西药联合生脉注射液治疗慢性心力衰竭随机对照试验的系统评价

Treatment of chronic heart failure with Western drugs combining Shengmai Injection: a systematic review on randomized controlled trials

目的系统评价西药联合生脉注射液治疗慢性心力衰竭的有效性和安全性。方法计算机检索中国期刊全文数据库(CNKI,1979.01~2013.12)、中文科技期刊全文数据库(VIP,1989.01~2013.12)、万方期刊数据库(Wan Fang,1978.01~2013.12),Pub Med(1978~2013.12)、Cochrane Library(2013年第4期)。手工检索相关杂志,搜集西药联合生脉注射液治疗慢性心力衰竭的随机对照试验,按照Cochrane Handbook方法评价纳入研究质量和提取有效数据,采用Rev Man5.2.0软件进行系统评价。结果共纳入12个临床随机对照试验,总计939例患者,其研究质量均为C级。Meta分析显示:西药联合生脉注射液可显著改善心衰患者中医临床疗效[RR=1.23,95%CI(1.14~1.33),P<0.01],改善慢性心衰患者的心功能分级[RR=1.36,95%CI(1.20~1.55),P<0.01]以及生存质量量表积分[WMD=-6.49,95%CI(-12.31^-0.67),P=0.03],增加左心室射血分数[WMD=9.22,95%CI(5.88~12.56),P<0.01]和6分钟步行试验距离(P<0.05),同时降低心衰患者的血浆脑钠肽(BNP)水平(P<0.05)。有1项研究显示生脉注射液可能会降低体循环外周阻力(SVR)及降低血管性血友病因子(v WF)、P-选择素、D-二聚体水平,另外有2项研究显示生脉注射液可能会降低慢性心衰患者N-末端脑钠肽(NT-pro BNP)水平和改善心率变异性(HRV)等。结论西药联合生脉注射液较单纯西药常规治疗心力衰竭可进一步提高临床疗效。

Objective To review systematically the effectiveness and safety of Western drugs combining Shengmai Injection on chronic heart failure （CHF）. Methods The databases of CNKI （from 1979-1 to 2013-12）, VIP （from 1989-1 to 2013-12）, WanFang Database （from 1978-1 to 2013-12） and Cochrane Library （4th issue of 2013） were retrieved with computer and related journals were retrieved manually for collecting the randomized controlled trials （RCT） about treatment of CHF with Western drugs combining Shengmai Injection. The quality of included RCT was assessed and effective data was extracted according to Cochrane Handbook, and all data was reviewed by using RevMan5.2.0 software. Results There were totally 12 RCT included involving 939 cases, and the quality of RCT all reached level C. The results of Meta-analysis showed that clinical effect of Chinese medicine [RR=1.23, 95%CI （1.141.33）, P〈0.01], heart function [RR=1.36, 95%CI （1.201.55）, P〈0.01] and integral of life quality scale [WMD=-6.49, 95%CI （-12.31-0.67）, P=0.03] were improved, LVEF [WMD=9.22, 95%CI （5.8812.56）, P〈0.01] and 6MWT （P〈0.05） increased, and BNP level decreased （P〈0.05, P〈0.01） in CHF patients. There was 1 RCT showed that Shengmai Injection might reduce the levels of SVR, vWF, P-selectin and D-dimer, and 2 RCT showed that Shengmai Injection might reduce NT-proBNP level and HRV. Conclusion Western drugs combining Shengmai Injection can further improve clinical efficacy in treatment of CHF.