3岁以上人群接种国产四价流感病毒灭活疫苗安全性和免疫原性的Meta分析  

Meta-analysis on safety and immunogenicity of domestic inactivated quadrivalent influenza vaccine in people over three years old

作　　者：邓鹏 钱小爱 李琼[1] 沈恒 王兆[1] 刘岩 占发先[1] 杨北方[1] DENG Peng;QIAN Xiaoai;LI Qiong;SHEN Heng;WANG Zhao;LIU Yan;ZHAN Faxian;YANG Beifang(Hubei Provincial Center for Disease Control and Prevention,Wuhan 430079,Hubei Province,China)

机构地区：[1]湖北省疾病预防控制中心,湖北武汉430079

出　　处：《中国生物制品学杂志》2024年第6期703-709,717,共8页Chinese Journal of Biologicals

基　　金：国家重大新药创制科技重大专项(2018ZX09734004)。

摘　　要：目的Meta分析评价3岁以上人群接种国产四价流感病毒灭活疫苗(quadrivalent influenza vaccine,QIV)的安全性及免疫原性,以期为我国制定QIV免疫策略提供循证依据。方法检索PubMed、EMBASE、Cochrane Library、中国生物医学文献光盘数据库(China Biology Medicine disc,CBMd)、万方数据库、中国期刊全文数据库(China National Knowledge Infrastructure,CNKI),将比较3岁以上人群接种国产QIV和三价流感病毒灭活疫苗(trivalent influenza vaccine,TIV)安全性和免疫原性随机对照试验的文献纳入分析,应用Stata11.0软件对纳入文献数据进行Meta分析。结果共纳入4篇文献。QIV与TIV比较,局部及全身反应发生率的合并效应值风险比(risk ratio,RR)分别为1.10(95%CI:0.88~1.38,I^(2)=0,P=0.809)和0.97(95%CI:0.87~1.09,I^(2)=0,P=0.485)。QIV与TIV比较,接种后对于含有相同疫苗毒株的抗体阳转率(seroconversion rate,SCR)和抗体保护率(seroprotection rate,SPR)的RR(分别为0.98~1.06及0.98~1.02)差异均无统计学意义(I^(2)分别为28.8%~89.9%和0~80.2%,P均>0.05);而对于TIV中不包含的乙型疫苗株差异均有统计学意义,其中针对B/Victoria的SCR及SPR的RR分别为2.88(95%CI:1.75~4.74,I^(2)=98.3%,P<0.001)和1.64(95%CI:1.16~2.33,I^(2)=99.3%,P<0.001),针对B/Yamagata的SCR及SPR的RR分别为1.89(95%CI:1.57~2.27,I^(2)=94.4%,P<0.001)和1.15(95%CI:1.04~1.28,I^(2)=98.4%,P<0.001)。结论3岁以上人群接种国产QIV不仅具有与TIV相似的安全性和免疫原性,还可对TIV未包含的乙型流感疫苗株产生较好免疫效果。Objective To evaluate the safety and immunogenicity of domestic inactivated quadrivalent influenza vaccine(QIV)in people over three years old by using Meta-analysis,in order to provide evidence-based basis for formulating QIV immunization strategy in China.Methods Literature was retrieved by PubMed,EMBASE,Cochrane Library,China Biology Medicine disc(CBMd),Wanfang Database and China National Knowledge Infrastructure(CNKI).All the studies were the random control trials for comparing and analyzing the safety and immunogenicity between domestic QIV and inactivated trivalent influenza vaccine(TIV)for people over three years old.Meta-analysis of the included literature data was performed using Stata11.0 software.Results A total of four pieces of literature were included.Compared with TIV,the combined effect value risk ratio(RR)of local and systemic reactions in QIV was 1.10(95%CI:0.88-1.38,I^(2)=0,P=0.809)and 0.97(95%CI:0.87-1.09,I^(2)=0,P=0.485),respectively.Compared with TIV,the RR of seroconversion rate(SCR)and seroprotection rate(SPR)of QIV for the same vaccine strains were 0.98-1.06 and 0.98-1.02,respectively,with no significant difference(I^(2)were 28.8%-89.9%and 0-80.2%,respectively,each P>0.05);However,there were significant differences between TIV and QIV for the B vaccine strains not included in TIV.The RR of SCR and SPR for B/Victoria were2.88(95%CI:1.75-4.74,I^(2)=98.3%,P<0.001)and 1.64(95%CI:1.16-2.33,I^(2)=99.3%,P<0.001),while for B/Yamagata were 1.89(95%CI:1.57-2.27,I^(2)=94.4%,P<0.001)and 1.15(95%CI:1.04-1.28,I^(2)=98.4%,P<0.001),respectively.Conclusion For people over three years old,domestic QIV not only produced similar safety and immunogenicity levels to TIV,but also had better immune effect against influenza B vaccine strains not included in TIV.

关 键 词：四价流感灭活疫苗 安全性 免疫原性 META分析 

分 类 号：R186[医药卫生—流行病学]