芪苈强心胶囊对射血分数保留心力衰竭患者生活质量影响的Meta分析

Effect of Qili Qiangxin Capsule for heart failure with preserved ejection fraction on quality of life:a meta-analysis

关键词:  芪苈强心胶囊  射血分数保留心力衰竭  Meta分析  GRADE评价

Key words:  Qili Qiangxin Capsule  ejection fraction preserved heart failure  meta-analysis  systematic review  GRADE

摘要:

[目的] 系统评价芪苈强心胶囊对射血分数保留心力衰竭（HFpEF）患者生活质量影响的有效性及安全性，并对证据质量等级进行评价。[方法] 计算机检索中国知网数据库（CNKI）、万方数据库（WanFang Data）、维普资讯中文科技期刊数据库（VIP）、中国生物医学文献数据库（SinoMed）、PubMed、Embase和Cochrane Library共7个中英文数据库，收集芪苈强心胶囊治疗HFpEF的临床随机对照试验（RCT），检索时限均从建库至2020年8月1日。采用Cochrance偏倚风险评估工具对纳入研究进行方法学质量评价，利用RevMan 5.3软件进行Meta分析及发表偏倚评估。最后根据GRADE标准对证据级别进行评价。[结果] 共纳入26项RCT，2221例HFpEF患者。Meta分析结果显示芪苈强心胶囊组在提高HFpEF患者临床综合疗效[RR=1.24，95%CI（1.18，1.31），P<0.00001]、改善中医证候疗效[RR=1.18，95%CI（1.05，1.32），P=0.005]、降低明尼苏达心力衰竭生活质量量表评分[WMD=-8.70，95%CI（-10.24，-7.17），P<0.0001]、增加6 min步行距离[WMD=58.78，95％CI（38.79，78.76），P<0.00001]、提高左室射血分数[WMD=4.06，95％CI（3.12，5.00），P<0.00001]、降低舒张早期二尖瓣瓣口血流峰值速度/二尖瓣环舒张早期运动速度[WMD=-2.70，95％CI（-3.52，-1.88），P<0.00001]、降低左心房容积指数[WMD=-5.68，95%CI（-6.83，-4.53），P<0.00001]方面疗效显著。不良反应发生率方面，两组比较无统计学差异（P>0.05）。基于GRADE标准，“降低明尼苏达心力衰竭生活质量量表评分”“降低舒张早期二尖瓣瓣口血流峰值速度/二尖瓣环舒张早期运动速度”“降低左心房容积指数”“不增加不良反应发生率”被评为中等质量证据；“提高临床综合疗效”“改善中医证候疗效”“增加6 min步行距离”“提高左室射血分数”被评为低质量证据。[结论] 芪苈强心胶囊联合西医常规治疗在改善HFpEF患者的临床症状、提高运动耐量及心脏舒张功能方面确有疗效，且未见不良反应增加。鉴于GRADE评价证据质量为中等或低质量，对于研究结果的应用还应谨慎。

Abstract:

[Objective] To systematically evaluate the effect of Qili Qiangxin Capsule combined with conventional western medicine on quality of life in patients with ejection fraction preserved heart failure (HFpEF). [Methods] Clinical randomized controlled trials (RCTs) of Qili Qiangxin Capsule for treating preserved heart failure were systematically identified in electronic databases including CNKI,Wanfang,VIP,SinoMed,PubMed,Embase,and Cochrane Library. The Cochrane's risk of bias tool was used to evaluate the methodological quality of the included studies,the RevMan 5.3 software was used for meta-analysis,the Stata 15.0 software was used to evaluate publication bias,and the quality of evidence was graded according to the guidelines of the Grading of Recommendations Assessment,Development and Evaluation (GRADE) system. [Results] A total of 26 RCTs involving 2 221 patients were finally included. The study showed that,compared with conventional therapy alone,Qili Qiangxin Capsule combined with conventional therapy has a statistically significant difference in comprehensive clinical efficacy(RR=1.24,95%CI[1.18,1.31],P<0.000 01),therapeutic effect of traditional Chinese medicine syndrome (RR=1.18,95%CI[1.05,1.32],P=0.005),quality of life(WMD=-8.70,95%CI[-10.24,-7.17], P<0.0001),6 min walking distance (WMD=58.78,95%CI[38.79,78.76],P<0.000 01),left ventricular ejection fraction (WMD=4.06, 95%CI[3.12,5.00],P<0.000 01),E/e'(WMD=-2.70,95%CI[-3.52,-1.88],P<0.000 01),LAVI (WMD=58.78,95%[38.79,78.76],P<0.000 01) in patients with preserved ejection fraction on quality of life heart failure;there is no significant difference in drug-related adverse reactions. According to GRADE standard,quality of life,E/e',LAVI and incidence of adverse reactions were medium quality evidence,comprehensive clinical efficacy,therapeutic effect of traditional Chinese medicine syndrome,6 min walking distance and left ventricular ejection fraction were low-quality evidence. [Conclusion] Qili Qiangxin Capsule combined with conventional Western medicine treatment can improve the quality of life of HFpEF patients,there is no significant difference in drug-related adverse reactions.However,due to the low quality of evidence,the end-point indicators are less concerned.