Stratton K R, Howe C J, Johnston R B
Institute of Medicine, National Academy of Sciences, Washington, DC.
JAMA. 1994 May 25;271(20):1602-5.
In September 1993, the Institute of Medicine released a report entitled Adverse Events Associated With Childhood Vaccines: Evidence Bearing on Causality. The report examined putative serious adverse consequences associated with administration of diphtheria and tetanus toxoids; measles, mumps, and measles-mumps-rubella vaccines; oral polio vaccine and inactivated polio vaccine; hepatitis B vaccines; and Haemophilus influenzae type b (Hib) vaccines. The committee spent 18 months reviewing all available scientific and medical data, from individual case reports (published and unpublished) to controlled clinical trials. The committee found that the evidence favored the rejection of a causal relation between diphtheria and tetanus toxoids and encephalopathy, infantile spasms, and sudden infant death syndrome, and between conjugate Hib vaccines and susceptibility to Hib disease. The committee found that the evidence favored acceptance of a causal relation between diphtheria and tetanus toxoids and Guillain-Barré syndrome and brachial neuritis, between measles vaccine and anaphylaxis, between oral polio vaccine and Guillain-Barré syndrome, and between unconjugated Hib vaccine and susceptibility to Hib disease. The committee found that the evidence established causality between diphtheria and tetanus toxoids and anaphylaxis, between measles vaccine and death from measles vaccine-strain viral infection, between measles-mumps-rubella vaccine and thrombocytopenia and anaphylaxis, between oral polio vaccine and poliomyelitis and death from polio vaccine-strain viral infection, and between hepatitis B vaccine and anaphylaxis. For five vaccine-related adverse events, there was no evidence identified. For the remaining 33 vaccine-related adverse events, the evidence was inadequate to accept or reject a causal relation.
1993年9月，医学研究所发布了一份题为《与儿童疫苗相关的不良事件：因果关系证据》的报告。该报告审查了与接种白喉和破伤风类毒素、麻疹、腮腺炎以及麻疹-腮腺炎-风疹疫苗、口服脊髓灰质炎疫苗和灭活脊髓灰质炎疫苗、乙型肝炎疫苗以及b型流感嗜血杆菌（Hib）疫苗相关的假定严重不良后果。委员会花了18个月时间审查所有可用的科学和医学数据，从个别病例报告（已发表和未发表的）到对照临床试验。委员会发现，有证据支持否定白喉和破伤风类毒素与脑病、婴儿痉挛和婴儿猝死综合征之间以及结合型Hib疫苗与Hib疾病易感性之间存在因果关系。委员会发现，有证据支持接受白喉和破伤风类毒素与格林-巴利综合征和臂神经炎之间、麻疹疫苗与过敏反应之间、口服脊髓灰质炎疫苗与格林-巴利综合征之间以及非结合型Hib疫苗与Hib疾病易感性之间存在因果关系。委员会发现，有证据证实白喉和破伤风类毒素与过敏反应之间、麻疹疫苗与麻疹疫苗株病毒感染导致的死亡之间、麻疹-腮腺炎-风疹疫苗与血小板减少症和过敏反应之间、口服脊髓灰质炎疫苗与脊髓灰质炎以及脊髓灰质炎疫苗株病毒感染导致的死亡之间以及乙型肝炎疫苗与过敏反应之间存在因果关系。对于五种与疫苗相关的不良事件，未发现相关证据。对于其余33种与疫苗相关的不良事件，证据不足以接受或否定因果关系。
