摘要
目的系统评价通心络胶囊治疗糖尿病心肌病(DCM)的临床疗效。方法计算机检索PubMed、EMbase、Ovid Cochrane、中国期刊全文数据库(CNKI)、万方数据知识服务平台(WanFang Data)、维普中文期刊数据库(VIP)、中国生物医学文献数据库(CBM)、中国生物文献服务系统、中国博士学位论文全文数据库、中国优秀硕士生学位论文全文数据库,同时手工检索及向药厂索要相关资料,全面收集使用通心络胶囊治疗DCM病人的所有随机对照试验,检索时限均为从建库至2020年1月。由两名评价者独立进行文献筛选、提取资料和风险偏倚评价,然后采用RevMan 5.3软件进行Meta分析,并系统评价各研究结果。结果共纳入11项研究,共766例病人,均为非安慰剂随机对照研究,研究质量总体不高。试验组总有效率高于对照组[OR=4.64,95%CI(2.91,7.40),Z=6.43,P<0.00001]。心功能方面,疗程4周试验组射血分数[MD=3.99,95%CI(3.39,4.59),Z=13.02,P<0.00001]、左室短轴缩短率[MD=2.92,95%CI(0.83,5.02),Z=2.74,P=0.006]、舒张早期充盈峰值流速[MD=0.14,95%CI(0.09,0.19),Z=5.29,P<0.00001]高于对照组,舒张晚期充盈峰值流速低于对照组[MD=-0.14,95%CI(-0.17,-0.10),Z=6.88,P<0.00001];每次2~4粒服用的试验组二尖瓣舒张早期的血流速度与心房收缩期峰值血流速度的比值(E/A)高于对照组[MD=0.28,95%CI(0.25,0.31),Z=17.53,P<0.00001],每次3粒服用的试验组E/A高于对照组[MD=0.26,95%CI(0.22,0.30),Z=11.48,P<0.00001]。心脏结构方面,疗程4周试验组左室舒张末内径[MD=-6.90,95%CI(-8.41,-5.40),Z=8.99,P<0.00001]、左房内径[MD=-2.16,95%CI(-2.79,-1.53),Z=6.73,P<0.00001]、室间隔舒张末厚度[MD=-0.76,95%CI(-1.06,-0.45),Z=4.87,P<0.00001]均低于对照组,每次2~4粒服用的试验组左室后壁舒张末厚度低于对照组[MD=-1.40,95%CI(-1.80,-1.00),Z=6.88,P<0.00001]。血液流变学方面,试验组全血黏度[MD=-0.95,95%CI(-1.15,-0.74),Z=9.07,P<0.0001]、血浆黏度[MD=-0.08,95%CI(-0.13,-0.04),Z=3.86,P=0.0001]、纤维蛋白原[MD=-0.26,95%CI(-0.31,-0.22),Z=11.36,P<0.00001]均低于对照组。血糖方面,试验组空腹血糖[MD=-0.92,95%CI(-1.05,-0.78),Z=13.22,P<0.00001]、餐后血糖[MD=-1.52,95%CI(-1.63,-1.42),Z=28.77,P<0.00001]、糖化血红蛋白[MD=-1.15,95%CI(-1.27,-1.03),Z=18.52,P<0.00001]均低于对照组。结论当前证据表明,在常规治疗基础上加用通心络胶囊能明显改善DCM病人临床症状、心功能、心脏结构、血液流变学及血糖等指标。
Objective To evaluate the clinical effect of Tongxinluo capsule on diabetic cardiomyopathy.Methods Randomized controlled trials(RCTs)for Tongxinluo capsule treatment of diabetic cardiomyopathy were retrieved by electronically and manually searching databases and claimed from pharmaceutical factories.Pubmed,Embase,Ovid,Cochrane,CNKI,WanFang Data,VIP,CBM,Chinese biological literature service system,PhD thesis Chinese full text database,and China excellent postgraduate dissertations full-text database.The retrieval time was were retrieved from the database construction to January 2020.Data were extracted and evaluated by two independent evaluators.RevMan 5.3 software was used for Meta-analysis.Results A total of 11 studies were included,with a total of 766 patients,all of which were non-placebo randomized controlled trials.The overall quality of the study was not high.The total effective rate of Tongxinluo group was higher than that of control group[OR=4.64,95%CI(2.91,7.40),Z=6.43,P<0.00001];Cardiac function,and ejection fraction in Tongxinluo group were higher than that in control group[MD=3.99,95%CI(3.39,4.59),Z=13.02,P<0.00001],fractional shortening in Tongxinluo group was higher than that in control group[MD=2.92,95%CI(0.83,5.02),Z=2.74,P=0.006],PA in Tongxinluo group was lower than that in control group after 4-week treatment[MD=-0.14,95%CI(-0.17,-0.10),Z=6.88,P<0.00001],E/A in Tongxinluo group by taking 2~4 tablets at a time was lower than that in control group[MD=0.28,95%CI(0.25,0.31),Z=17.53,P<0.00001],E/A in Tongxinluo group by taking 3 tablets at a time was higher than that in control group[MD=0.26,95%CI(0.22,0.30),Z=11.48,P<0.00001].In terms of cardiac structure,LVEDd in Tongxinluo group was higher than that in control group for 4 weeks[MD=-6.90,95%CI(-7.41,-5.40),Z=8.99,P<0.00001],LA in Tongxinluo group was lower than that in control group[MD=-2.16,95%CI(-2.79,-1.53),Z=6.73,P<0.00001],IVSd in Tongxinluo group was lower than that in control group[MD=-0.76,95%CI(-1.06,-0.45),Z=4.87,P<0.00001],The LVPWd of Tongxinluo group by taking 2~4 tablets at a time was lower than that of control group[MD=-1.40,95%CI(-1.80,-1.00),Z=6.88,P<0.00001].The whole blood viscosity of Tongxinluo group was lower than that of control group[MD=-0.95,95%CI(-1.15,-0.74),Z=9.07,P<0.0001],the plasma viscosity of Tongxinluo group was lower than that of control group[MD=-0.08,95%CI(-0.13,-0.04),Z=3.86,P<0.00001],fibrinogen in Tongxinluo group was lower than that in control group[MD=-0.26,95%CI(-0.31,-0.22),Z=11.36,P<0.00001].FBG in Tongxinluo group was lower than that in control group[MD=-0.92,95%CI(-1.05,-0.78),Z=13.22,P<0.00001],PBG in Tongxinluo group was lower than that in control group[MD=-1.52,95%CI(-1.63,-1.42),Z=28.77,P<0.00001],HbA1c in Tongxinluo group was lower than that in control group[MD=-1.15,95%CI(-1.27,-1.03),Z=18.52,P<0.00001].Conclusion Compared with other treatment schemes,rofine therapy with Tongxinluo capsule can significantly improve the clinical symptoms,cardiac function,cardiac structure,hemorheology,and blood glucose in patients with diabetic cardiomyopathy.
作者
黄宏
李玉峰
肖珉
修晟尧
姜旭
HUANG Hong;LI Yufeng;XIAO Min;XIU Shengyao;JIANG Xu(Nanjing University of Chinese Medicine,Nanjing 210029,Jiangsu,China)
出处
《中西医结合心脑血管病杂志》
2020年第9期1352-1362,共11页
Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease
关键词
糖尿病心肌病
通心络胶囊
射血分数
左室内径
全血黏度
血红蛋白
Meta分析
随机对照试验
diabetic cardiomyopathy
Tongxinluo capsule
ejection fraction
left ventricular
whole blood viscosity
hemoglobin
meta analysis
randomized controlled trial
