妈咪爱佐治新生儿高胆红素血症疗效的Meta分析

A Meta Analysis of Medilac-Vita' Adjunctively Therapeutic Effect for Neonatal Hyperbilirubinemia

目的:评价妈咪爱对新生儿高胆红素血症(NHBE)的佐治作用,为进一步临床实践提供证据。方法:检索Cochrane Library(2012年第6期)、PubMed、Medline、Embase、中国学术期刊网络出版总库、万方数据库、维普数据库等,收集有关妈咪爱佐治NHBE的RCT文献,检索文献起止时间均为建库至2012年10月。由2名作者进行资料提取和文献质量评价。应用RevMan5.2软件进行Meta分析,根据异质性结果选择相应的效应模型分析;无法进行Meta分析时采用描述性分析。结果:13个RCT进入Meta分析,全部文献均描述了具体随机化方法,但没有采用充分的分配隐藏和盲法;13篇均为中度偏倚风险。Meta分析结果显示,诊断NHBE共计2061例,妈咪爱佐治组为53.13%,对照组为46.87%,日均胆红素下降值比较MD=15.52,95%CI(11.99,19.05),P<0.00001,差异有统计学意义;胆红素下降至正常值需要的治疗时间比较MD=-1.83,95%CI(-2.10,-1.55),P<0.00001,差异有统计学意义。结论:Meta分析结果支持妈咪爱佐治NHBE,建议开展设计更加科学,执行更加严谨的多中心大样本临床试验。

Objective：To evaluate adjunctive ly therapeutic effect of Medilac-Vita for Neonatal Hyperbil-irubinemia （NHBE,and to provide some clinically practical evidence.Methods：Cochrane Library（issue 6, 2012）,PubMed,Medline,Embase,China academic journal network publishing data library,Wangfang data library,and Weipu data library were searched,and Randomized Controlled Trials（RTC）of Medilac-Vita’ adjunctively therapeutic effect for Neonatal Hyperbilirubinemia were involved.The time of bibliographic re-trieval was from when the databases existed to October 2012.2 authors collected the data and evaluated qual-ity of data.Software of RevMan5 .2 was applied.Different Effect model analysis was chosen according to het-erogeneity results,while descriptive analysis failed to be done by meta analysis was adopted.Results：1 3 RCT were invlved,all of which descriped detailed randomization method,but there were no adopted sufficient allo-cation concealment and blinding,and showed medium risk of bias.It showed that 2061 patients were diag-nosed as NHBE,with 53.13% treated by Medilac-Vita,and 46.87% as control group.Comparison MD of av-erage daily bilirubin decreased value was 15.52,with 95%CI（11.99,19.05）and statistically significant differ-ence （P＆lt;0.00001）.Comparison MD of therapeutic time how long bilirubin drops to normal was1.83,with 95%CI （-2.10,-1.55）,and statistically significant difference （P＆lt;0.00001）.Conclusion：Our results sup-port Medilac-Vita’adjunctively therapeutic effect for Neonatal Hyperbilirubinemia.To further confirm, more scientific designs and rigorous multicenter,large sample clinical trials should be carried out.