丹参多酚酸盐注射液联合常规西药治疗冠心病心力衰竭有效性及安全性的Meta分析

A Meta-analysis of the Efficacy and Safety of Danshen Polyphenolate Injection Combined with Conventional Western Medicine in the Treatment of Coronary Heart Disease Complicated with Heart Failure

目的系统评价丹参多酚酸盐注射液联合常规西药治疗冠心病心力衰竭的有效性与安全性。方法系统检索中国知网(CNKI)、万方数据知识服务平台(Wanfang)、维普中文期刊(VIP)、Pubmed、Cochrane Library、Embase等数据库中有关丹参多酚酸盐注射液联合常规西药治疗冠心病心力衰竭的随机对照试验(RCT),时间为建库至2023年1月1日。使用RevMan 5.4对纳入研究进行Meta分析。通过GRADE证据等级评价系统对结局指标进行评价。结果最终纳入13项研究,总样本量1648例,其中试验组832例,对照组816例。Meta分析结果显示,在常规西药治疗的基础上,联合使用丹参多酚酸盐注射液可以进一步提高冠心病心力衰竭患者的临床总有效率[RR=1.20,95%CI(1.15,1.26),P<0.00001]、左室射血分数(LVEF)[MD=5.97,95%CI(4.59,7.34)、P<0.00001]、每搏量(SV)[MD=10.75,95%CI(7.22,13.78),P<0.00001]、心输出量(CO)[MD=0.94,95%CI(0.53,1.34),P<0.00001]、心脏指数(CI)[MD=1.12,95%CI(1.00,1.25),P<0.00001],缩小左室舒张末期内径(LVEDD)[MD=-8.34,95%CI(-12.81,-3.86),P=0.0003]、左室收缩末期内径(LVESD)[MD=-10.49,95%CI(-16.44,-4.54),P=0.0006],增加6 min步行试验(6MWT)水平[MD=47.11,95%CI(38.33,55.88),P<0.00001],降低血清心型脂肪酸结合蛋白(H-FABP)[MD=-10.16,95%CI(-12.39,-7.94),P<0.00001]和Lee心衰评分[MD=-1.73,95%CI(-1.88,-1.58),P=0.02]。GRADE证据等级评价临床总有效率、CI、6MWT、H-FABP为低质量证据,LVEF、LVEDD、LVESD、SV、CO、Lee心衰评分、不良反应发生率评价为极低质量证据。结论丹参多酚酸盐注射液联合常规西药治疗可以有效改善冠心病心力衰竭患者临床总有效率及心功能指标,且不会增加不良反应的发生,但纳入文献及相关临床证据等级质量较低,期待开展更多高质量、大样本随机对照试验进一步验证。

Objective To systematically evaluate the efficacy and safety of Danshen Polyphenolate Injection combined with conventional western medicine in the treatment of coronary heart disease complicated with heart failure.Methods Randomized controlled trials(RCTs)on Danshen Polyphenolate Injection combined with conventional western medicine in the treatment of coronary heart disease complicated with heart failure were systematically searched from CNKI,Wanfang,VIP,Pubmed,Cochrane Library,Embase and other databases(database establishment-January 1,2023).Included studies were used for Meta-analysis on RevMan5.4 software.Outcome measures were assessed using the GRADE system of rating the quality of evidence.Results Finally,13 articles with a total sample size of 1648 cases(832 cases in the experimental group and 816 cases in the control group,respectively)were included.The results of Meta-analysis showed that Danshen Polyphenolate Injection combined with conventional western medical treatment could further improve the total clinical response rate of patients with coronary heart failure[RR=1.20,95%CI(1.15,1.26),P<0.00001],left ventricular ejection fraction(LVEF)[MD=5.97,95%CI(4.59,7.34),P<0.00001],stroke volume(SV)[MD=10.75,95%CI(7.22,13.78),P<0.00001],cardiac output(CO)[MD=0.94,95%CI(0.53,1.34),P<0.00001]and cardiac index(CI)[MD=1.12,95%CI(1.00,1.25),P<0.00001],reduce left ventricular end-diastolic diameter(LVEDD)[MD=-8.34,95%CI(-12.81,-3.86),P=0.0003]and left ventricular end-systolic diameter(LVESD)[MD=-10.49,95%CI(-16.44,-4.54),P=0.0006],increase 6-minute walk test level(6MWT)[MD=47.11,95%CI(38.33,55.88),P<0.00001],decrease serum heart-type fatty acid-binding protein(H-FABP)[MD=-10.16,95%CI(-12.39,-7.94),P<0.00001]and Lee's heart failure score[MD=-1.73,95%CI(-1.88,-1.58),P=0.02].According to the GRADE system,clinical total response rate,CI,6MWT,H-FABP are low-certainty evidence.Moreover,LVEF,LVEDD,LVESD,SV,CO,Lee's heart failure scores,and adverse event incidence are very low-certainty evidence.Conclusion Danshen Polyphenolate Injection combined with conventional western medicine treatment can effectively improve the total clinical response rate and cardiac function indexes of patients with coronary heart failure.It was also found that this treatment did not increase the occurrence of adverse reactions.Due to the low quality of the included literature and related clinical evidence,and it is expected that more high-.quality,large-sample randomized controlled trials should be carried out for further verification.