疫苗上市后安全性主动监测及其流行病学研究方法  

Systematic Review of Active Surveillance and Related Epidemiological Study Methods for the Evaluation of Post-marketing Vaccine Safety

作　　者：武文娣[1] 刘大卫[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》2016年第2期221-229,237,共10页Chinese Journal of Vaccines and Immunization

摘　　要：疫苗上市后安全性评估的方法主要包括疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的被动监测、主动监测和特殊的流行病学研究等。被动监测旨在发现疫苗安全性信号,提出研究假设。在被动监测基础上,主动监测及相关流行病学研究方法能对发现的疫苗安全性信号进行验证,并评估关注的AEFI的发生风险。本文通过文献检索,对常见的AEFI主动监测类型和相关的流行病学研究方法进行综述,为中国开展疫苗上市后安全性评估工作提供参考依据。Methods for evaluation of post-marketing vaccine safety include passive surveillance,active surveillance and related epidemiological studies on adverse events following immunization（AEFI）.The primary aim of AEFI passive surveillance is to detect vaccine safety signals,and generate hypotheses.Based on passive surveillance,active surveillance and related epidemiological studies can be used to verify vaccine safety signals and evaluate the risk of adverse events of special interest.After reviewing literatures,this article summarizes common active surveillance systems and related epidemiological studies on the evaluation of post-marketing vaccine safety.

关 键 词：疫苗上市后安全性 评估 主动监测 流行病学研究 

分 类 号：R186[医药卫生—流行病学]