流行性乙型脑炎减毒活疫苗和灭活疫苗上市后预防接种安全性的比较分析  

Comparative Study on Post-marketing Immunization Safety of Live Japanese Encephalitis Vaccine and Inactivated Japanese Encephalitis Vaccine in China

作　　者：刘大卫[1] 郭飚[1] 曹玲生[1] 王华庆[1] 梁晓峰[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

出　　处：《中国疫苗和免疫》2008年第4期292-296,共5页Chinese Journal of Vaccines and Immunization

摘　　要：目的评价中国（未包括香港、澳门特别行政区和台湾地区）流行性乙型脑炎减毒活疫苗（Japanese Encephalitis Vaccine，Live；JEV-1）和流行性乙型脑炎灭活疫苗（Japanese Encephalitis Vaccine，Inactivated；JEV-1）上市后预防接种的安全性。方法通过全国疑似预防接种异常反应（Adverse Events Following Immunization，AEFI）监测系统，收集9个省（自治区、直辖市）2005-2006年JEV-1和JEV-i严重不良反应的监测数据，采用描述性方法对两种疫苗不良反应的发生特征进行比较分析。结果中国JEV-1和JEV-i上市后，严重不良反应总报告发生率分别为11．4／100万剂和22．0／100万剂；临床损害均以过敏性皮疹、发热和热性惊厥为主，且第1剂反应危险性高。JEV-1和JEV-i聚集性反应发生率分别为1．2／100万剂和3．8／100万剂;JEV-1发生聚集性反应的危险性高于JEV-1。结论JEV-1和JEV-i上市后均具有较好的预防接种安全性；研究显示JEV-1安全性优于JEV-i；建议儿童常规免疫优先选择JEV-1。Objective The study was to evaluate the post-marketing immunization safety of rive Japanese encephalitis vaccine（JEV-1）and inactivated Japanese encephalitis vaccine（JEV-1）in China. Methods Through National Surveillance System for Adverse Events Following Immunization （AEFI） ,serious AEFI cases were collected in 9 provinces, during 2005-2006 and the occurrence features of AEFIs were analyzed by using descriptive methodology. Results The overall incidence rates of serious AEFIs for post marketing JEV-1 and JEV-1 were 11.4 and 22.0 per 1 000 000 doses,respectively. Anaphylactic rash, fever and febrile convulsion dominated both JEV-1 and JEV-1 AEFIs. The first dose of immunization was the highest risk for the AEFI occurrence. The estimated incidence rates of AEFI clusters for JEV-1 and JEV-i were 1.2 and 3.8 per 1 000 000 doses, respectively,with higher risk in JEV-i than in JEV-1. Conclusions Both JEV-1 and JEV-i have good immunization safety. The study indicated that the safety of JEV-1 was better than that of JEV-i. It is recommended that JEV-1 is the first choice in the routine immunization for eligible children.

关 键 词：预防接种 安全性 流行性乙型脑炎减毒活疫苗 流行性乙型脑炎灭活疫苗 

分 类 号：R186[医药卫生—流行病学]