目的:系统评价丹红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Cochrane Library,Pub Med、CBM、中国知网、维普期刊数据库和万方数据库有关丹红注射液辅助西医常规治疗不稳定型心绞痛的随机对照临床试验文献,采用Cochrane风险评价表评价其研究质量,提取资料通过Rev Man 5.2进行Meta分析,采用Egger’s检验和非参数剪补法评估发表偏倚。结果:共纳入19个随机对照试验,累计2 012名患者。Meta分析结果显示,丹红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,能显著提高心绞痛疗效总有效率(RR=1.26,95%CI:1.20~1.31,P<0.000 01)、心电图疗效总有效率(RR=1.28,95%CI:1.21~1.36,P<0.000 01),降低总胆固醇水平(MD=-1.16,95%CI:-1.37~-0.95,P<0.000 01)、三酰甘油水平(MD=-0.72,95%CI:-0.75~-0.68,P<0.000 01)、低密度脂蛋白胆固醇水平(MD=-0.78,95%CI:-0.98~-0.58,P<0.000 01)、升高高密度脂蛋白胆固醇水平(MD=0.29,95%CI:0.18~0.40,P<0.000 01),此外,还能缓解心绞痛发作频率、减少心绞痛持续时间、降低高敏C反应蛋白等。有12篇文献明确无不良反应,2篇研究报道了共15例不良反应,其他文献均未对安全性进行说明。结论:丹红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,其安全性尚不能得到确切的结论。 Objective: To systematically evaluate the effectiveness and safety of Danhong injection in assisting conventional western medicine in the treatment of unstable angina pectoris. Methods: Cochrane Library, PubMed, CBM, CNKI, VIP database and Wanfang database were searched for randomized controlled clinical trials of Danhong injection to assist conventional western medicine in the treatment of unstable angina pectoris. The Cochrane Risk Assessment Scale Quality of study, data extraction Meta-analysis was performed using Rev Man 5.2 and publication bias was evaluated using Egger’s test and nonparametric shearing. RESULTS: A total of 19 randomized controlled trials were included, with a total of 2,012 patients. Meta-analysis showed that Danhong injection could ameliorate conventional angina pectoris unstable angina pectoris and improve the total effective rate of angina pectoris (RR = 1.26, 95% CI: 1.20 ~ 1.31, P <0.000 01) The total effective rate of ECG (RR = 1.28, 95% CI: 1.21-1.36, P <0.000 01) decreased the total cholesterol level (MD = -1.16,95% CI -1.37-0.95, P 0.0001) The level of triglyceride (MD = -0.72, 95% CI: -0.75 ~ -0.68, P <0.000 01), LDL cholesterol (MD = -0.78, 95% CI -0.98 ~ -0.58, P < 0.000 01) increased HDL-C levels (MD = 0.29, 95% CI: 0.18-0.40, P <0.000 01). In addition, it also relieved the frequency of angina attacks, reduced the duration of angina pectoris, and decreased the levels of high-sensitivity C-reactive protein Wait. Twelve articles clearly had no adverse reactions, and two studies reported a total of 15 adverse reactions. No other literature described safety. CONCLUSION: Danhong injection has the good curative effect to assist the routine treatment of unstable angina in Western medicine, and its safety can not get the exact conclusion.