中国疫苗接种后不良事件监测：过去、现在与未来
Surveillance of adverse events following immunization in China: Past, present, and future.
作者信息
Liu Dawei, Wu Wendi, Li Keli, Xu Disha, Ye Jiakai, Li Li, Wang Huaqing
机构信息
National Immunization Program, Chinese Center for Disease Control and Prevention, Beijing 100050, China.
National Immunization Program, Chinese Center for Disease Control and Prevention, Beijing 100050, China; School of Health Sciences, University of Tampere, Tampere FI-33014, Finland.
出版信息
Vaccine. 2015 Jul 31;33(32):4041-6. doi: 10.1016/j.vaccine.2015.04.060. Epub 2015 Apr 28.
Surveillance for adverse events following immunization (AEFI) is an important component of any national immunization program. In the People's Republic of China (China), a populous, middle-income country, development of an AEFI surveillance system began in 2005. In 2008, the AEFI surveillance system was implemented as a nationwide, online system and called the Chinese National AEFI Information System (CNAEFIS). Since then, CNAEFIS has provided useful, national-level data on vaccine safety. National AEFI surveillance guidelines were issued jointly by the Ministry of Health and the China Food and Drug Administration in 2010. This article reviews the development, status, and key aspects of the Chinese AEFI surveillance system, and describes challenges and future plans for vaccine safety assessment in China.
免疫接种后不良事件（AEFI）监测是任何国家免疫规划的重要组成部分。在人口众多的中等收入国家中华人民共和国（中国），AEFI监测系统于2005年开始建立。2008年，AEFI监测系统作为一个全国性的在线系统实施，并称为中国国家AEFI信息系统（CNAEFIS）。自那时以来，CNAEFIS提供了有关疫苗安全性的有用的国家级数据。2010年，卫生部和中国食品药品监督管理局联合发布了国家AEFI监测指南。本文回顾了中国AEFI监测系统的发展、现状和关键方面，并描述了中国疫苗安全性评估面临的挑战和未来计划。
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