芪苈强心胶囊辅助治疗扩张型心肌病的有效性与安全性的Meta分析  

Efficacy and Safety of Qili Qiangxin Capsules in the Adjuvant Treatment of Dilated Cardiomyopathy:A Meta-analysis

作　　者：冯娟 闫奎坡[2] 朱翠玲[2] 孙彦琴[2] 徐亚洲[2] 郭雨晴 李铖 FENG Juan;YAN Kuipo;ZHU Cuiling;SUN Yanqin;XU Yazhou;GUO Yuqing;LI Cheng(Henan University of Chinese Medicine,Zhengzhou 450000,China;Heart Center,The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China)

机构地区：[1]河南中医药大学,郑州450000 [2]河南中医药大学第一附属医院心脏中心,郑州450000

出　　处：《世界中医药》2022年第10期1396-1404,共9页World Chinese Medicine

基　　金：国家自然科学基金青年科学基金项目(81303073);河南中医学院一附院院内博士项目(2012KJ32);河南中医学院省属科研业务专项(2014KYYWF-YQ12);河南省科技攻关重点项目(112102310317);河南省高校科技创新团队支持计划(13IRTSTHN012);河南省中医药防治心血管疾病创新型科技团队(C20130050);国家人社部留学人员资助项目(人社函[2010]412号);河南省首批青苗人才培养项目(豫中医科教(2018)16号);河南省科技攻关项目(192102310161,182102310291);河南省中医药科学研究专项课题(2017ZY2017)。

摘　　要：目的:系统评价芪苈强心胶囊辅助治疗扩张型心肌病的疗效与安全性。方法:检索Cochrane Library、PubMed、EMBase、国家知识基础设施数据库(CNKI)、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD)、中国生物医学文献(CBM)数据库从建库至2020年8月已发表的芪苈强心胶囊治疗扩张型心肌病的随机对照试验。对纳入研究进行偏倚风险评估后,采用RevMan5.3软件进行Meta分析。结果:纳入16篇文章,1812例受试者;Meta分析显示,扩张型心肌病患者在西药常规治疗基础上加用芪苈强心胶囊后,能进一步提高心功能疗效(RR=0.35,95%CI为0.25~0.48,P<0.00001),降低血浆B型脑钠肽(BNP)水平(MD=-0.09,95%CI为-0.13~-0.05,P<0.0001),增加左室射血分数(LVEF)(MD=5.26,95%CI为3.69~6.82,P<0.00001)和6 min步行试验(6MWT)(MD=43.43,95%CI为39.78~47.08,P<0.00001),减少左室舒张期末内径(LVEDD)(MD=-4.48,95%CI为-5.85~-3.11,P<0.00001)和左室收缩期末内径(LVESD)(MD=-4.40,95%CI为-5.30~-3.49,P<0.00001);且亚组分析提示疗程可能与增加LVEF和降低LVESD相关。GRADE系统评价显示,心功能疗效为低质量,BNP、LVEF、LVEDD、LVESD、6MWT为极低质量。结论:芪苈强心胶囊联合西药治疗扩张型心肌病安全有效,能显著改善患者心功能和相关检查指标,进一步改善患者临床症状。由于纳入研究质量的限制,上述结论尚需更高水平的随机对照试验进一步验证。Objective:To systematically evaluate the efficacy and safety of Qili Qiangxin Capsules(QLQX)in the adjuvant treatment of dilated cardiomyopathy.Methods:The randomized controlled trials(RCTs)on QLQX in the treatment of dilated cardiomyopathy published from database inception to August 2020 were retrieved from Cochrane Library,PubMed,EMBase,CNKI,CSPD,CCD,and CBM.The included RCTs were assessed for risks of bias,followed by Meta-analysis by RevMan 5.3.Results:Sixteen articles were included,with 1812 subjects involved.As revealed by Meta-analysis,QLQX combined with western medicine further improved the cardiac function(RR=0.35,95%CI 0.25 to 0.48,P<0.00001),reduced the level of BNP(MD=-0.09,95%CI-0.13 to-0.05,P<0.0001],increased LVEF(MD=5.26,95%CI 3.69 to 6.82,P<0.00001)and 6MWT(MD=43.43,95%CI 39.78 to 47.08,P<0.00001),and reduced LVEDD(MD=-4.48,95%CI-5.85 to-3.11,P<0.00001)and LVESD(MD=-4.40,95%CI-5.30 to-3.49,P<0.00001).Subgroup analysis suggested that the course of treatment might be related to the increase in LVEF and the reduction of LVESD.GRADE system showed the efficacy of cardiac function was of low quality,BNP,LVEF,LVEDD,LVESD,and 6MWT were of very low quality.Conclusion:QLQX combined with western medicine is safe and effective in the treatment of dilated cardiomyopathy.It can significantly increase cardiac function,improve relevant inspection indexes,and further improve clinical symptoms.Due to the limited quality of the included RCTs,the above conclusion needs to be further verified by higher-level RCTs.

关 键 词：芪苈强心胶囊 扩张型心肌病 心功能 疗效 不良反应 中医药 META分析 

分 类 号：R289.5[医药卫生—方剂学] R541[医药卫生—中药学]