基于Meta分析的冠心宁注射液辅助西医常规治疗不稳定型心绞痛临床评价研究

Meta-analysis of Guanxinning Injection Adjuvant Conventional Western Treatment in Treatment with Unstable Angina Pectoris

目的:系统评价冠心宁注射液辅助西医常规治疗不稳定型心绞痛的有效性、安全性。方法:计算机检索the Cochrane Library、PubMed、Embase、SinoMed、中国知网、维普期刊数据库和万方数据库有关冠心宁注射液治疗不稳定型心绞痛的随机对照试验文献,采用Cochrane风险评价表评价其研究质量,提取资料通过Rev Man 5.3进行Meta分析。结果:共纳入17个随机对照试验,累计1 517例患者。Meta分析结果显示,相较于单一西医常规疗法,冠心宁注射液辅助西医常规治疗不稳定型心绞痛能显著提高心绞痛疗效总有效率(RR=1.24,95%CI:1.18~1.30,P<0.000 01)、心电图疗效总有效率(RR=1.34,95%CI:1.24~1.46,P<0.000 01),此外,还能缓解心绞痛发作频率和中医证候、减少硝酸甘油用量和心肌耗氧量、减缓心率等。有8篇文献明确无不良反应,3篇文献报道了共28例不良反应,症状均较轻,且停药后症状消失,其他文献均未对安全性作出说明。结论:冠心宁注射液辅助西医常规治疗不稳定型心绞痛具有较好的疗效,安全性相对可靠。

Objective：To evaluate systematically the clinical effectiveness and safety of Guanxinning injection （GXN） adjuvant conventional western treatment in treatment with unstable angina pectoris （UAP）. Methods ：Randomized controlled trials regarding UAP treated by GXN and western medicines （WM） were searched in the China National Knowledge Infrastructure Database, China Scienceand Technology Journal Database, Wanfang Database, Chinese Biomedical Literature Database, the Cochrane Library, Embase and PubMed. Two reviewers independently retrieved RCTs and extracted information. The Cochrane risk of bias method was used to assess the quality of included studies, and a Meta-analysis was conducted with Review Manager 5.3 software. Results：IT studies involving 1 517 participants were included. Meta-analysis, the results of GXN group was significantly superior to the west conventional therapy group in angina pectoris curative effect （ RR = 1.24,95% CI： 1.18-1.30, P 〈 0. 000 01 ）, and the electrocardiogram curative effect （ RR = 1.34, 95% CI： 1.24-1.46, P 〈 0. 000 01 ）. Additionally, GXN also could relieve angina frequency and traditional Chinese medicine （TCM） symptoms, reduce the dosage of nitroglycerin and myocardial oxygen consumption, slow heart rate, and so on. 8 articles cleared that there were no ADRs in the studies, 3 studies reported ADRs. There were 14 cases in the experimental group, and 14 cases in control group. Conclusion：Comparing with WM, the combine use of GXN was more effective, its safety was relatively safe.