Miller E, Waight P, Farrington P
PHLS Communicable Disease Surveillance Centre, London, UK.
Dev Biol Stand. 1998;95:235-43.
The objectives of post-licensure surveillance are to identify rare or novel adverse events, estimate their rate of occurrence and distinguish those that are causally related to vaccination. Evidence of causality is based on biological plausibility supported by laboratory evidence of vaccine involvement and/or a statistically significant excess of events in the post-vaccination period. Passive reporting systems have methodological limitations, particularly for ascertaining reliable adverse event rates and investigating causal relationships. In Canada, an active surveillance system (IMPACT) has been established in sentinel paediatric hospitals where nurses scrutinise all admissions for conditions conforming to a defined set of adverse events. While ascertainment of events resulting in hospital admission should be complete, causality is difficult to assess without information on the incidence of such events outside the post-vaccination risk period. The use of computerised data bases which link clinical events with immunisation records have allowed the risk of events such as convulsions attributable to DTP, MMR and Hib vaccines to be defined. The record linkage method promises to be a useful method for routine surveillance of vaccine safety.
上市后监测的目的是识别罕见或新出现的不良事件，估计其发生率，并区分那些与疫苗接种有因果关系的事件。因果关系的证据基于生物学合理性，并得到疫苗相关实验室证据和/或接种疫苗后时期事件统计学上显著过量的支持。被动报告系统存在方法学上的局限性，特别是在确定可靠的不良事件发生率和调查因果关系方面。在加拿大，已在定点儿科医院建立了一个主动监测系统（IMPACT），护士在这些医院仔细检查所有符合一组定义不良事件的入院情况。虽然导致住院的事件的确定应该是完整的，但如果没有接种疫苗后风险期之外此类事件发生率的信息，就很难评估因果关系。将临床事件与免疫记录相链接的计算机数据库的使用，使得能够确定诸如白百破、麻疹腮腺炎风疹和b型流感嗜血杆菌疫苗所致惊厥等事件的风险。记录链接方法有望成为疫苗安全性常规监测的一种有用方法。
