微,提示安全性较好,但受到纳入研究的质量影响,部分结局指标可能存在偏倚,因此,近一步证据仍有待高质量大样本随机对照试验提供。

Effectiveness and safety of Guanxin Danshen dropping pills in the treatment of angina pectoris of coronary atherosclerotic heart disease:a systematic review of randomized controlled trials

Objective:To valuate the efficacy and safety of Guanxin Danshen dropping pills in the treatment of angina pectoris of coronary heart disease.Methods:The computer searched the CNKI、WanFang、VIP、SinoMed、PubMed、Web of Science、Cochrane Library database from the establishment of the database to October 2019,and searched and screened the randomized controlled trial of Guanxin Danshen dropping pills in the treatment of angina pectoris of coronary atherosclerotic heart disease.According to the quality evaluation standard recommended by Cochrane Manual 5.1.0,the RCT literature included in the study was biased and Meta was analyzed by RevMan 5.3 software.Results:A total of 24 articles were included.Meta-analysis showed that Guanxin Danshen dropping pills combined with western medicine was more effective in improving angina pectoris symptoms than western medicine alone(RR=1.20,95%CI:1.10,1.30],Z=4.18,P<0.0001).Guanxin Danshen dropping pills can effectively improve the curative effect of electrocardiogram(RR=1.27,95%CI:1.19,1.34],Z=7.60,P<0.00001),reduce the frequency of angina pectoris(WMD=-0.93,95%CI:-1.18,-0.69],Z=7.53,P<0.00001).Conclusion:Guanxin Danshen dropping pills has certain curative effect on angina pectoris of coronary atherosclerotic heart disease and also have statistical significance in blood lipid level and hemorheological indexes,and the therapeutic effect is obviously better than that of routine treatment or western medicine alone.The adverse reactions were mild,suggesting that the safety was better.However,due to the influence of the quality of the study,some outcome indicators may be biased,so the further evidence still needs to be provided by high quality large sample randomized controlled trials.