不同剂量乙肝基因工程疫苗免疫效果Meta分析

Meta-analysis on the immunogenicity of different dosages of engineering hepatitis B vaccine

目的探讨3针20μg与3针10μg乙型肝炎（乙肝）基因工程疫苗抗-HBs阳转率的差异。方法在中国学术期刊全文数据库（CNKI）、万方数据库、国家科技图书文献中心杭州镜像站及维普资讯中文科技期刊数据库中以“乙肝OR乙型肝炎”及“疫苗”为关键词检索2000年1月～2013年5月国内公开发表的有关3针20μg与3针10μg乙肝基因工程疫苗全程接种后1个月及1年抗HBs阳转率的文献，采用Stata10．0软件进行Meta分析。结果共纳入18篇文献，Meta分析结果显示，全程免疫后1个月，3针20μg重组酵母乙肝疫苗抗-HBs阳转率显著高于3针10μg重组酵母乙肝疫苗（Z=2．78，P=0．005），合并RR为1．045（95％C1：1．013～1．079）；3针20μgCHO细胞乙肝疫苗抗-HBs阳转率显著高于3针10μgCHO细胞乙肝疫苗（Z=5．86，P〈0．01），合并RR为1．065（95％CI：1．043～1．088）。全程免疫后1年，3针20μg与3针10μg重组酵母乙肝疫苗抗-HBs阳转率差异有统计学意义（Z=2．38，P=0．017），合并RR为1．103（95％CI：1．018-1．196）。敏感性分析结果显示结果具有较好的稳定性。未发现纳入文献存在发表偏倚（P〉0．05）。结论3针20μg乙肝基因工程疫苗免疫效果优于3针10弘g乙肝疫苗。

Objective To discuss the difference of positive seroconversion rate of anti HBs between 3 shots of 20 vg and 3 shots of 10 μg engineering hepatitis B vaccine. Methods Using ＂hepatitis B＂ and ＂vaccine＂ as key words to search literatures closely related to the study purpose and published in China National Knowledge Infrastructure （CNKI）, Wanfang Database, The National Science and Technology Library of Hangzhou mir- ror and VIP China Scientific Journal Database. Statal0.0 software was used for Meta-analysis. Results In total, 18 papers were retrieved. Meta-analysis showed that 3 shots 20 μg recombinant yeast hepatitis B vaccine （Z=2.78, P=0.005） and Chinese hamster ovary （CHO） hepatitis B vaccine （Z：5.86, P〈0. 01） trig- gered significant higher rate of antibody positive seroconversion compared to 3 shots of 10μg one month after the full vaccination, with the pooledRR of 1.045 （95%CI： 1. 013-1. 079） and 1. 065 （95%CI： 1.043- 1. 088）. Also, the difference of antibody conversion rate was significant between this two dosages one year after the full vaccination for recombinant yeast hepatitis B （Z= 2.38, P 0. 017）, with the pooled RR of 1. 103 （95 % CI ： 1. 018- 1. 196）. Sensitivity analyses revealed that the result was consistent and no publication bias was found （P〉0.05）. Conclusions Three shots of 20μg engineering hepatitis B vaccine bears better immu- nogenicity than 3 shots of 10 μg.