目的 系统评价心可舒联合常规西药治疗不稳定型心绞痛的有效性及安全性。方法 检索PubMed数据库、维普数据库、中国知网、万方数据库等数据库自建库以来至2020年4月收录的关于心可舒联合常规西药治疗不稳定型心绞痛的临床随机对照试验，根据纳入及排除标准筛选文献，使用Rev Man5.3软件进行Meta分析。结果 共纳入19项随机对照试验，合计1 569例患者，Meta分析结果显示，：心可舒联合常规西药在减少心绞痛发作频率（SMD=-1.16，95% CI[-1.75，-0.57]，P=0.000 1），降低心绞痛持续时间（MD=-2.75，95% CI[-3.77，-1.73]，P<0.000 01），减少硝酸甘油用量（MD=-0.67，95% CI[-0.78，-0.56]，P<0.000 01），改善心电图疗效（RR=1.26，95% CI[1.18，1.35]，P<0.000 01）、心绞痛疗效（RR=1.26，95% CI[1.20，1.33]，P<0.000 01），降低三酰甘油（MD=-0.57，95% CI[-1.02，-0.12]，P=0.01）、总胆固醇（MD=-0.78，95% CI[-1.15，-0.41]，P<0.000 1）、低密度脂蛋白胆固醇（MD=-0.58，95% CI[-0.80，-0.36]，P<0.000 01），提高高密度脂蛋白胆固醇（MD=0.24，95% CI[0.08，0.40]，P=0.004）、降低全血黏度（MD=-1.32，95% CI[-2.25，-0.39]，P=0.005）、血浆黏度（MD=-0.29，95% CI[-0.38，-0.21]，P<0.000 01）、纤维蛋白原（MD=-1.06，95% CI[-1.29，-0.83]，P<0.000 01）、降低C-反应蛋白（MD=-1.70，95% CI[-2.33，-1.06]，P<0.000 01）、内皮素-1（MD=-7.81，95% CI[-10.05，-5.57]，P<0.000 01）、同型半胱氨酸（MD=-2.35，95% CI[-2.63，-2.07]，P<0.000 01），改善一氧化氮（MD=8.74，95% CI[7.00，10.47]，P<0.000 01）方面的作用优于单纯西药组，且亚组分析结果显示治疗疗程大于等于3个月的治疗效果更好，不良反应发生率方面差异无统计学意义（P=0.56），各研究均未出现肝肾功异常。结论 临床应用心可舒联合常规西药治疗不稳定型心绞痛的疗效明确，推荐临床应用。

Objective To systematically evaluate the efficacy and safety of Xinkeshu combined with conventional western medicine in the treatment of unstable angina pectoris. Methods The randomized controlled clinical trials of Xinkeshu combined with conventional western medicine for the treatment of unstable angina pectoris were searched from PubMed database, Viper database, CNKCN, Wanfang database and other databases from the establishment of the database to April 2020.The literatures were screened according to inclusion and exclusion criteria, and Rev Man5.3 software was used for Meta analysis. Results A total of 1569 patients were included in 19 randomized controlled trials. Meta-analysis results showed that Xinkeshu combined with conventional western medicine reduced the frequency of angina attacks (SMD=-1.16, 95%CI[-1.75, -0.57], P=0.000 1), decreased the duration of angina (MD=-2.75, 95%CI[-3.77, -1.73], P<0.000 01), reduced the dosage of nitroglycerin (MD=-0.67, 95%CI[-0.78,-0.56], P<0.000 01), improved ECG efficacy (RR=1.26, 95%CI[1.18, 1.35], P<0.000 01), angina pectoris efficacy (RR=1.26, 95%CI[1.20, 1.33], P<0.000 01), decreased triglyceride (MD=-0.57, 95%CI[-1.02, -0.12], P=0.01), total cholesterol (MD=-0.78, 95%CI[-1.15, -0.41], P<0.000 1), low-density lipoprotein cholesterol (MD=-0.58, 95%CI[-0.80, -0.36], P<0.000 01), raised high-density lipoprotein cholesterol (MD=0.24, 95%CI[0.08, 0.40], P=0.004), decreased whole blood viscosity (MD=-1.32, 95%CI[-2.25, -0.39], P=0.005), and plasma viscosity (MD=-0.29, 95%CI[-0.38,-0.21], P<0.000 01), fibrinogen (MD=-1.06, 95% CI[1.29, 0.83], P<0.000 01), lower C-reactive protein (MD=-1.70, 95% CI[2.33, 1.06], P<0.000 01), endothelin 1 (MD=-7.81, 95% CI[10.05, 5.57], P<0.000 01), and homocysteine (MD=-2.35, 95% CI[2.63, 2.07], P<0.000 01), improved the effect of nitric oxide (MD=8.74, 95%CI[7.00, 10.47], P<0.000 01), which was better than that of the pure western medicine group, and subgroup analysis results showed that the treatment course was greater than or equal to three months with better treatment. There was no statistically significant difference in the incidence of adverse reactions (P=0.56), liver and kidney function were not abnormal in all the studies. Conclusion Clinical application of Xinkeshu combined with conventional western medicine in the treatment of unstable angina pectoris is clear, which is recommended in clinical application.

R28;R541

国家重点研发计划“中医药现代化研究”重点专项（2018YFC1707402）；国家中医药管理局中医药循证能力建设项目（2019XZZX-XXG003）；河南省科技创新团队（C20130050）；河南省高校科技创新团队（131RTSTHN012）