基因重组乙型肝炎疫苗长期保护效果Meta分析

The meta-analysis of long term vaccine protective efficacy of recombinant hepatitis B vaccine

目的评价接种3剂次基因重组乙型肝炎疫苗（recombinant hepatitis B vaccine,HBV-R）5年以上的长期保护效果。方法电子检索《中国生物医学文献数据库》（China Biology Medicine disc,CBMd）、《中国期刊全文数据库》（China National Knowledge Infrastructure,CNKI）、《万方全文数据库》（Wanfang Database,WF）、《美国国家医学图书馆数据库》（National Center for Biotechnology Information,NCBI）、《考克兰（Cochrane）协作网图书馆》等数据库,将有关接种HBV-R流行病学保护效果的研究纳入分析。使用Rev Man 5.1软件进行分析。结果共纳入13篇文献和4 882观察对象,有4篇为随机对照试验（random control trial,RCT）,有9篇为前瞻性队列研究（prospective cohort study,PCS）;接种HBV-R后5~20年的乙肝病毒突破感染（breakthrough infection,BI）和（chronic carriage,CC）的累计发生率（accumulative incidence,AI）分别为0.01[95%可信区间（confidence interval,CI）：0.00-0.01],0.00（95%CI：0.00-0.00）。结论全程接种3剂次HBV-R后,可以有效保护免疫功能正常人群且保护效果至少持续20年。

To evaluate long term（5 years follow-up or more） vaccine protective efficacy of recombinant hepatitis B vaccine（HBV-R）, we have searched ＂China Biology Medicine disc（CBMd）＂, ＂China National Knowledge Infrastructure（CNKI）＂, ＂Wanfang（WF） Database＂, ＂National Center for Biotechnology Information（NCBI）＂, and ＂Cochrane Library＂ for random control trial（RCT） and prospective cohort study（PCS） of long term（at least 5 years） protective efficacy for HBV-R, and Rev Man 5.1 software was adopted to analyze the pooled accumulative incidences（AI） of breakthrough infection（BI） and chronic carriage（CC） by different following period,study design and various endemic regions. A total of 13 studies were included, of which 4 studies were RCT and 9studies were PCS. The AI of BI and CC were 0.01（95% CI（confidence interval）： 0.00-0.01） and 0.00（95% CI：0.00-0.00）, respectively. At last, we concluded that the protection provided by three doses of HBV-R persists for at least two decades in the great majority of immune competent individuals.