补阳还五汤加减治疗慢性心衰临床疗效的系统评价及试验序贯分析

Systematic Review and Sequential Analysis on Efficacy of Modified Buyang Huanwu Tang in Treatment of Chronic Heart Failure

目的:系统评价补阳还五汤加减治疗慢性心力衰竭的有效性及安全性。方法:系统检索中文数据库CNKI数据库、万方数据库、维普数据库,外文数据库Pubmed,Medline,Embase及Corchrane数据库。文献检索期限为数据库收录最早至2019年12月,以"补阳还五汤""慢性心力衰竭""心力衰竭"作为关键词全文检索中英文数据库。纳入补阳还五汤加减加西医基础治疗对照西医基础治疗治疗慢性心力衰竭的随机对照试验(randomized controlled trials,RCTs)文献,提取资料。用Cochrane系统评价的方法对文献质量进行评分,采用Stata14.0软件对纳入的研究结果进行Meta分析,并用TSA0.9软件进行试验序贯分析。对异质性采用敏感性分析,做出合理解释;发表偏倚采用倒漏斗图进行评估。结果:共纳入21项RCT研究2 037例患者,文章质量风险评估普遍为Unclear risk of bias,Meta分析结果显示,与对照组比较,试验组左室射血分数(LVEF)明显高于对照组,差异具有统计学意义[MD=0.901,95%CI(0.772,1.029),P<0.01];试验组左心室舒张末期内径(LVEDD)明显低于对照组,差异具有统计学意义[OR=-0.650,95%CI=(-0.854,-0.446),P<0.01];试验组BNP明显低于对照组,差异具有统计学意义[MD=-1.212,95%CI=(-1.359,-1.066),P<0.01];试验组6分钟步行试验(6MWT)明显高于对照组,差异具有统计学意义[MD=0.797,95%CI=(0.447,1.146),P<0.01];试验组有效率显著提高,差异具有统计学意义[OR=1.840,95%CI=(1.680,2.016),P<0.01]。结论:补阳还五汤加减在常规西药治疗基础上治疗慢性心力衰竭疗效优于单纯应用西药治疗,可以提高临床有效率,且能有效提高慢性心衰患者的LVEF,缩小LVEDD,降低血浆BNP水平,延长6分钟步行距离,减少不良反应的发生率。

Objective: To systematically evaluate the efficacy and safety of modified Buyang Huanwu Tang in the treatment of chronic heart failure. Method: CNKI database,Wanfang database,VIP database,Pubmed,MEDLINE,EMBASE and Cochrane database were retrieved systematically. The literature retrieval period is from no limit to December 2019,with "Buyang Huanwu Tang" and "chronic heart failure" "heart failure" as the key words for full-text retrieval of Chinese and English databases. Literatures of randomized controlled trials(RCTs)for chronic heart failure were included,and the data were extracted. Cochrane system evaluation method was used to score the quality of literature. Stata 14.0 was applied in Meta-analysis on the retrieval results. TSA0.9 was applied in test sequential analysis. Sensitivity analysis was made to explain heterogeneity,and funnel chart was used to evaluate publication bias. Result: A total of 2 037 patients were included in 21 RCT studies. The article quality risk assessment was generally unclear risk of bias. The results of meta-analysis showed that the left ventricular ejection fraction(LVEF)in the experimental group was significantly higher than that in the control group,with statistically significant differences[MD=0.901,95% CI(0.772,1.029),P<0.01],the left ventricular end diastolic diameter(LVEDd)in the experimental group was significantly lower than that in the control group,with statistically significant differences[OR=-0.650,95% CI=(-0.854,-0.446),P<0.01],BNP in the experimental group was significantly lower than that in the control group,with statistically significant differences [MD=-1.212,95% CI=(-1.359,-1.066),P<0.01],6-minute walk test(6 MWT)in the experimental group was significantly higher than that in the control group,with statistically significant differences[MD=0.797,95% CI=(0.447,1.146),P<0.01],and the effective rate in the experimental group was significantly improved,with statistically significant differences[OR=1.840,95% CI=(1.680,2.016),P<0.01]. Conclusion: Modified Buyang Huanwu Tang combined with conventional western medicine treatment of chronic heart failure is more effective than single administration of western medicine treatment,and can improve clinical efficacy,effectively improve the LVEF of patients with chronic heart failure,reduce the LVEDd reduces plasma BNP levels,prolong the 6-minute walking distance,and reduce the incidence of adverse reactions.