中国药物评价2016，Vol.33Issue(4)：246-250,256,6.
“预防接种异常反应”定义辨析
Critical Analysis on the Definitions of Adverse Events Following Immunization
摘要
Abstract
“Adverse events following immunization” (AEFI)refers to extremely rare events associated with immunization.Despite their rarity,AEFI events in China often have large negative social consequences.This research investigates three definitions of AEFI:the one adopted by the WHO,the one adopted by the Chinese juridical system,and the one adopted by the Chinese disease surveillance sys-tem.It is found that the Chinese term Suspected Rare Vaccine Reactions and its English translation( AEFI) do not match.Further confu-sion is created by the disparities among Chinese terms,WHO term of AEFI and its Chinese translation.The legal definition of AEFI ( Rare Vaccine Reactions) ,which is the standard used in compensation cases in China, is narrower and stricter than the no-fault compensation principle adopted by many countries.Chinese legal definition of AEFI causes operational difficulties in gathering evidence and determining causality.It is suggested that China should adopt the WHO recommended AEFI definition in surveillance,amend the legal definitionsto lessen the requirement for evidence,adopt the“vaccine injury table” method to simplify the causality criteria,and adopt the no fault com-pensation principle in legal cases,so that more equitable compensation outcomes may be created.关键词
预防接种异常反应/定义/无过错责任/因果关联/证据Key words
Adverse events following immunization/Definition/No-fault compensation/Causal relationship/Evidence分类
医药卫生引用本文复制引用
彭向东,胡晓江..“预防接种异常反应”定义辨析[J].中国药物评价,2016,33(4):246-250,256,6.基金项目
国家自然科学基金，预防接种异常反应风险的社会扩大和社会管理（71373027）；中央高校基本科研业务费专项资金资助 （）
