Farrington P, Pugh S, Colville A, Flower A, Nash J, Morgan-Capner P, Rush M, Miller E
Public Health Laboratory Service Statistics Unit, Communicable Disease Surveillance Center, London, UK.
Lancet. 1995 Mar 4;345(8949):567-9. doi: 10.1016/s0140-6736(95)90471-9.
We describe a new method for active post-marketing surveillance of vaccine safety based on patient records. We studied the association between diphtheria/tetanus/pertussis (DTP) vaccination and febrile convulsion, and between measles/mumps/rubella (MMR) vaccination and febrile convulsion and idiopathic thrombocytopenic purpura (ITP) in five district health authorities in England by linking vaccination records with computerised hospital admission records. We found an increased relative incidence for convulsions 0-3 days after DTP vaccination. The effect was limited to the third dose of vaccine for which the attributable risk (all ages) was 1 in 12,500 doses. Completion of vaccination by 4 months instead of 10 months after the change in the UK to an accelerated immunisation schedule may have resulted in a 4-fold decrease in febrile convulsions attributable to DTP vaccine. 67% of admissions for a convulsion 6-11 days after MMR vaccination were attributable to the measles component of the vaccine (risk 1 in 3000 doses). An excess of admissions for a convulsion 15-35 days after MMR vaccination was found only for vaccines containing the Urabe mumps strain (1 in 2600 Urabe doses). There was a causal association between MMR vaccination and ITP resulting in admission 15-35 days subsequently; there was no evidence of a mumps strain-specific effect. The estimated absolute risk of 1 in 24,000 doses was 5 times that calculated from cases passively reported by clinicians. This finding emphasises the need for active surveillance of adverse events. The record linkage method that we used is an effective way to identify vaccine-attributable adverse events.
我们描述了一种基于患者记录进行疫苗安全性上市后主动监测的新方法。我们通过将疫苗接种记录与计算机化的医院入院记录相链接，研究了英格兰五个地区卫生当局中白喉/破伤风/百日咳（DTP）疫苗接种与热性惊厥之间的关联，以及麻疹/腮腺炎/风疹（MMR）疫苗接种与热性惊厥和特发性血小板减少性紫癜（ITP）之间的关联。我们发现DTP疫苗接种后0至3天惊厥的相对发病率有所增加。这种影响仅限于第三剂疫苗，其归因风险（所有年龄段）为每12,500剂中有1例。在英国改为加速免疫程序后，4个月而非10个月完成疫苗接种可能使DTP疫苗所致热性惊厥减少了4倍。MMR疫苗接种后6至11天因惊厥入院的病例中，67%可归因于疫苗的麻疹成分（风险为每3000剂中有1例）。仅在含有腮腺炎病毒株Urabe的疫苗中发现MMR疫苗接种后15至35天因惊厥入院的病例过多（每2600剂Urabe疫苗中有1例）。MMR疫苗接种与随后15至35天因ITP入院之间存在因果关联；没有证据表明存在腮腺炎病毒株特异性影响。估计每24,000剂中的绝对风险是临床医生被动报告病例计算得出风险的5倍。这一发现强调了对不良事件进行主动监测的必要性。我们使用的记录链接方法是识别疫苗所致不良事件的有效途径。
