参芪扶正注射液联合常规用药治疗心力衰竭的系统评价

Abstract

目的:系统评价参芪扶正注射液联合常规用药治疗心力衰竭的有效性和安全性.方法:计算机检索Cochrane图书馆(2013年第2期),Medline(1950～2013.2),EMbase(1980～2013.2),中国生物医学文献数据库(CBM,1978～ 2013.2),中国科技期刊全文数据库(VIP,1989 ～ 2013.2),中国期刊全文数据库(CNKI,1995～2013.2)万方数据库(1990～2013.2),纳入有关参芪扶正注射液治疗心力衰竭的随机对照试验,根据Cochrane手册“对随机对照试验偏倚风险的评估工具(Version 5.1.0)”对纳入的研究进行方法学质量评价,并使用RevMan 5.2.4软件进行统计分析.结果:共纳入21个随机对照试验,共1 829名受试者,均为低质量研究.Meta分析结果显示:参芪扶正注射液联合常规用药在治疗心力衰竭的患者的临床疗效[OR=3.91,95％Cl(2.63,5.83)],提高左室射血分数(LVEF)[MD =0.08,95％Cl(0.05,0.12)],每搏输出量(SV)[MD=9.42,95％ Cl(6.61,12.22)],心脏指数(CI)[MD=0.60,95％ Cl(0.46,0.73)],心输出量(CO) [MD =0.98,95％ Cl(0.61,1.36)],降低脑力肽浓度(BNP)[MD=-139.05,95％Cl(-211.08,-67.02)]方面优于常规治疗.治疗期间参芪扶正注射液联合常规用药组未见明显不良反应/事件.结论:现有临床证据表明西医常规用药的基础上加用参芪扶正注射液可以提高治疗心力衰竭的疗效,但由于本系统评价纳入研究质量较低,增加了该次系统评价结论产生偏倚的风险,因此参芪扶正注射液治疗心力衰竭疗效和安全性需要更多高质量临床试验加以证实.

To assess the efficacy and safety of parenterally administered Shenqi Fuzheng for heart failure.We searched for all clinical studies, up to February 2013, of parenterally administered Shenqi Fuzheng in the Cochrane library, Medline, EMbase, CBM, CNKI, VIP and Wanfang. Quality assessment and information extraction was completed and screened by two independent reviewers. The quality of the included studies was evaluated according to the Cochrane collaboration's tool for assessing risk of bias and allocation concealment. Revman 5. 2. 4 software was used for data analysis.A total of 21 randomized controlled trials were included in this systematic review, all of them were of low quality. Meta-analysis showed that the group receiving parenterally administered Shenqi Fuzheng in addition to conventional treatment had better therapeutic effectiveness rates than the conventional treatment group [OR = 3.91, 95% Cl (2.63, 5.83)], with enhanced LVEF [MD = 0.08, 95% Cl (0.05, 0.12)], SV [MD = 9.42, 95% Cl (6.61, 12.22)], CI [MD = 0.60, 95% Cl (0.46,0.73)], CO [MD = 0.98, 95% Cl (0.61, 1.36)], reduced BNP [MD = -139.05, 95% Cl (-211.08, - 67.02)]. The ADR/ADE information of parenterally administered Shenqi Fuzheng in all studies showed that the symptoms of ADR/ADE were mild.Conclusions from this review may have a high risk of bias due to the low quality of thestudies. Hence, reliable conclusions cannot be drawn about the efficacy of parenterally administered Shenqi Fuzheng in the treatment of heart failure. More trials of high quality are required.