西医常规加黄芪注射液治疗小儿病毒性心肌炎临床疗效及安全性的系统评价

Astragalus membranaceus Injection(AMI)in children's viral myocarditis(VMC):a systematic review

目的评价西医常规加黄芪注射液(AMI)治疗小儿病毒性心肌炎(VMC)的临床疗效和安全性。方法制定原始文献的纳入标准、排除标准及检索策略,检索Cochrane图书馆临床对照试验数据库、Pubmed数据库、中国期刊全文数据库、维普中文科技期刊数据库,获得AMI治疗小儿VMC的相关文献;使用Cochrane协作网推荐的方法进行文献质量评价;采用RevMan4.2.10软件对满足纳入标准的有关AMI治疗小儿VMC的随机对照试验文献进行Meta分析;以临床总有效率、心肌酶、心电图、心功能和不良反应发生率作为观察指标,进行定性及定量综合评估。结果共检索到291篇文献,符合纳入标准的22项研究(934/847)进入Meta分析。Jadad评分所有研究得分均低于3分,属低质量文献。Meta分析结果显示:21项研究(894/807)临床总有效率RR及95%CI为4.53[3.33,6.17]。7项研究(342/322)肌酸激酶同工酶(CK-MB)的WMD及95%CI为-10.19[-14.02,-6.36]。7项研究(302/264)心电图改善率RR及95%CI为4.47[2.73,7.31]。1项研究(44/39)射血分数的WMD及95%CI为2.30[-3.22,7.82]。系统评价结果显示,AMI与对照组比较,临床总有效率、心电图改善率、心肌酶CK-MB差异有统计学意义(P<0.00001)。结论 AMI可明显提高患儿临床总有效率、心电图改善率,降低血清CK-MB,且临床安全性较好。但由于纳入研究文献质量普遍较低,影响研究结果的可靠性,要进一步验证其疗效及安全性,尚需进行设计合理、执行严格、多中心大样本且随访时间足够的随机对照试验。

Objective To evaluate the effect and safety of Astragalus membranaceus Injection（AMI）combined with convetional western medicine in treating children＇s viral myocarditis（VMC）.Methods We formulated the inclusion criteria,exclusion criteria and retrieval strategy on the basis of original literatures,searched Cochrane central Register of Controlled Trials,PUBMED,CNKI,VIP.Randomized controlled trials（RCTs）of routin treatment（RT）with AMI compared with RT only in treating children＇s VMC and eligible studies were included;the methodological quality of inclusive trials was assessed by Jadad scale of Cochrane Collaboration recommended.Meta-analysis was used to analyse the data by statistical software RevMan4.2.10.We adopted clinical effective rate,EKG,myocardial enzymes,cardiac function and adverse reaction rate as observation indexs,made qualitative and quantitative analysis.Results We found 291 literatures totally.Among these literatures,22 RCTs（934/847）were selected.All RCTs were low methodological quality according to Jadad score index.Meta-analysis indicated that RR and 95% CI of 21 RCTs＇s（894/807）effective rate was 4.53[3.33,6.17].WMD and 95% CI of 7 RCTs＇s（342/322）improving CK-MB and 1 RCT＇s（44/39）improving EF were-10.19[-14.02,-6.36] and 2.30[-3.22,7.82] respectively.RR and 95% CI of7 RCTs＇s（302/264）EKG improvement rate was 4.62[2.72,7.84].This systematic review showed that AMI was effective and safe for children＇s VMC.In view of effective rate,EKG improvement rate and improving CK-MB,there were great difference between two groups（P 〈0.00001）.Conclusions AMI is effective and safe for children＇s VMC;it can improve clinical effect rate and EKG improvement rate,decrease CK-MB in blood for.However,the evidence is not strong because of low methodological quality of these literatures.To further evaluate the effect and safety of AMI for children＇s VMC more rationally designed and strictly executed RCTs with large samples need to be made.