口服轮状病毒减毒活疫苗保护效果研究Meta分析

The Meta-Analysis of Vaccine Protective Efficacy of Oral Rotavirus Attenuated Live Vaccine

目的评价口服轮状病毒减毒活疫苗(Oral Rotavirus Attenuated Live Vaccine,ORV)的流行病学保护效果。方法电子检索《中国生物医学文献数据库》、《中国期刊全文数据库》、《万方全文数据库》、National Center forBiotechnology Information(NCBI)(《美国国家医学图书馆数据库》)、《Cochrane(考柯兰)协作网图书馆》等数据库,将有关接种ORV流行病学保护效果的研究纳入分析。使用RevMan4.2.10软件进行统计分析。结果共纳入14篇文献,有6项为随机对照试验研究,8项为队列研究。单价兰州羊(Monovalent Lanzhou Lamb)ORV(ORV-L)对轮状病毒胃肠炎(Rotavirus Gastroenteritis,RVGE)的保护率为76%[95%可信区间(Confidence Interval,CI):67%～83%];单价人(Monovalent Human)ORV(ORV-H)和五价人-牛重配(Pentavalent Human-BovineReassortant)ORV(ORV-HB)对RVGE、严重(Severe)RVGE(SRVGE)和住院率(Hospitalized rate)的合并保护率分别为61%(95%CI:28%～79%)、71%(95%CI:44%～85%)和88%(95%CI:67%～96%)。7篇文献报道了ORV的安全性,无严重不良反应和死亡报告。结论接种不同种类的ORV可以不同程度地降低RVGE的发病,减少SRVGE和降低AR,具有良好的保护效果。

Objective To evaluate vaccine protective efficacy（VE） of oral rotavirus attenuated live vaccine（ORV） used in China. Methods Searching ＂China Biology Medicine disc,CBMd＂, ＂China National Knowledge Infrastructure, CNKI＂, ＂Wanfang Database, WF＂ database, ＂National Center for Biotechnology Information, NCBI＂,＂ Cochrane Library,CL＂, the studies of VE for ORV were included, and meta analysis were made by RevMan4.2.10 software. Results A total of 14 studies were included, 6 studies were random clinic trial （RCT）, 8 studies were cohort studies. The VE of monovalent Lanzhou lamb rotavirus vaccine （ORV-L） against rotavirus gastroenteritis （RVGE） was 76 % [95 % （confidence interval, CI）：67%-83% ]. The combined VE of monovalent attenuated human rotavirus vaccine （ORV-H） and pentavalent human-bovine reassortant rotavirus vaccine （ORV-HB） against RVGE, Severe rotavirus gastroenteritis （SRVGE）, hospitalized rate were 61% （95 % CI：28 %-79 % ） ,71% （95 % CI：44%-85%）, 88%（95%CI：67%-96%） respectively. There were no severe adverse event and death reported. Conclusions Inoculating different type of ORV can gain different level of protection against rotavirus gastroenteritis, and also can reduce the morbidity of severe or hospitalized cases.