养心氏片治疗慢性心力衰竭疗效及安全性的Meta分析

Efficacy and Safety of Yangxinshi Tablets in the Treatment of Chronic Heart Failure:a Meta Analysis

目的系统评价养心氏片辅助治疗慢性心力衰竭(CHF)的临床疗效及安全性。方法计算机检索各大数据库,检索时限为建库至2017年6月,纳入养心氏联合常规西药与常规西药治疗慢性心力衰竭的临床随机对照试验。由2名研究者独立检索文献,经Jadad改良版质量评价后纳入文献,采用Reviews Manger 5.3软件进行Meta分析。结果共纳入14个研究,全部为中文文献,Jadad评分1篇为2分,13篇为1分。Meta分析结果显示,试验组与对照组比较,试验组可提高病人临床疗效,OR=3.24,95%CI[2.33,4.49],P<0.000 01;提高6 min步行距离(6MWT),平均差(MD)=47.21,95%CI[37.45,56.97],P<0.000 01;降低N末端脑钠肽前体(NT-proBNP),标准化均数差(SMD)=-1.57,95%CI[-2.50,-0.63],P=0.001;降低超敏C反应蛋白(hs-CRP),MD=-0.39,95%CI[-0.80,0.02],P=0.06。服用养心氏片后,个别病例出现干咳、上腹部不适、胃胀等不良反应,均可耐受,与对照组比较,差异无统计学意义(P>0.05)。结论养心氏片辅助治疗慢性心力衰竭,可改善心功能,但现有文献质量偏低,确切结论仍需进一步严格试验证实。

Objective To evaluate the clinical efficacy and safety of Yangxinshi tablets in the adjuvant treatment of chronic heart failure（CHF）.Methods We searched the databases.The retrieval time was up to November 2017,the clinical randomized controlled trials（RCTs）about the efficacy of Yangxinshi tablets plus conventional western medicine versus western medicine in the treatment of CHFwere collected.Meta analysis was performed using Reviews Manger 5.3 software for Meta analysis after data extraction independentlyby 2 researchers and quality evaluation by modified Jadad.Results The results of 14 studies were included,all of them in Chinese,of which Jadad score was 2 in 1 article and 1 in 13 articles.Meta analysis showed that compared with control group,Yangxinshitablets improved the clinical efficacy[OR=3.24,95% CI （2.33,4.49）,P 〈0.000 01],improved the 6 min walking distance（6 MWT）[MD=47.21,95% CI （37.45,56.97）,P 〈0.000 01],reduced the levels of N terminal pro B type natriuretic peptide （NT proBNP）[SMD=-1.57,95% CI （-2.50,-0.63）,P =0.001],lowered the levels of high sensitivity C reactive protein （hs CRP）[MD=-0.39,95%CI （-0.80,0.02）,P =0.06].There was no significant difference in the adverse reactions between two groups （P 〉0.05）.ConclusionYangxinshi tablets in the adjuvant treatment of CHF can improve cardiac function.The existing literature quality is poor,the exactconclusion still needs further rigorous trials.