参附注射液治疗急性心力衰竭的Meta分析及GRADE评价

Effect of acute heart failure with Shenfu Injection: a Meta-analysis and GRADE evaluation

关键词:  参附注射液  急性心力衰竭  Meta分析  GRADE评价

Key words:  Shenfu Injection  acute heart failure  meta-analysis  GRADE evaluation

摘要:

[目的] 分析参附注射液治疗急性心力衰竭的临床有效性和安全性，进一步评价证据等级，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）、中国知网（CNKI）、维普数据库（VIP）、万方数据库（WanFangData）、PubMed、Embase、The Cochrane Library数据库，收集参附注射液联合西医常规疗法（治疗组）对比西医常规疗法（对照组）治疗急性心力衰竭的随机对照试验（RCT），采用风险评估量表（ROB量表）对文献信息进行质量评价，RevMan 5.3软件进行Meta分析，GRADE体系进行证据质量等级评价。[结果] 共纳入43项RCT，包含患者3 193例。Meta分析显示：参附注射液联合西医常规治疗在改善美国纽约心脏病协会（NYHA）心功能[RR=1.25，95%CI（1.19，1.31），P<0.01]、改善Killip心功能[RR=1.38，95%CI（1.24，1.53），P<0.01]、降低B型利钠肽（BNP）[MD=-266.83，95%CI（-337.73，-195.93），P<0.01]/N末端B型利钠肽原（NT-proBNP）[MD=-965.00，95%CI （-1 900.74，-29.26），P=0.04]、提高左心室射血分数（LVEF）[MD=6.35，95%CI（4.91，7.80），P<0.01]、改善生活质量[MD=-20.34，95%CI（-32.80，-7.88），P<0.01]、改善中医症状积分[MD=-1.60，95%CI（-2.59，-0.61），P<0.01]方面优于西医常规治疗，在减少尿量[MD=-35.95，95%CI（-137.11，65.21），P=0.49]、降低心力衰竭再住院率[RR=0.50，95%CI（0.05，5.23），P=0.56]方面与西医治疗相当，且未见严重不良反应。根据GRADE标准，中医症状积分为中等质量证据，Killip心功能分级改善率、尿量、心力衰竭再住院率为低质量证据，NYHA心功能分级改善率、BNP、NT-proBNP、LVEF、明尼苏达心力衰竭生活质量量表（MLHFQ）积分、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急性心力衰竭的疗效优于单用西医常规治疗，安全性良好，由于纳入研究的质量偏低，确切结论尚需更多高质量研究进一步验证。

Abstract:

[Objective] To Analysis the clinical efficacy and safety of Shenfu Injection on acute heart failure,further evaluate the evidence level,and to provide reference for the rational clinical applicate of Shenfu injection in clinical practice.[Methods] ollected 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 acute heart failure 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,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 total number of included literatures was 43,which were randomized controlled trails,with 3 193 patients. According tometa-analysis,Shenfu injection combined with western medicine routine treatment improve cardiac function (NYHA)[RR=1.25,95%CI(1.19,1.31),P<0.01] or (Killip)[RR=1.38,95%CI(1.24,1.53),P<0.01]),reduce BNP[MD=-266.83,95%CI(-337.73,-195.93),P<0.01] or NT-proBNP[MD=-965.00,95%CI(-1 900.74,-29.26),P=0.04],improve LVEF[MD=6.35,95%CI(4.91,7.80),P<0.01],improve quality of life[MD=-20.34,95%CI(-32.80,-7.88),P<0.01],improve TCM syndrome[MD=-1.60, 95%CI(-2.59,-0.61),P<0.01],the curative effect is better than the conventional treatment of western medicine. Reduce urine volume[MD=-35.95,95%CI(-137.11,65.21),P=0.49],reduce re-hospitalization rate of heart failure[RR=0.50,95%CI(0.05,5.23),P=0.56] the curative effect is equivalent to Western medicine treatment. And No significant adverse reactions were found in all studies. According the GRADE,TCM syndrome score is medium quality evidence,Killip cardiac function grade improvement rate,urine volume and heart failure re-hospitalization rate are low quality evidence,NYHA cardiac function grade improvement rate,BNP,NT-proBNP,LVEF,minnesota living with heart failure questionnaire (MLHFQ) score,safety are very low quality evidence.[Conclusion] The curative efficacy of treatment of acute heart failure in the combination of Shenfu Injections and Western medicine is better than the treatment of Western medicine,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.