参附强心丸治疗心力衰竭有效性及安全性的Meta分析

Efficacy and Safety of Shenfu Qiangxin Pills in the Treatment of Heart Failure:a Meta-analysis

目的系统评价参附强心丸治疗心力衰竭的有效性及安全性。方法检索万方数据库、中国知网数据库、维普中文科技期刊数据库、中国生物医学文献数据库、EMbase、PubMed、The Cochrane Library、ClinicalTrials.gov共8个数据库,检索时间为建库至2020年11月1日,纳入参附强心丸治疗心力衰竭的随机对照试验(RCT)。采用Cochrane协作网提供的风险偏倚评估工具对纳入的文献进行方法学质量评价,对纳入研究进行描述性分析,并应用RevMan 5.3软件进行Meta分析。结果共纳入10项RCT,共893例病人,其中治疗组448例、对照组445例。Meta分析结果显示:与对照组比较,治疗组可提高总有效率[RR=1.24,95%CI(1.16,1.33),P<0.00001]、左室射血分数[MD=5.25,95%CI(3.96,6.55),P<0.00001]和6min步行试验[MD=36.04,95%CI(19.63,52.45),P<0.0001],缩小左室舒张末期内径[SMD=-1.02,95%CI(-1.19,-0.86),P<0.00001]和左室收缩末期内径[MD=-4.91,95%CI(-5.51,-4.32),P<0.00001],降低B型脑钠肽[SMD=-2.81,95%CI(-3.15,-2.47),P<0.00001]和明尼苏达心力衰竭生活质量调查表积分[MD=-6.11,95%CI(-8.05,-4.18),P<0.00001]。两组均未见严重不良反应。结论现有证据表明:参附强心丸联合西医治疗心力衰竭有一定疗效,未见严重不良反应。

Objective To systematically evaluate the efficacy and safety of Shenfu Qiangxin Pills in the treatment of heart failure.Methods Wanfang Data Resource System Data,China National Knowledge Infrastructure,Chinese science and technology periodical database,Chinese Biomedical Literature Service System,EMbase,PubMed,The Cochrane Library,ClinicalTrials.gov were searched to collect randomized controlled trials(RCTs)of Shenfu Qiangxin Pills in the treatment of heart failure from the establishment to November 1,2020.The risk bias assessment tool provided by the Cochrane Collaboration was used to evaluate the methodological quality of the includedliteratures,descriptive analysis was performed on the included studies,and RevMan 5.3 software was used for Meta-analysis.Results A total of 10 literatures were included,involving 893 patients,448 cases in the treatment group and 445 cases in the controlgroup.The results of Meta-analysis showed that compared with the control group,the clinical efficacy in the treatment group[RR=1.24,95%CI(1.16,1.33),P<0.00001],left ventricular ejection fraction[MD=5.25,95%CI(3.96,6.55),P<0.00001]and 6 min walking test[MD=36.04,95%CI(19.63,52.45),P<0.0001]increased,the left ventricular end diastolic diameter[SMD=-1.02,95%CI(-1.19,-0.86),P<0.00001]and left ventricular end systolic diameter[MD=-4.91,95%CI(-5.51,-4.32),P<0.00001],and B-type brain natruretic peptide[SMD=-2.81,95%CI(-3.15,-2.47),P<0.00001]and Minnesota Heart Failure Quality of Life Questionnaire scores[MD=-6.11,95%CI(-8.05,-4.18),P<0.00001]decreased.No serious adverse reactions were observed in both groups.Conclusion Current evidence showed that Shenfu Qiangxin Pills combined with western medicine could treat heart failure without adverse reactions.