参麦注射液治疗小儿病毒性心肌炎的系统评价

目的系统评价参麦注射液治疗小儿病毒性心肌炎的疗效及安全性。方法计算机检索CBM（1981～2009.11）、CNKI（1980～2009.11）、VIP（1989～2009.11）、Cochrane图书馆（2010年第1期）、PubMed（1966～2009）、EMbase（1966～2009）等数据库,全面搜集有关参麦注射液治疗小儿病毒性心肌炎的随机对照试验（RCT）和半随机对照试验,质量评价参照Cochrane系统评价员手册5.0.1标准,数据分析采用RevMan5.0软件。结果共纳入15个RCT,但研究质量均不高。纳入文献均未提及隐蔽分组及盲法。Meta分析结果显示：①常规治疗＋参麦注射液组的总有效率[RR=1.16,95%CI（1.07,1.25）]、心电图改善率[RR=1.55,95%CI（1.25,1.93）]及在降低CK和CK-MB方面均优于单纯常规治疗,但在降低AST方面两组差异无统计学意义。②常规治疗＋参麦注射液组的总有效率[RR=1.12,95%CI（1.01,1.25）]、心电图改善率[RR=1.35,95%CI（1.07,1.70）],及在降低CK、AST方面均优于西药＋常规组,但在降低CK-MB方面,两组差异无统计学意义。③常规治疗下参麦注射液＋西药组的总有效率[RR=1.26,95%CI（1.12,1.42）]及在降低CB-MB和LDH-1优于常规治疗＋西药组。有4个研究报告了参麦注射液治疗后的不良反应,主要为轻微皮疹以及脸红、胸闷,无严重不良反应事件报道。结论现有临床证据表明,参麦注射液治疗小儿病毒性心肌炎有一定效果,可提高总有效率,降低心肌酶,提高心电图改善率。但由于本研究纳入的原始文献质量不高,影响研究结果的论证强度。有待于开展更多高质量的研究以进一步证实其疗效和安全性。

Shenmai Injection for Children with Viral Myocarditis: A Systematic Review

Objective To assess the efficacy and safety of Shenmai injection for children with viral myocarditis.Methods All randomized and quasi-randomized controlled trials（RCTs and quasi-RCTs） of Shenmai injection for children with viral myocarditis were searched from CBM（1981 to November 2009）,CNKI（1980 to November 2009） and VIP（1989 to November 2009）,The Cochrane Library（Issue 1,2010）,PubMed（1966 to 2009）,EMbase（1966 to 2009）.Cochrane systematic reviews Handbook 5.0.1 was taken as a reference to quality evaluation of the included studies,and the Cochrane Collaboration＇s RevMan 5.0 software was used for data analyses.Results A total of 15 RCTs were included.The quality of the included trials was low.The result of meta-analyses showed that：（1） The effective rate（RR 1.16,95%CI 1.07 to 1.25） and the ECG improvement rate（RR 1.55,95%CI 1.25 to 1.93） in Shenmai injection group were better than those in the control group.CK and CK-MB in Shenmai injection were lower than those in the control group,but the AST level was similar in the two groups.（2） The effective rate（RR 1.12,95%CI 1.01 to 1.25） and the ECG improvement rate（RR 1.35,95%CI 1.07 to 1.70） in Shenmai injection group were better than those in the western medicine plus routine therapy（RT） group.CK,AST and LDH in Shenmai injection group were lower than those in the western medicine plus RT group,but CK-MB was similar in the two groups.（3） The effective rate（RR 1.26,95%CI 1.12 to 1.42） in Shenmai injection plus RT and western medicine group was better than that in RT and western medicine group.CK and LDH-1 in Shenmai injection plus RT and western medicine group were lower than those in RT and western medicine group.Adverse reactions of Shenmai injection in 4 studies included mild rash,rubicundity and chest distress.No severe adverse reactions were reported.Conclusion The evidence currently available shows that Shenmai injection may have some effect on children with viral myocarditis,including improving the effective rate,reducing myocardial enzymes and improving theECG improvement rate.However,because of the low methodological quality of the included trials,this conclusion needs to be interpreted cautionsly,and more well-designed,high-quality RCTs need to be performed.