北京市2011～2012年60岁以上老年人群接种流感病毒裂解疫苗的安全性评价  

Safety evaluation on influenza vaccine（split virion）in population at ages of more than 60 years during 2011~2012 in Beijing

作　　者：刘小琴 马燕丽 杨中楠 张岷 黄清霄 徐斌 陈海平 

机构地区：[1]中国生物技术股份有限公司,北京100029

出　　处：《中国生物制品学杂志》2015年第3期303-304,309,共3页Chinese Journal of Biologicals

摘　　要：目的评价北京市2011~2012年60岁以上老年人群接种北京天坛生物制品股份有限公司（以下简称天坛生物）生产的流感病毒裂解疫苗的安全性。方法通过疑似预防接种异常反应（adverse event following immunization,AEFI）信息管理系统,收集2011~2012年北京市免费接种流感病毒裂解疫苗的60岁以上老年人群接种的不良反应发生情况,采用描述性流行病学方法分析相关信息。结果接种天坛生物生产的流感病毒裂解疫苗的536 812名观察对象中,共报告AEFI 10例,其中不良反应共6例（一般反应和异常反应各3例）,发生率为1.12/10万;接种其他厂家生产的流感病毒裂解疫苗的701 820名观察对象中,共报告AEFI 21例,其中不良反应共10例（一般反应6例,异常反应4例）,发生率为1.42/10万。两组总体不良反应报告发生率、一般反应报告发生率、异常反应报告发生率差异均无统计学意义（P〉0.05）。结论天坛生物生产的流感病毒裂解疫苗具有良好的安全性,可用于相关人群的流感免疫预防。Objective To evaluate the safety of influenza vaccine（split virion）manufactured by Beijing Tiantan Biological Products Co., Ltd, in population at ages of more than 60 years during 2011 ~ 2012 in Beijing City. Methods The data on adverse events following immunization（AEFIs） cases in people at ages of more than 60 years in Beijing City during2011 to 2012, after free vaccination with influenza vaccine（split virion）, were collected by AEFI information system, and analyzed by descriptive methodology. Results Of the 536 812 recipients of vaccine manufactured by Beijing Tiantan Biological Products Co., Ltd, 10 cases of AEFIs were reported, including 6 cases of adverse reactions（3 cases of general reactions and 3 cases of abnormal reactions）, indicating an incidence of adverse reactions of 1. 12 / 100 000. However, of the 701 820 recipients of vaccines by other manufacturers, 21 cases of AEFIs were reported, including 10 cases of adverse reactions（6 cases of general reactions and 4 cases of abnormal reactions）, indicating an incidence of adverse reactions of1. 42 / 100 000. No significant differences were observed in reported incidences of total adverse reactions, general reactions and abnormal reactions（P〉0. 05）. Conclusion The influenza vaccine（split virion） manufactured by Beijing Tiantan Biological Products Co., Ltd showed high safety, which might be used for the prevention of influenza in the relevant population.

关 键 词：流感病毒裂解疫苗 疑似预防接种异常反应 安全性 

分 类 号：R373.13[医药卫生—病原生物学] R392-33[医药卫生—基础医学]