Howson C P, Fineberg H V
Institute of Medicine, National Academy of Sciences, Washington, DC 20418.
JAMA. 1992 Jan 15;267(3):392-6.
In August 1991, the Institute of Medicine released a report entitled Adverse Effects of Pertussis and Rubella Vaccines, which examined 18 adverse events in relation to diphtheria-tetanus-pertussis (DTP) vaccine and four adverse events in relation to the currently used rubella vaccine strain, RA 27/3. The committee spent 20 months reviewing a wide range of information sources, including case series and individual case reports, both published and unpublished, epidemiologic studies, studies in animals, and other laboratory studies. The committee found that the evidence indicates a causal relation between DTP vaccine and anaphylaxis and between the pertussis component of DTP vaccine and extended periods of inconsolable crying or screaming. The committee also reported that the evidence indicates a causal relation between the rubella vaccine and acute arthritis in adult women. The committee found the available evidence weaker but still consistent with a causal relation between DTP vaccine and two conditions--acute encephalopathy and hypotonic, hyporesponsive episodes--and between rubella vaccine and chronic arthritis in adult women. Estimated incidence rates of these adverse events following vaccination are provided, where possible. The committee found that the evidence does not indicate a causal relation between the DTP vaccine and infantile spasms, hypsarrhythmia, Reye's syndrome, and sudden infant death syndrome. The committee found insufficient evidence to indicate either the presence or absence of a causal relation between DTP vaccine and chronic neurologic damage, aseptic meningitis, erythema multiforme or other rash, Guillain-Barré syndrome, hemolytic anemia, juvenile diabetes, learning disabilities and attention-deficit disorder, peripheral mononeuropathy, or thrombocytopenia, and between rubella vaccine and radiculoneuritis and other neuropathies or thrombocytopenic purpura. The committee's evaluative methods are briefly described and a summary of research needs is provided.
1991年8月，医学研究所发布了一份题为《百日咳和风疹疫苗的不良反应》的报告，该报告研究了与白喉-破伤风-百日咳（DTP）疫苗相关的18种不良事件以及与目前使用的风疹疫苗株RA 27/3相关的4种不良事件。委员会花了20个月时间审查了广泛的信息来源，包括已发表和未发表的病例系列和个案报告、流行病学研究、动物研究以及其他实验室研究。委员会发现，有证据表明DTP疫苗与过敏反应之间以及DTP疫苗的百日咳成分与长时间难以安抚的哭闹或尖叫之间存在因果关系。委员会还报告说，有证据表明风疹疫苗与成年女性的急性关节炎之间存在因果关系。委员会发现现有证据较弱，但仍与DTP疫苗与两种病症——急性脑病和低渗、低反应性发作——以及风疹疫苗与成年女性的慢性关节炎之间的因果关系一致。在可能的情况下，提供了接种疫苗后这些不良事件的估计发病率。委员会发现，没有证据表明DTP疫苗与婴儿痉挛症、高峰节律紊乱、瑞氏综合征和婴儿猝死综合征之间存在因果关系。委员会发现证据不足，无法表明DTP疫苗与慢性神经损伤、无菌性脑膜炎、多形红斑或其他皮疹、格林-巴利综合征、溶血性贫血、青少年糖尿病、学习障碍和注意力缺陷障碍、周围单神经病或血小板减少症之间是否存在因果关系，以及风疹疫苗与神经根神经炎和其他神经病变或血小板减少性紫癜之间是否存在因果关系。简要描述了委员会的评估方法，并提供了研究需求总结。
