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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篇文献符合入选标准,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。
Objective To compare the safety and immunogenicity of domestic and imported, imported and imported influenza (influenza) virus lytic vaccines in Chinese population. Methods Meta-analysis was performed on randomized or fixed effect models published in literatures published between January 1996 and June 2008 in line with inclusion criteria for influenza virus lytic vaccines. Results There were 12 articles that met the inclusion criteria, 10 domestic and imported influenza virus split vaccine control trials, and 2 imported and imported influenza virus split vaccine control trials. Odds ratio (OR) = 0.81, 95% Confidence Interval (CI) of domestic and imported influenza virus split vaccine were (0.59, 1.1); OR = 0.78, 95% CI Is (0.50, 1.03). The positive rates of seroconversion in the H1N1 subtype were OR = 0.94, 95% CI was (0.78, 1.14), OR = 1.01, and the positive rate of seroconversion in the subtype H3 (H3N2) was 1.01 , 1.17). The positive rate of B (B) seroconversion was OR = 1.35, 95% CI was (0.98, 1.85). OR = 1.19, 95% CI was (0.60, 2.37); OR = 1.15 with systemic adverse reactions, 95% CI was (0.71, 1.87). The positive rates of seroconversion in H1N1 subtype were OR = 1.27, 95% CI was (0.37, 4.37), OR = 1.29, the positive rate of seroconversion in H3N2 subtype was (1.39, Positive conversion rate OR = 0.95, 95% CI (0.46,1.37). Conclusion There is no significant difference in the safety of domestic and imported, imported and imported influenza virus lysis vaccine in Chinese population and the positive rate of serum antibody.