麝香保心丸联合常规西药治疗糖尿病冠心病的Meta分析

Meta-analysis of Shexiang Baoxin Pills Combined with Conventional Western Medicine in the Treatment of Diabetes Mellitus Complicated with Coronary Heart Disease

目的系统评价麝香保心丸联合常规西药治疗糖尿病冠心病的有效性与安全性。方法检索中国知网(CNKI)、维普中文期刊(VIP)、万方数据知识服务平台(Wanfang)、Pubmed、Cochrane Library、Embase等数据库自建库至2022年12月1日有关麝香保心丸联合常规西药治疗糖尿病冠心病的随机对照试验(RCT),按纳入及排除标准筛选文献,使用RevMan 5.4和Stata 14对纳入研究进行Meta分析,并用GRADE证据等级评价系统对结局指标进行评价。结果共纳入18项RCT,包括1569例患者,其中麝香保心丸联合常规西药组(试验组)799例,常规西药组(对照组)770例。与对照组比较,试验组可提高临床总有效率[RR=1.23,95%CI(1.15,1.32),P<0.00001]、心绞痛缓解有效率[RR=1.29,95%CI(1.03,1.61)、P=0.03]、心电图改善有效率[RR=1.51,95%CI(1.25,1.82),P<0.0001];降低空腹血糖[MD=-0.62,95%CI(-1.20,-0.05),P=0.03]、餐后2 h血糖[MD=-1.88,95%CI(-2.05,-1.70),P<0.00001];降低低密度脂蛋白[MD=-0.50,95%CI(-0.95,-0.05),P=0.03]、心绞痛发生次数[MD=-0.40,95%CI(-0.43,-0.36),P<0.00001]。但在糖化血红蛋白[MD=-0.27,95%CI(-0.72,0.18),P=0.24]、总胆固醇[MD=-0.55,95%CI(-1.11,-0.02),P=0.06]、不良反应发生率[RR=1.50,95%CI(0.25,8.85),P=0.65]方面,两组比较差异无统计学意义。GRADE证据等级评价:临床总有效率、心电图改善有效率、餐后2 h血糖、心绞痛发生次数为低质量证据,其余均为极低质量证据。结论麝香保心丸联合常规西药可进一步提高糖尿病冠心病的临床疗效,且安全性较好,但由于纳入研究及相关临床证据质量等级较低,需要更多高质量、大样本、多中心的随机对照试验进一步验证。

Objective To systematically evaluate the efficacy and safety of Shexiang Baoxin Pills combined with conventional western medicine in the treatment of diabetes mellitus complicated with coronary heart disease.Methods CNKI,VIP,Wanfang,Pubmed,Cochrane Library and Embase were searched for randomized controlled trials(RCTs)on Shexiang Baoxin Pills combined with conventional western medicine in the treatment of diabetes mellitus complicated with coronary heart disease.The search time was from the construction of databases to December 1,2022,and the final included articles were obtained after screening for inclusion and exclusion criteria.Meta-analysis of the included studies was conducted by using RevMan 5.4 and Stata 14.Finally,the outcome indicators were evaluated by the GRADE evidence level evaluation system.Results Eighteen RCTs involving a total of 1569 cases[799 cases in Shexiang Baoxin Pills+conventional western medicine group(trial group)and 770 cases in conventional western medicine group(control group)]were included.Compared with the control group,the trial group can improve the total clinical effective rate[RR=1.23,95%CI(1.15,1.32),P<0.00001],the effective rate of angina relief[RR=1.29,95%CI(1.03,1.61),P=0.03],the effective rate of ECG improvement[RR=1.51,95%CI(1.25,1.82),P<0.0001],and reduce fasting blood glucose(FBG)[MD=-0.62,95%CI(-1.20,-0.05),P=0.03],2-hour postprandial blood glucose(PBG)[MD=-1.88,95%CI(-2.05,-1.70),P<0.00001],lowdensity lipoprotein(LDL-C)[MD=-0.50,95%CI(-0.95,-0.05),P=0.03],frequency of angina occurrences[MD=-0.40,95%CI(-0.43,-0.36),P<0.00001].There was no significant difference in glycated hemoglobin(HbA1c)[MD=-0.27,95%CI(-0.72,0.18),P=0.24],total cholesterol(TC)[MD=-0.55,95%CI(-1.11,0.02),P=0.06],incidence of adverse reactions[RR=1.50,95%CI(0.25,8.85),P=0.65]between two groups.The GRADE evidence level evaluation showed that the total clinical effective rate,the effective rate of ECG improvement,PBG and frequency of angina occurrences were low quality evidence,while the rest were very-low certainty evidence.Conclusion Shexiang Baoxin Pills combined with conventional western medicine can improve the clinical efficacy of patients with diabetes mellitus complicated with coronary heart disease and the safety is good.Due to the low quality of the included studies and related clinical evidence,more high-quality,large-sample,and multi-center randomized controlled trials are needed for further verification.