参附注射液治疗射血分数降低的心力衰竭证据概述

Effects of heart failure with reduced ejection fraction with Shenfu Injection:a Meta-analysis and GRADE evaluation

[目的]系统评价参附注射液治疗射血分数降低的心力衰竭(HFrEF)的临床有效性和安全性,评价证据等级,为临床合理用药提供参考。[方法]计算机检索中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、万方数字化期刊全文数据库(WanFangData)、PubMed、Embase、The Cochrane Library数据库,收集参附注射液联合西医常规(治疗组)对比西医常规(对照组)治疗HFrEF的随机对照试验(RCT)采用风险评估工具(ROB)量表对文献信息进行质量评价,RevMan 5.3软件进行荟萃分析(Meta)分析,GRADE体系进行证据质量等级评价。[结果]共纳入21项RCT,包含患者1791例。Meta分析显示:参附注射液联合西医常规治疗在改善心功能(NYHA)[RR=1.17,95%CI(1.12,1.23),P<0.01]、改善生活质量[MD=-4.92,95%CI(-6.60,-3.24),P<0.01]、提高左室射血分数(LVEF)[MD=4.71,95%CI(3.16,6.27),P<0.01]、增加6分钟步行距离(6 MWD)[MD=44.17,95%CI(19.07,69.26),P<0.01]、降低B型利钠肽(BNP)[MD=-76.42,95%CI(-92.66,-60.18),P<0.01]/N末端B型利钠肽原(NT-proBNP)[MD=-182.23,95%CI(-274.07,-90.38),P<0.01]方面优于西医常规治疗,在不良事件[RR=1.06,95%CI(0.41,2.76),P=0.90]发生率方面与西医治疗相当。根据GRADE标准,纽约心脏病协会(NYHA)心功能分级改善率、6 MWD为低质量证据,明尼苏达心力衰竭生活量量表(MLHFQ)积分、LVEF、BNP、NT-proBNP、安全性为极低质量证据。[结论]参附注射液联合西医常规治疗HFrEF的疗效优于单用西医常规治疗,安全性良好,由于研究质量和数量的限制,尚需更多高质量的RCT加以验证。

[Objective]To analyze the clinical efficacy and safety of Shenfu Injection on heart failure with reduced ejection fraction(HFrEF),evaluate the evidence level and to provide reference for the rational clinical application of Shenfu Injection in clinical practice.[Methods]Collected randomized controlled trials(RCT)of the combined Western medicine routine of the Shenfu Injections(treatment group)compared to the Western medical routine(control group)for the treatment of HFrEF in the databases of CBM,CNKI,VIP,WANFANG DATA,PubMed,Embase,the Cochrane Library.Two researchers independently carried out literature screening and extracted the relevant data,and the quality evaluation were carried out by ROB scale.Meta-analysis were carried out by RevMan 5.3 software,and the quality of evidence was graded using the GRADE system.[Results]The 21 RCT literature were included,with 1791 patients.Meta-analysis result showed that Shenfu injection combined with Western medicine routine treatment can improve cardiac function(NYHA)[RR=1.17,95%CI(1.12,1.23),P<0.01],and improve quality of life[MD=-4.92,95%CI(-6.60,-3.24),P<0.01],improve LVEF[MD=4.71,95%CI(3.16,6.27),P<0.01],and increase 6-minute walk distance(6 MWD)[MD=44.17,95%CI(19.07,69.26),P<0.01],decrease type B Natriuretic peptide(BNP)[MD=-76.42,95%CI(-92.66,-60.18),P<0.01]/N-terminal B-type natriuretic peptide(NT-proBNP)[MD=-182.23,95%CI(-274.07,-90.38),P<0.01],and the curative effect was better than the Western medicine routine.As to adverse events[RR=1.06,95%CI(0.41,2.76),P=0.90],and the curative effect was equivalent to Western medicine routine.According the GRADE,NYHA cardiac function,6 MWD were low quality evidence,LVEF,Minnesota Living with Heart Failure Questionnaire(MLHFQ)score,BNP,NT-proBNP,safety were very low quality evidence.[Conclusion]The curative efficacy of treatment of HFrEF in the combination of Shenfu Injections and Western medicine was better than Western medicine routine,and the safety is good,and due to the low quality of the included research.The exact conclusion needs more high-quality research to be further verified.