甲型H1N1流行性感冒裂解疫苗的安全性分析  

Safety of influenza A(H1N1) vaccine(Split,Inactivated)

作　　者：安婧[1] 张晓曙[1] 梁雪枫[1] 李慧[1] 

机构地区：[1]甘肃省疾病预防控制中心免疫规划科,兰州730000

出　　处：《安徽医科大学学报》2013年第3期249-251,共3页Acta Universitatis Medicinalis Anhui

基　　金：国家高技术研究发展计划(863)项目(编号:2010AA022910)

摘　　要：目的了解甲型H1N1流感裂解疫苗疑似预防接种异常反应(AEFI)的特征,评价甲型H1N1流行性感冒(简称甲流)裂解疫苗安全性。方法通过中国免疫规划监测信息管理系统收集甘肃省接种甲型H1N1流感裂解疫苗后报告的AEFI个案数据,采用描述性分析方法、应用Poisson分布检验对相关指标进行流行病学分析。结果①AEFI报告总发生率为36.28/10万,不良反应发生率为29.53/10万;②女性AEFI报告发生率高于男性(P<0.01),5岁以下儿童AEFI报告发生率高于其他年龄组(P<0.05);学生AEFI报告发生率较其他人群高(P<0.01);③AEFI多发生在接种后1 d之内,临床表现主要以发热、红肿、硬结为主。结论接种甲型H1N1流感裂解疫苗后,发生AEFI以一般反应为主,严重反应发生率较低。甲型H1N1流感裂解疫苗安全性相对较高。Objective To analyze the features of the adverse events following immunization （AEFI） in influenza A （H1N1） vaccine （Split,Inactivated）, and to evaluate the safety of the vaccine. Methods The AEFI data were collected through China Information System for NIP Surveillance. The data were analyzed using descriptive study and statistical analysis. Results （1） The rate of the reported AEFI incidence was 36.28/100 000 ; The rate of Adverse Reaction Following Immunization incidence was 29.53/100 000 ; （2） There were significant differences in the rate of reported AEFI incidence between the male and the female （P 〈0.01 ）. The rate of the reported AEFI incidence in children under 5 years old was significantly above the other age groups （ P 〈 0.05 ）, which was also true with students when compared with other occupational groups. （3） Plenty of cases happened within 1 day after vaccination, with the typical clinical diagnosis as fever, flare and induration. Conclusion Most reactions to influenza A H1N1 vaccine are mild, with rare serious adverse reaction. Influenza A H1N1 vaccine is relatively secure.

关 键 词：甲型H1N1流行性感冒疫苗 疑似预防接种异常反应 安全性 监测 

分 类 号：R186[医药卫生—流行病学] R511.7[医药卫生—公共卫生与预防医学]