REASSESSMENT OF THE ASSOCIATION BETWEEN GUILLAIN-BARRE-SYNDROME AND RECEIPT OF SWINE INFLUENZA VACCINE IN 1976-1977 - RESULTS OF A 2-STATE STUDY
REASSESSMENT OF THE ASSOCIATION BETWEEN GUILLAIN-BARRE-SYNDROME AND RECEIPT OF SWINE INFLUENZA VACCINE IN 1976-1977 - RESULTS OF A 2-STATE STUDY
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DOI：
10.1093/oxfordjournals.aje.a115973
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发表时间：
1991-05-01
影响因子：
5
通讯作者：
HUGHES, JM
中科院分区：
文献类型：
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作者：
SAFRANEK, TJ;LAWRENCE, DN;HUGHES, JM
尽管疾病控制中心最初对A/新泽西/8/76（猪流感）疫苗与格林-巴利综合征（多发性神经根神经炎）之间关系的研究显示了统计学关联，并表明这两个事件之间存在因果关系，但争议仍然存在。 为了重新评估这种关联，作者获得了1976年10月1日至1977年1月31日密歇根州和明尼苏达州所有先前报告的格林-巴利综合征成人患者的医疗记录。 为了确定以前未报告的在此期间出现症状的住院病例，作者调查了医疗保健机构。 一组神经科专家制定了格林-巴利综合征的诊断标准，然后以盲法回顾了临床记录。 在最初的疾病控制中心研究中有98名成年患者符合考虑条件，其中3名被发现按发病日期错误分类并被排除在外。 在其余95例中，28例（29%）不符合诊断标准的患者平均分布在接种组（18/60，30%）和未接种组（10/35，29%）之间。 除了其余67例符合诊断标准的病例外，还发现了6例以前未报告的病例（其中3例已接种疫苗），并将其纳入本分析。 在接种疫苗后6周内，这两个州接种疫苗的人群发生格林-巴利综合征的相对风险为7.10，与原始研究中发现的7.60的相对风险相当。 这些结果表明，在成人接种疫苗后6周内，发生格林-巴利综合征的风险增加。 在前6周，由于疫苗接种导致的格林-巴利综合征的超额病例在密歇根州为每百万接种者8.6例，在明尼苏达州为每百万接种者9.7例。 接种后6周以上，格林-巴利综合征的相对风险没有增加。
Although the original Centers for Disease Control study of the relation between A/New Jersey/8/76 (swine flu) vaccine and Guillain-Barre syndrome (polyradiculoneuritis) demonstrated a statistical association and suggested a causal relation between the two events, controversy has persisted. To reassess this association, the authors obtained medical records of all previously reported adult patients with Guillain-Barre syndrome in Michigan and Minnesota from October 1, 1976 through January 31, 1977. To identify previously unreported hospitalized cases with onset of symptoms during this period, the authors surveyed medical care facilities. A group of expert neurologists formulated diagnostic criteria for Guillain-Barre syndrome and then reviewed the clinical records in a blinded fashion. Of the 98 adult patients from the original Centers for Disease Control study eligible for consideration, three were found to have been misclassified by date of onset and were excluded. Of the remaining 95, the 28 (29%) who did not meet the diagnostic criteria were equally distributed between the vaccinated group (18 of 60, 30%) and the unvaccinated group (10 of 35, 29%). In addition to the 67 remaining cases who met the diagnostic criteria, six previously unreported cases (three of whom had been vaccinated) were found and included in this analysis. The relative risk of developing Guillain-Barre syndrome in the vaccinated population of these two states during the 6 weeks following vaccination was 7.10, comparable to the relative risk of 7.60 found in the original study. These findings suggest that there was an increased risk of developing Guillain-Barre syndrome during the 6 weeks following vaccination in adults. The excess cases of Guillain-Barre syndrome during the first 6 weeks attributed to the vaccine was 8.6 per million vaccinees in Michigan and 9.7 per million vaccinees in Minnesota. No increase in relative risk for Guillain-Barre syndrome was noted beyond 6 weeks after vaccination.