通心络胶囊联合常规疗法治疗糖尿病合并冠心病的系统评价及序贯分析

Systematic Evaluation and Sequential Analysis of Tongxinluo Capsule Combined with Conventional Therapy in the Treatment of Diabetes Mellitus Complicated with Coronary Heart Disease

目的系统评价通心络胶囊联合常规疗法治疗糖尿病合并冠心病的临床疗效及安全性。方法使用计算机对CNKI,WanFang,VIP,CBM,PubMed,Web of science,Cochrane library数据库进行检索,检索时间为建库至2021年7月,全面收集通心络胶囊联合常规疗法治疗糖尿病合并病冠心病的随机对照试验。研究者严格按照已制定的纳排标准进行文献筛选、资料提取及文献质量评价,采用RevMan 5.4.1软件进行Meta分析,GRADE profiler3.6.1软件进行证据质量评价,TSA 0.9.5.10 Beta软件进行序贯分析。结果共纳入14项临床研究,涉及1164例患者。Meta分析显示,通心络胶囊联合常规疗法相较于单纯西医治疗在提高糖尿病合并冠心病患者的临床总有效率(RR=1.44,95%CI[1.22,1.70],P<0.05),提高心绞痛缓解有效率(RR=1.46,95%CI[1.29,1.67],P<0.05),提高心电图改变有效率(RR=1.50,95%CI[1.31,1.72],P<0.05),降低空腹血糖(MD=-0.83,95%CI[-1.11,-0.54],P<0.05),降低糖化血红蛋白(MD=-0.50,95%CI[-0.82,-0.19],P<0.05),降低总胆固醇(MD=-0.60,95%CI[-0.97,-0.23],P<0.05),降低甘油三酯(MD=-0.74,95%CI[-1.05,-0.43],P<0.05),提高高密度脂蛋白(MD=0.26,95%CI[0.20,0.32],P<0.05),降低低密度脂蛋白(MD=-0.34,95%CI[-0.57,-0.12],P<0.05)方面差异有统计学意义,在降低餐后2 h血糖(MD=-0.18,95%CI[-1.71,1.35],P>0.05)方面差异无统计学意义。试验序贯分析显示,临床总有效率累计纳入的研究超过了传统界值和TSA界值,进一步肯定了其临床疗效。结论通心络胶囊联合常规疗法相较于单纯常规治疗改善糖尿病合并冠心病的临床症状及相关指标更显著,且安全性较好。但受限于纳入文献的数量和质量,所得结论仍需更多大样本、多中心的随机对照试验进一步验证。

Objective To systematically evaluate the clinical efficacy and safety of Tongxinluo capsule combined with conventional therapy in the treatment of diabetes mellitus complicated with coronary heart disease. Methods The databases of CNKI, Wan Fang, VIP, CBM, PubMed, Web of science, Cochrane Library were searched by computer from the establishment to July 2021, and randomized controlled trials of Tongxinluo capsule combined with conventional western medicine for treatment of diabetes mellitus complicated with coronary heart disease were comprehensively collected. The researchers conducted literature screening in strictly stablished inclusion and exclusion criteria, data extraction and literature quality evaluation. RevMan 5.4.1 software was used for meta-analysis. GRADE profiler3.6.1software was used to evaluate the quality of evidence, and TSA 0.9.5.10 Beta software was used for sequential analysis.Results A total of 1164 patients were included in fourteen clinical studies. The results of meta-analysis showed that compared with conventional therapy, Tongxinluo capsule combined with conventional therapy can improve the clinical total effective rate of diabetic patients with coronary heart disease(RR=1.44, 95%CI [1.22, 1.70], P<0.05), improve the effective rate of angina relief(RR=1.46, 95%CI [1.29, 1.67], P<0.05), improve the effective rate of ECG change(RR=1.50, 95%CI [1.31, 1.72], P<0.05), reduce the fasting blood glucose(MD=-0.83, 95%CI [-1.11,-0.54], P<0.05), reduce the glycosylated hemoglobin(MD=-0.50, 95%CI [-0.82,-0.19], P<0.05), reduce the total cholesterol(MD=-0.60,95%CI [-0.97,-0.23], P<0.05), reduce the triglycerides(MD=-0.74, 95%CI [-1.05,-0.43], P<0.05), improve the high density lipoprotein(MD=0.26, 95%CI [0.20, 0.32], P<0.05), reduce the low density lipoprotein(MD=-0.34, 95%CI [-0.57,-0.12], P<0.05) with statistically significant differences. However, compared with the control group, the difference in reducing 2 h postprandial blood glucose(MD=-0.18, 95%CI [-1.71, 1.35], P>0.05) after treatment was not statistically significant. Sequential analysis of the trails showed that the studies accumulatively included for the clinical total effective rate passed the traditional threshold and the TSA threshold, further affirming its clinical efficacy.Conclusion Tongxinluo capsule combined with conventional therapy can improve the clinical symptoms and related indexes of diabetes mellitus complicated with coronary heart disease, which is better than that of conventional treatment alone, without obvious adverse reactions. However, due to the limits of the quantity and quality of the literatures included in the study, the conclusion still needs to be further confirmed by more high-quality, multi-center and strictly designed clinical randomized controlled trials.