作　　者： (蔡婷）; (杨羽）; (王亚丽）; (董铎）; (詹思延）;

机构地区： 北京大学公共卫生学院,北京100191

出　　处： 《中国药物警戒》 2017年第8期464-469,共6页

摘　　要： 疫苗主动监测是20世纪末为弥补传统被动监测的不足而出现的上市后安全性监测新模式。全球范围内,上市后安全性主动监测尚处于初步发展阶段,其含义理解和功能定位不尽一致,具体开展形式也多种多样。目前部分发达国家已构建了较为完善的疫苗上市后安全性主动监测系统并取得了一定成果。主动监测在疫苗安全性监测中的作用得到广泛认可,成为未来上市后安全性监测模式的主要发展趋势。我国现有的疫苗上市后安全性监测模式仍为被动监测,对开展主动监测的需求日益凸显。了解疫苗上市后安全性主动监测的发展,认识其不同的含义和定位,比较不同的开展形式,借鉴现有的主动监测系统的成功经验,将有助于我国今后构建切实可行的疫苗上市后安全性主动监测体系。 In the late 20 th century, active surveillance occurred as a novel method of post-marketing surveillance for vaccine safety, to recover the deficiency of traditional passive surveillance. Nowadays, active post-marketing surveillance is still in an initial stage of development, with various definitions and performance around the world. There have been active surveillance systems of vaccine safety established in developed countries and their achievements indicate the great advantages of active surveillance method. However, the primary surveillance mode of vaccine safety in China is currently in a passive way, as the most of developing countries. In view of the increasing amountof new vaccines and the enhanced public attention on vaccine safety, there is an insistent demand for conducting active surveillance for vaccine safety in Chinese population. This study will reviewthe development of active post-marketing surveillance for vaccine safety, analyze the different modes of active surveillance and explore the typical surveillance systems, with the aim to accelerate the foundation of active surveillance system for vaccine safety in China.

关 键 词： 疫苗 安全性 上市后监测 主动监测 综述