目的：评价银丹心脑通软胶囊联合常规疗法治疗2型糖尿病合并冠心病的疗效和安全性。方法：计算机系统检索中国生物医学文献数据库（CBMDisc）、《中国医学学术会议论文数据库》（CMAC）、中国期刊全文数据库（CNKI）、中文科技期刊全文数据库（VIP）、万方数据库、美国国立医学图书馆数据库（PubMed）、医学文摘数据库（EMbase）、美国科技信息所科学引文索引数据库（Web of Science），检索时限：建库至2013年12月。纳入银丹心脑通软胶囊联合常规疗法治疗2型糖尿病合并冠心病的随机对照试验（RCT）。由2位研究人员根据纳入与排除标准独立进行文献筛选、数据提取、质量评价并交叉核对结果，采用RevMan 5.1.0软件进行Meta分析。结果：共纳入9个RCT，共667例2型糖尿病合并冠心病患者。Meta分析结果显示银丹心脑通软胶囊联合常规疗法治疗心绞痛的有效率明显高于常规治疗组，其差异有统计学意义（OR=4.01，95%CI[2.37-6.79]），P<0.000 01，说明银丹心脑通软胶囊联合常规治疗能够控制心绞痛临床症状。由于纳入数据的限制，银丹心脑通软胶囊联合常规疗法控制心绞痛持续时间、心绞痛发作频率、空腹血糖有可能优于常规治疗组，两组治疗后比较差异有统计学意义。银丹心脑通软胶囊可改善冠心病合并2型糖尿病患者的血流变，降低血液高黏滞状态而起到治疗心绞痛的作用。结论：基于当前临床证据，银丹心脑通软胶囊治疗冠心病合并2型糖尿病的疗效优于常规治疗组，但研究结果具有一定局限性，尚需设计严格的大样本、多中心、双盲对照试验进一步验证。

This article was aimed to assess the effectiveness and safety of Yin-Dan Xin-Nao-Tong (YDXNT) Capsule combined with routine modern therapies for treatment of type-2 diabetes mellitus (T2MD) complicated with coronary heart disease (CHD). Databases including CBMDisc, CMAC, CNKI, VIP, Wanfang Data, PubMed, EMbase, and Web of Science were electronically searched from inception to December 2013. Randomized controlled trials (RCTs) on YDXNT capsule combined with routine modern therapies for treatment of T2MD complicated with CHD were included. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.1.0 software. The results showed that a total of 9 RCTs with 667 T2MD with CHD cases were included. The results of meta-analysis indicated that the total effective rate of YDXNT capsule combined with routine modern therapies was significant higher than the routine treatment for T2MD complicated with CHD treatment with statistical significance(OR = 4.01, 95%CI[2.37-6.79], P < 0.000 01). It showed that YDXNT capsule combined with routine modern therapies can control angina pectoris. Due to limitation of included data, controlling of the duration of angina pectoris, the attack frequency of angina pectoris, and fasting blood glucose, may be better than the routine treatment group with significant differences. YDXNT capsule can improve hemorheology indices and reduce high condensation state among CHD with T2DM patients in order to relieve angina pectoris. It was concluded that on the basis of current clinical evidences, YDXNT capsule had better treatment effect than the routine treatment group in the treatment of CHD with T2DM. However, the results have certain limitations. It still required double-blind multi-center RCTs with high quality, large samples for further verification.

国家中医药管理局2012年度国家中医临床研究基地业务建设科研专项（JDZX2012002）：中医干预2型糖尿病早期结局评价方法研究，负责人：杨骏；安徽中医药大学临床科学研究项目（2010LC-007A）：中医药治疗糖尿病合并冠心病疗效和安全性的系统评价，负责人：徐桂琴。