国产与进口流行性感冒病毒裂解疫苗安全性和免疫原性的Meta分析

目的比较国产与进口、进口与进口流行性感冒（流感）病毒裂解疫苗，在中国人群中的安全性和免疫原性。方法对1996年1月-2008年6月公开发表的符合入选标准的有关流感病毒裂解疫苗的研究文献，利用随机效应模型或固定效应模型进行Meta分析。结果有12篇文献符合人选标准，国产与进口流感病毒裂解疫苗对照试验10项、进口与进口流感病毒裂解疫苗对照试验2项。国产与进口流感病毒裂解疫苗局部不良反应合并比值比（OddsRatio，OR）=0．81，95％可信区间（Confidence Interval，CI）为（0．59，1．11）；全身不良反应合并OR=0．78，95％CI为（0．50，1．03）。甲1（H1N1）亚型血清抗体阳转率合并OR=0．94，95％CI为（0．78，1．14）；甲3（H3N2）亚型血清抗体阳转率合并OR=1．01，95％CI为（0．87，1．17）；乙（B）型血清抗体阳转率合并OR=1．35，95％CI为（0．98，1．85）。进口与进口流感病毒裂解疫苗局部不良反应合并OR=1．19，95％CI为（0．60，2．37）；全身不良反应合并OR=1．15，95％CI为（0．71，1．87）。H1N1亚型血清抗体阳转率合并OR=1．27，95％CI为（0．37，4．37）；H3N2亚型血清抗体阳转率合并OR=1．29，95％CI为（0．39，4．33）；B型血清抗体阳转率合并OR=0．95，95％CI为（0．46，1，37）。结论国产与进口、进口与进口流感病毒裂解疫苗在中国人群中的安全性和血清抗体阳转率差异均无显著的统计学意义。

The Meta Analysis on the Safety and Immunogenicity of Domestic and Imported Split Influenza Virus Vaccines

Objective To compare the safety and immunogenicity between domestic and imported,imported and imported split influenza virus vaccine in Chinese population. Methods The published studies during January 1996 and June 2008 on the comparison between split influenza virus vaccine were screened and evaluated. The meta analysis was performed on safety and immu- nogenicity using fixed model or random model according the heterogeneity of the studies. Results 12 studies which were all random controlled trials between split vaccine were included. 10 trials were between domestic and imported vaccine, and 2 trials were between imported and imported vaccine. For 10 domestic and imported vaccine trials,the local reaction pooled OR=0. 81,95% CI （0. 59,1.11） ;the systemic reaction the pooled OR=0. 78,95% CI （0.50,1.03） ;the H1N1 subtype seroconversion pooled OR= 0. 94,95% CI （0. 78,1.14） ; the HaN2 subtype seroconversion pooled OR =1.01,95% CI （0.87,1.17）;the B type seroconversion total OR= 1.35,95% CI （0.98,1.85）. For 2 imported and imported vaccine trials, the local reaction pooled OR = 1.19, 95% CI （0.60,2.37）;the systemic reaction the pooled OR =1.15,95% CI （0. 71,1. 87） ; the H1N1 subtype seroconversion pooled OR= 1.27,95% CI （0.37,4.37）;the H3N2 subtype sero- conversion pooled OR = 1.29,95M CI （0.39,4.33） ; the B type seroconversion pooled OR =0.95,95% CI （0.46,1.37 There were no statistical ）. Conclusions difference on the safety and immunogenicity between domestic and imported, imported and imported split influenza vaccine in Chinese population.