参麦注射液联合右丙亚胺防治蒽环类药物心脏毒性的Meta分析及GRADE评价  

Shenmai Injection(参麦注射液) Combined with Dextropropimine for Anthracycline Cardiotoxicity:A Meta-analysis with GRADE Evaluation

作　　者：马腾[1] 朱明军 王永霞 李彬 郑超楠 贾梦楠 于丽 常鑫迪 MATeng;ZHU Mingjun;WANG Yongxia;LI Bin;ZHENG Chaonan;JIA Mengnan;YU Li;CHANG Xindi(Henan University of Chinese Medicine,Zhengzhou,450000;The First Affiliated Hospital of Henan University of Chinese Medicine)

机构地区：[1]河南中医药大学,河南省郑州市450000 [2]河南中医药大学第一附属医院

出　　处：《中医杂志》2021年第18期1598-1605,共8页Journal of Traditional Chinese Medicine

基　　金：国家重点研发计划重点专项课题(2019YFC1710000,2019YFC1710003);国家中医药管理局中医药循证能力建设项目(2019XZZX-XXG003);河南省科学技术厅河南省创新型科技人才队伍建设工程(C20130050)。

摘　　要：目的系统评价参麦注射液联合右丙亚胺对蒽环类药物心脏毒性的防治作用。方法检索中国知网、万方知识服务平台、维普网、PubMed、Cochrane Library数据库,收集参麦注射液联合右丙亚胺防治蒽环类药物心脏毒性的随机对照试验,检索时间范围为各数据库建库至2020年7月1日。由两位研究人员独立检索、筛选及资料提取,并对纳入的研究进行方法学质量评价,采用RevMan 5.3软件对结局指标(包括肌钙蛋白、左心室射血分数、心电图异常率、B型利钠肽、肌酸激酶同工酶)进行Meta分析。基于Meta分析结果,采用GRADE证据质量分级系统对结局指标的证据质量进行评级。结果共纳入10项研究,涉及613例患者,10项研究方法学质量均偏低。Meta分析结果显示:右丙亚胺联合参麦注射液在降低肌钙蛋白[SMD=-1.84,95%CI(-2.19,-1.50),P<0.00001]、血浆脑钠肽[MD=-33.70,95%CI(-36.94,-30.46),P<0.00001]、肌酸激酶同工酶[MD=-7.59,95%CI(-8.39,-6.79),P<0.00001],提高左心室射血分数[MD=13.52,95%CI(9.91,17.12),P<0.00001]、减少心电图异常率[RR=0.40,95%CI(0.29,0.55),P<0.00001]方面均优于单纯使用右丙亚胺组。安全性方面,试验组头晕、恶心呕吐等不良反应发生率与对照组相比差异无统计学意义(P=0.49)。参麦注射液联合右丙亚胺治疗蒽环类药物化疗后心脏毒性相关结局指标的证据质量评级为低级或极低级。结论参麦注射液联合右丙亚胺在防治蒽环类药物心脏毒性方面优于单纯使用右丙亚胺,但考虑到研究质量较低,此结论仍需更多高质量研究进行确证。Objective To systematically evaluate the effects of dexpropylimine combined with Shenmai injection(参麦注射液)on cardiotoxicity of anthracyclines.MethodsElectronic databases including CNKI,WanFang,VIP,PubMed,The Cochrane Library were searched for randomized controlled trials(RCTs)on dexpropylimine combined with Shenmai injection for anthracyclines cardiotoxicity,from the inception dates to July 1st,2020.Two researchers independently searched,screened and extracted data,as well as evaluated the methodological quality of the included studies.RevMan 5.3 software was used to perform meta-analyses of the outcomes including troponin,left ventricular ejection fraction(LVEF),abnormal electrocardiogram rate,B-type natriuretic peptide(BNP),creatine kinase isoenzyme.Based on the results of the meta-analysis,the GRADE system was used to rate the quality of evidence.ResultsA total of ten studies involving 613 patients were included,and the methodological quality of all the studies were assessed to be low.Results from the meta-analyses showed that dextropropimine combined with Shenmai injection was superior to detropropimine alone in reducing troponin(SMD=-1.84,95%CI(-2.19,-1.50),P<0.00001),BNP(MD=-33.70,95%CI(-36.94,-30.46),P<0.00001),CK-MB(MD=-7.59,95%CI(-8.39,-6.79),P<0.00001),improving LVEF(MD=13.52,95%CI(9.91,17.12),P<0.00001),and reducing the abnormal rate of electrocardiogram(RR=0.40,95%CI(0.29,0.55),P<0.00001).In terms of safety,there was no significantly statistical difference in the incidence of adverse reactions such as dizziness,nausea and vomiting between two groups(P=0.49).The quality of the evidence on Shenmai injection combined with dextropropylimine for anthracyclines cardiotoxicity-related outcomes were rated as low or very low.ConclusionDextroproimine combined with Shenmai injection is better than dextropromine alone in preventing and treating cardiotoxicity of anthracyclines.However,considering the low quality of the evidence,further high-quality researches are needed to confirm the conclusion.

关 键 词：参麦注射液 右丙亚胺 蒽环类药物 心脏毒性 META分析 GRADE评价 

分 类 号：R730.5[医药卫生—肿瘤]