黄芪治疗新生儿缺血缺氧性脑病有效性和安全性的Meta分析

Efficacy and safety of Radix Astragali in the treatment of hypoxic ischemic encephalopathy in newborns:Meta-analysis

目的系统评价黄芪治疗新生儿缺血缺氧性脑病(HIE)的疗效和安全性。方法计算机检索Cochrane图书馆、Pub Med、Cochrane对照试验数据库、EMBASE中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、中国科技期刊全文数据库(VIP)、万方数据库,全面收集黄芪治疗HIE的随机对照试验(RCT),根据Cochrane协作网系统评价的方法进行评价。结果共纳入13项研究(1031名患者),其中11项研究为空白对照,2项为阳性对照。无随访12个月后病死率或致残率的研究报道,仅1项研究比较了黄芪组和空白对照组在治疗期末降低HIE病死率的疗效,Meta分析结果显示,两组差异无统计学意义[RR=0.33,95%CI(0.04,3.07),P=0.33]。7项研究(n=597)评价了黄芪组和空白对照组治疗HIE的有效率,Meta分析结果显示,两组差异有统计学意义[RR=1.22,95%CI(1.07,1.39),I2=48%,P=0.33]。3项研究(n=163)比较了黄芪组和空白对照组在改善第7天(NBNA)分值的疗效,Meta分析结果显示,两组差异有统计学意义[MD=5.37,95%CI(1.46,9.27),I2=89%,P=0.007]。2项研究(n=111)比较了黄芪组和空白对照组在改善第10天NBNA分值的疗效,Meta分析结果显示,两组差异有统计学意义[MD=2.03,95%CI(1.37,2.69),I2=0,P<0.000 01]。未见严重不良反应报道。结论基于当前的研究证据,因研究质量及研究样本的局限性,尚不足以推荐黄芪在治疗新生儿HIE中的应用,其长期疗效和安全性尚需远期高质量的研究证实。

Objective To evaluate the efficacy and safety of Radix Astragali（Huang Qi）for newborns with hypoxic ischemic encephalopathy（HIE）. Methods We searched the Cochrane library,Pub Med,Cochrane,EMBASE,CBM,CNKI,VIP and Wanfang database,randomized controlled trial（RCT）evaluating the efficacy and safety of Huang Qi for newborns with HIE would be included and the methodological quality of RCT was evaluated according to the Cochrane Handbook for Systematic Reviews of Interventions version 5.1.0. Results Thirteen studies were included（1031 patients）,11 RCT used open control as control,2 RCT used positive control. There was no trial reported the death or disability at the end of 12 months follow-up period. Meta-analysis of one study showed Huang Qi group could not significantly reduced mortality rate of HIE compared with open control group[RR=0.33,95%CI（0.04,3.07）]. Meta analysis of 7 studies（n=597）showed that the efficacy rate of huang Qi group was significantly higher than that of open control group in treatment of HIE[RR=1.22,95%CI（1.07,1.39）,I2=48%]. Meta-analysis of 3 trials（n=163）showed that there was significant difference in the improvement of NANA scale on the seventh day[MD=5.37,95%CI（1.46,9.27）,I2=89%]between Huang Qi group and open control group. Meta-analysis of 2 trials（n=111）showed that there was significant difference in the improvement of NANA scale on the tenth day[MD=2.03,95%CI（1.37,2.69）,I2=0]between Huang Qi group and open control group.No fatal side effects were reported. Conclusion Based on the current evidence,due to the limitation of quality of included studies and sample size,the routine use of Huang Qi for treatment of HIE in newborns is not recommended. The long-term efficacy and safety studies are required to confirm it.