ACYW135群脑膜炎球菌多糖结合破伤风毒素疫苗免疫学效果的Meta分析

The Meta-analysis of immunogenicity of meningococcal ACYW135 polysaccharide tetanus toxoid conjugate vaccine

目的评价ACYW135群脑膜炎球菌多糖结合破伤风毒素疫苗（MPCV-ACYW135-TT）的免疫学效果。方法检索National Center for Biotechnology Information（NCBI）,Cochrane协作网图书馆、中国生物医学文献数据库、中国期刊全文数据库和万方全文数据库，将有关评价MPCV-ACYW135免疫学效果的随机对照试验（RCT）的研究纳入分析。以接种疫苗1个月后产生的血清杀菌活性（SBA）抗体阳转率（PRR）和几何平均滴度（GMT）作为结局指标，合并不同研究中试验组与对照组间的PRR和GMT的率差（RD）或标准化均数差（SMD）。使用RevMan5．1软件进行Meta分析。结果共纳入13篇文献：有9篇比较了MPCV-ACYWl35-TT和ACYW135群脑膜炎球菌多糖疫苗（MPV-ACYWl35）之间免疫学效果差异，4篇比较了MPCV-ACYWl35-TT和C群脑膜炎球菌多糖结合白喉毒素变异体197疫苗（MPCV-C-CMR197）之间免疫学效果差异。相比于MPV-A-CYWl35；受试者在接种MPCV-ACYW135-TT后产生的针对A、C、Y和W135这4个血清型抗体PRR的RD在0．03～0．15之间；产生的针对A、Y和W135这3个血清型抗体GMT的SMD在0．33～1．22之间。1～2岁组幼儿在接种MPCV-ACYW135-TT后产生的针对C群抗体GMT与接种MPCV-C-CMR197差异无统计学意义（P〉0．05）。结论MPCV-ACYW135-TT与其他已上市应用的脑膜炎球菌疫苗有相似的免疫效果。

Objective To evaluate the immunogenicity of meningococcal ACYW135 polysaccharide tetanus toxoid conjugate vaccine （MPCV-ACYW135-TT）. Methods Searching random control trials （RCT） in National Center for Bioteehnology Information（NCBI）, Cochrane Library（CL）, China Biology Medicine disc （CBMd）, China National Knowledge Infrastructure （CNKI） and Wanfang Database for comparing immunogenieity of MPCV-ACYW135-TT. The positive response rate （PRR） and geometric mean titer （GMT） of serum bactericidal activity （SBA） antibody with an interval of one month after vaccination were used as our endpoints. We pooled risk difference （RD） or standardized mean difference （SMD） of PRR and GMT from both treatment and control groups in different studies. Meta-analysis was made by RevMan5.1 software. Results Thirteen studies were included, of which 9 studies compared MPCV-ACYW135-TT with meningococcal ACYW135 polysaceharide yaccine （MPV-ACYW135） and 4 studies compared the immunogenicity of MPCV-ACYW135-TT with meningoeoccal C polysaccharide cross reactive material 197 conjugate vaccine （MPCV-C- CMRI97）. Compared with MPV-ACYW135, the RDs of PRR of antibodies against four serogroups A, C, Y and W135 after immunization with MPV-ACYW135-TT were from 0.03 to 1.15; the SMDs of GMT of antibodies against three serogroups A, Y and W135 were from 0.33 to 1.22. The SMDs of GMT of the antibody against serogroup C showed no significant difference between children aged 1-2 years old vaccinated with MPV-ACYW135-TTT and MPCV-C-CMR197 （P〉0.05）. Conclusions It suggests that the MPCV-ACYW135-TT vaccine is as immunogenic as the other commercial available meningococcal vaccines.