丹红注射液治疗糖尿病合并冠心病的Meta分析

为系统评价丹红注射液联合常规治疗对比常规治疗,改善糖尿病合并冠心病的临床疗效与安全性。该研究通过中国知网、万方、维普、PubMed、Wed of Science、Cochrane Library,全面检索丹红注射液治疗糖尿病合并冠心病的随机对照试验(RCT)的中英文文献,限定时间为建库至2020年1月1日。严格按照纳排标准筛选文献,基于Jadad量表对纳入文献进行风险评估,采用Stata 12.0软件进行Meta分析。共纳入17篇RCTs文献,累计样本量1454例。Meta分析结果显示,丹红注射液联合常规治疗对比常规治疗在改善糖尿病合并冠心病的临床总有效率(RR=1.47,95%CI1.38,1.58],P<0.0001)、心电图有效率(RR=1.30,95%CI1.16,1.46],P<0.0001)、心绞痛有效率(RR=1.41,95%CI1.25,1.58],P<0.0001)、总胆固醇水平(SMD=-1.05,95%CI-1.95,-0.16],P=0.02)、低密度脂蛋白水平(SMD=-0.50,95%CI-0.79,-0.21],P<0.0001)、心绞痛发作频次(SMD=-3.71,95%CI-4.05,-3.36],P<0.0001)和心绞痛疼痛持续时间(SMD=-2.96,95%CI-3.25,-2.66],P<0.0001)方面差异具有统计学意义,但在改善空腹血糖(FPG)(SMD=-0.19,95%CI-0.45,0.08],P=0.16)、餐后2 h血糖(SMD=0.19,95%CI-0.11,0.49],P=0.22)、高密度脂蛋白水平(SMD=0.10,95%CI-0.30,0.49],P=0.62)试验组与对照组差异无统计学意义。与对照组相比,试验组的不良反应发生事件无统计学差异(SMD=-2.96,95%CI-3.25,-2.66],P=0.75)。结果表明,丹红注射液联合常规治疗可以提高糖尿病合并冠心病的临床疗效,且无明显不良反应。但鉴于参考文献证据级别较低,风险性较高,且存在一定的发表偏倚,尚需更多高质量、低偏倚的研究进一步证实。

Meta-analysis of Danhong Injection in treatment of diabetes mellitus complicated with coronary heart disease

To systematically evaluate the clinical efficacy and safety of Danhong Injection combined with conventional therapy in improving diabetes mellitus complicated with coronary heart disease.Based on the online literature database(CNKI,Wanfang,VIP,PubMed,Web of Science,Cochran Library),the Chinese and English papers about the randomized controlled trial(RCT)of Danhong Injection in the treatment of diabetes mellitus complicated with coronary heart disease were searched comprehensively from the establishment of the databases to January 1,2020.The papers were screened strictly according to the inclusion and exclusion criteria.Based on Jadad scale,the risk assessment of literature was carried out,and Meta-analysis was performed by STATA 12.0 software.Seventeen RCTs were included,involving 1453 patients.The results of Meta-analysis showed that the combination of Danhong Injection and conventio-nal treatment could improve the clinical comprehensive effective rate(RR=1.47,95%CI1.38,1.58],P<0.0001),electrocardiogram(ECG)efficiency(RR=1.30,95%CI1.16,1.46],P<0.0001),efficiency of the angina pectoris(RR=1.41,95%CI1.25,1.58],P<0.0001),cholesterol level(SMD=-1.05,95%CI-1.95,-0.16],P=0.02),low-density lipoprotein(LDL)level(SMD=-0.50,95%CI-0.79,-0.21],P<0.0001),coronary angina attack frequency(SMD=-3.71,95%CI-4.05,-3.36],P<0.0001)and duration of angina pectoris(SMD=-2.96,95%CI-3.25,-2.66],P<0.0001),with statistically significant differences.But the differences in fasting plasma glucose(FPG)(SMD=-0.19,95%CI-0.45,0.08],P=0.16),plasma glucose of two hours after meal(2hPG)(SMD=0.19,95%CI-0.11,0.49],P=0.22),and high-density lipoprotein(HDL)level(SMD=0.10,95%CI-0.30,0.49],P=0.62)after treatment were not statistically significant.Compared with the control group,there was no significant difference in adverse reactions(SMD=-2.96,95%CI-3.25,-2.66],P=0.75).The existing evidence shows that the combination of Western medicine and Danhong Injection can improve the clinical effect for diabetes mellitus complicated with coronary heart disease and has no obvious adverse reactions.However,due to the low level of overall literature evidence,high risk and some kind of publication bias,it still needs more high-quality randomized controlled trials and low-bias studies for further verification.