黄芪注射液佐治新生儿缺氧缺血性脑病疗效的系统评价

Huangqi injection for hypoxic-ischemic encephalopathy:a systematic evaluation

目的系统评价黄芪注射液治疗新生儿缺氧缺血性脑病(HIE)的临床疗效及安全性。方法计算机全面检索Cochrane Library、PubMed、Embase、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普中文科技期刊数据库(VIP)和万方数字化期刊全文数据库等(各数据库检索时间均从建库起到2016年11月),同时检索相关文献的参考文献,并辅以手工检索相关杂志和会议论文等。收集有关黄芪注射液治疗新生儿HIE的随机或半随机对照试验,依据Coehrane Handbook推荐的文献质量评价办法对符合纳入标准的文献进行质量评价,应用RevMan 5.3软件进行统计学处理。结果最终纳入6篇文献,总计390例患儿,包括黄芪注射液治疗组220例,常规治疗对照组170例。Meta分析结果显示,在常规治疗基础上加用黄芪注射液可提高HIE患儿的新生儿行为神经评分[MD=3.61;95%CI(1.86,5.36)]、缩短临床症状的平均恢复时间[MD=-1.40;95%CI(-1.66,-1.15)],且原始反射、肌张力及意识恢复情况均优于对照组,差异均有统计学意义(P<0.05)。所纳入研究均未观察到不良反应的发生。结论目前有限的证据表明应用黄芪注射液治疗新生儿HIE具有一定的疗效,但由于所纳入研究质量不高,且缺乏长期疗效评价的证据,尚需更多设计良好、规模较大的随机对照试验研究进一步加以验证。

Objective To systematically evaluate the efficacy and safety of Huangqi injection for hypoxic ischemic encephalopathy(HIE).Methods According to the inclusion criteria,random or semi random controlled trials related to Huangqi injection in the treatment of HIE were searched and selected from PubMed,Embase,Cochrane Library,CBM,CNKI and VIP,etc.(from their inception to November 2016),and relevant literature references were retrieved,supplemented by hand searching of relevant journals and conference papers.Assess the methodological quality of the included trials according to Cochrane Handbook for systematic reviews of interventions.Meta analysis was performed using the Cochrane Collaboration's RevMan 5.3.Results Six randomized controlled trials were included.In the 6 trials,there were 390 cases of HIE,including 220 cases treated by Huangqi injection and 170 cases receiving conventional treatment in the control group.Meta analysis results showed that conventional treatment combined with Huangqi injection could improve the NBNA[MD=3.61,95%CI(1.86,5.36)],shorten the average healing time[MD=-1.40,95%CI(-1.66,-1.15)],and the recovery of clinical symptoms,such as primitive reflex,muscle tension and consciousness was better than the control group,the difference being of statistical significance(P<0.05).No side effects were reported.Conclusion Limited evidence indicates that application of Huangqi injection in the treatment of neonatal HIE has a certain curative effect,but because of the low statistical quality of the included trials and the lack of evidence of long term effect,more well designed and large scale randomized controlled trials are needed to verify it.