Wentz K R, Marcuse E K
Department of Epidemiology, University of Washington School of Medicine, Seattle.
Pediatrics. 1991 Mar;87(3):287-97.
A widespread impression that DTP vaccine does cause brain damage has been based first on historical precedent--smallpox and rabies vaccines were recognized as sometimes causing devastating neurologic illness; analogy to pertussis--the disease can cause encephalopathy; and more recently on anecdotal evidence, particularly case series. A noncausal relationship--coincidence--could explain the temporal relation between DTP vaccine and neurologic illness, inasmuch as DTP vaccine is given at the age of emergence of idiopathic neurologic disease. The relationship between DTP vaccine and neurologic illness lacks specificity. Case series have had an impact on both physicians' and the lay public's impression of the safety of pertussis vaccine greatly out of proportion to their scientific importance. Case series can be useful for generating hypotheses but cannot provide evidence that pertussis vaccine is causally related to acute neurologic illness or brain damage. Observational studies using cohort and ecologic designs did not find an association between DTP vaccine and serious neurologic illness, but they were not powerful enough to detect an association as rare as that observed by the NCES investigators. The case-control design offers the best chance of providing causal evidence regarding DTP vaccine and serious neurologic illness. The NCES is the only published case-control study of this issue. This study found a rare association between DTP vaccine and some types of acute neurologic illness. Bias and chance are unlikely to account entirely for the association demonstrated by the NCES. However, the association has not yet been replicated by other case-control studies. The NCES does not demonstrate that DTP vaccine causes permanent brain damage.
一种普遍的印象是，百白破疫苗确实会导致脑损伤，其依据首先是历史先例——天花和狂犬病疫苗被认为有时会引发严重的神经系统疾病；与百日咳的类比——这种疾病可导致脑病；以及最近基于轶事证据，特别是病例系列。一种非因果关系——巧合——可以解释百白破疫苗与神经系统疾病之间的时间关系，因为百白破疫苗是在特发性神经系统疾病出现的年龄接种的。百白破疫苗与神经系统疾病之间的关系缺乏特异性。病例系列对医生和普通公众对百日咳疫苗安全性的印象产生了极大影响，其影响程度与其科学重要性极不相称。病例系列有助于提出假设，但无法提供证据证明百日咳疫苗与急性神经系统疾病或脑损伤存在因果关系。采用队列和生态学设计的观察性研究未发现百白破疫苗与严重神经系统疾病之间存在关联，但它们的效力不足以检测到像国家儿童疫苗伤害法案（NCES）调查人员所观察到的那样罕见的关联。病例对照设计为提供有关百白破疫苗与严重神经系统疾病的因果证据提供了最佳机会。NCES是关于这个问题唯一已发表的病例对照研究。这项研究发现百白破疫苗与某些类型的急性神经系统疾病之间存在罕见关联。偏差和偶然性不太可能完全解释NCES所证明的这种关联。然而，其他病例对照研究尚未重复这一关联。NCES并未证明百白破疫苗会导致永久性脑损伤。
