甲型H_1N_1流行性感冒疫苗接种安全性研究  

The Study on Safety of Influenza A(H_1N_1)Vaccination

作　　者：张国民[1] 张振国[2] 张晓曙[3] 黄卓英[4] 疏俊[5] 李顺利[6] 赵占杰[5] 杨宏[1] 许涤沙[1] 武文娣[1] 李克莉[1] 刘大卫[1] 杨忠东 肖奇友 王华庆[1] 

机构地区：[1]中国疾病预防控制中心免疫规划中心,北京100050 [2]河北省疾病预防控制中心,石家庄050021 [3]甘肃省疾病预防控制中心,兰州730000 [4]上海市疾病预防控制中心,上海200336 [5]广东省疾病预防控制中心,广州510300 [6]沧州市疾病预防控制中心,河北沧州061001 [7]中国生物技术股份有限公司,北京100029

出　　处：《中国疫苗和免疫》2012年第6期511-514,共4页Chinese Journal of Vaccines and Immunization

基　　金：国家高技术研究发展计划(863计划)项目<甲型H1N1流感疫苗规模化生产新工艺新方法的研发>子课题<甲型H1N1流感病毒裂解疫苗上市后效果和安全性评价>(编号:2010AA022910)

摘　　要：目的分析评价甲型H1N1流行性感冒(流感)(甲流)疫苗上市后大规模接种的安全性。方法 对接种甲流疫苗人群和接种季节性流感疫苗(Seasonal Influenza Vaccine,sInfV)人群开展主动监测与常规监测相结合的方式进行疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)监测。结果在18853名接种甲流疫苗人群中发生一般反应353例,发生率为18723.81/100万剂;异常反应16例,发生率为848.67/100万剂;偶合症2例。在17012名接种sInfV人群中,发生一般反应181例,发生率为10639.55/100万剂,异常反应1例,发生率为58.78/100万剂。接种甲流疫苗的一般反应(2=39.85,P<0.001)与异常反应(2=11.78,P<0.001)报告发生率均高于sInfV,差异有统计学意义。结论我国的甲流疫苗的安全性良好。Objective This study is to obtain the safety evidence of influenza A （H1N1） in a large scale vaccination practice. Method based on the national adverse events following immunization （AEFI） surveillance system, a passive searching for the AEFI after influenza A （H：N1） vaccination was carried out. Results Among 18,853 individuals vaccinated influenza A （H1Nl） vaccine, 353 common, minor reactions （reporting rate, 18,723.81 per 1,000,000 vaccinated） and 16 rare, serious reaction （reporting rate, 848.67 per 1,000,000 vaccinated）and 2 coincidental illness were reported. Among 17,012 individuals vaccinated seasonal influenza vaccine, 181 common, minor reactions （reporting rate, 10,639.55 per 1,000,000 vaccinated） and 1 rare, influenza vaccine group, the influenza A （H1N1） serious reaction were reported. Compared with the seasonal vaccinated group were reported more cases with common, minor reactions and rare, serious reaction after vaccination. The difference has significant statistics between slnfV and Influenza A （H1N1） vaccine. Conclusion The safety of Influenza A （H1N1） vaccine is good.

关 键 词：甲型H1N1流行性感冒疫苗 安全性 疑似预防接种异常反应 

分 类 号：R511.7[医药卫生—内科学] R186[医药卫生—临床医学]