益气活血法配伍治疗不稳定性心绞痛临床疗效的Meta分析

The Method of Invigorating Qi and Activating Blood Circulation in the Treatment of Unstable Angina:A Meta-analysis

目的系统评价益气活血法配伍治疗不稳定性心绞痛(UA)的临床总疗效、心绞痛疗效、心电图疗效和中医证候疗效,并评估其安全性。方法检索中国生物医学文献数据库(CBM)、中国知识基础设施工程(CNKI)、维普中文期刊服务平台数据库(VIP)、万方数据知识服务平台(WanFang Data)等数据库,搜集益气活血法配伍治疗UA的随机对照试验(RCT),检索时限为自数据库建立至2019年3月30日,对检索文献进行筛选和资料提取,采用改良后Jadad量表对文献质量进行评估,并用RevMan5.3软件对数据进行分析。结果最终纳入49篇文献,共3963例病例。Meta分析结果显示,益气活血法配伍的治疗组在临床总疗效[OR=4.22,95%CI(3.14,5.69),P<0.00001]、心绞痛疗效[OR=1.22,95%CI(1.17,1.28),P<0.00001]、心电图疗效[OR=2.87,95%CI(2.43,3.39),P<0.00001]、中医证候疗效[OR=4.35,95%CI(3.18,5.95),P<0.00001]等方面优于单纯以西药抗缺血、抗血小板聚集与抗凝等为主治疗的对照组,差异具有统计学意义。安全性方面,文献报道中尚未有血、尿常规及肝肾功能损伤的病例,但对药物的长期安全性评价较少。结论当前证据表明,益气活血法配伍治疗UA具有可靠的临床总疗效、心绞痛疗效、心电图疗效和中医证候疗效,安全性较好,但缺乏对药物长期的安全性评价,对临床扩大使用中医药益气活血法治疗UA具有一定的指导意义。

Objective To systematically evaluate the total clinical effect,the therapeutic effects on angina pectoris,eletrocardiogram(ECG)and TCM syndrome about the method of invigorating qi and activating blood circulation in curing unstable angina(UA),and to evaluate the safety of the method.Methods Chinese Biological Medical Database(CBM),China National Knowledge Infrastructure(CNKI),VIP and WanFang Data were searched and to get the randomized controlled trial(RCT)of invigorating qi and activating blood circulation in curing UA.It covered all the trial from the database was setup to March 30,2019.Then screened out and extracted data from the retrieved trials.The modified Jadad was used to evaluate quality of the selected trials.ReMan5.3 was used for Meta-analyze the data.Results A total of 49 trials were finally included,which contain 3963 clinical cases.Meta analysis results showed that the method of invigorating qi and activating blood circulation in curing UA has significant total clinical effect[OR=4.22,95%CI(3.14,5.69),P<0.00001],and the therapeutic effects on angina pectoris[OR=1.22,95%CI(1.17,1.28),P<0.00001],ECG[OR=2.87,95%CI(2.43,3.39),P<0.00001]and TCM syndrome[OR=4.35,95%CI(3.18,5.95),P<0.00001].The results were superior to the control group which was treated by western medicine with antiischemic therapy,antiplatelet therapy and anticoagulant therapy.The difference was statistically significant,there were no case reported the impairment of blood routine,urine routine,and liver and renal functions.But there was less reporting about long-term safety evaluation of drugs.Conclusions Current evidences shows that the method of invigorating qi and activating blood circulation in curing UA has reliable total clinical effect,the therapeutic effects on angina pectoris,eletrocardiogram(ECG)and TCM syndrome.The method has good safety,which lacks of long-term safety evaluation nevertheless.There are some value in guiding in clinical about the usage of the method.