加载中药干预射血分数正常心力衰竭的系统评价

Traditional Chinese Medicine in the Treatment of Heart Failure with Normal Ejection Fraction:A Systematic Review

目的系统评价在西药常规治疗基础上加载中药治疗射血分数正常心力衰竭的有效性和安全性。方法从建库起至2015年10月,检索中国期刊全文数据库(CNKI)、中国科技期刊全文数据库(VIP)、万方期刊数据库(WANFANG)、中国生物医学文献数据库(CBM)、PubMed、EMBase、Cochrane Library,纳入以射血分数正常/保留的心力衰竭或舒张性心力衰竭为研究对象的随机对照临床试验,干预措施为西药常规治疗基础上加载中药(治疗组)与单纯西药常规治疗(对照组),采用Cochrane协作网开发的Revman5.3软件提供的风险评估工具评价文献质量,之后采用Revman5.3软件进行数据分析。结果入选9篇随机对照试验研究,共纳入636例射血分数正常的心力衰竭病人。常规西药加载中药治疗能提高心衰病人6 min步行试验距离(6MWD)[随机效应模型:SMD=1.24,95%CI(0.98,1.51),P<0.001],降低血浆N-端脑钠肽前体(NT-proBNP)水平[MD=-135.97,95%CI(-164.60,-107.33),P<0.001],提高心脏超声舒张早期血流峰速度(E峰)值[MD=10.36,95%CI(6.81,13.92),P<0.001],降低舒张晚期血流峰速度(A峰)值[MD=-6.28,95%CI(-10.82,-1.75),P=0.007],升高E/A值[MD=0.30,95%CI(0.23,0.38),P<0.001],在临床有效率方面,加载中药治疗优于常规西药治疗[RR=1.29,95%CI(1.15,1.44),P<0.001],在临床显效率方面也优于常规西药治疗[RR=1.61,95%CI(1.19,2.19),P=0.002]。安全性方面,未见严重不良事件及肝肾功能损害报道。结论加载中药治疗射血分数正常的心力衰竭,能提高心衰病人6MWD,降低血浆NT-proBNP水平,升高心脏超声E峰值,降低A峰值,升高E/A比值,提高临床疗效。

Objective To evaluate the efficacy and safety of traditional Chinese medicine（TCM） for heart failure with normal ejection fraction（ HFNEF） .Methods Electronic literature of CNKI, VIP, WanFang, China biological medical （CBM） literature,Pubmed, EM- Base, Cochrane Library were searched until October,2015.Randomized controlled trails （RCTs/ compared combined TCM with western medicine in patients with HFPEF or DHF were eligible for inclusion.The analysis was performed with the software of Rev- Man 5.3. Quality was assessed by using the Cochrane risk of bias tool .Results Nine RCTs,totally 636 patients with HFNEF were identified.Compared with the control group,the distances of the 6- minute walk test （6MWT） were increased EMD= 1.24, 95% Cl （0.98, 1.51）, P〈 0.001], the values of N-terminal-pro-B-type natriuretic peptide （NT- proBNP/ reduced EMD= - 135.97,95% C/（ - 164.60, - 107.33）, P 〈0.001], the E value reduced EMD= 10.36,95% Cl （6.81,13.92/, P 〈0.001}, the A value improved EMD= - 6.28, 95% Cl （ - 10.82, - 1.75）, P = 0.007], the E/A value reduced E MD = 0.30, 95% Cl （0.23, 0.38）, P 〈 0.001] in the combination group.The efficiency was improved [ RR = 1.29, 95% CI（1.15,1.44/, P 〈O.001].The clinically significant efficiency was improved ERR = 1.61,95% C/（1.19,2.19）, P = 0.002].No obvious adverse reactions and hepatic and renal impairment was reported during these trails.Conclusion Compared with the western medicine treatment, additional TCM for HFNEF was safe and effective.It could increase the distance of the 6MWT, reduce the values of NT- pro BNP, the value of E, the value E/A and the A value, improve the clinical efficacy.