Norwegian Resource Center for AD/HD, Oslo University Hospital, Norway.
Sleep Med. 2013 Sep;14(9):867-71. doi: 10.1016/j.sleep.2013.03.020. Epub 2013 Jun 14.
BACKGROUND: From October 2009 to January 2010, approximately 470,000 children and adolescents in Norway ages 4-19 years were vaccinated with Pandemrix® against influenza A (H1N1 subtype). The vaccination coverage in this age cohort was approximately 50%. OBJECTIVES: Our study was performed to evaluate the possible association between Pandemrix® vaccination and narcolepsy in Norway. METHODS: Children and adolescents with sudden onset of excessive daytime sleepiness (EDS) and cataplexy occurring after the 2009-2010 vaccination period were registered by the National Institute of Public Health in cooperation with the Norwegian Resource Center for AD/HD, Tourette Syndrome, and Narcolepsy. RESULTS: Fifty-eight vaccinated children and adolescents (35 girls, 23 boys) ages 4-19 years (mean age, 10.5 years) were diagnosed as new cases of confirmed narcolepsy and were included in our study during 2010 and 2011. Forty-two children had onset of symptoms within 6 months after vaccination, with 12 of them having symptoms within the first 6 weeks. All had EDS, 46 had documented cataplexy, 47 had mean sleep latency less than 8 min, and 43 had two or more sleep-onset rapid eye movement sleep (SOREM) periods in multiple sleep latency tests (MSLT). Cerebrospinal fluid (CSF) hypocretin levels were measured in 41 patients, with low levels in all. Thirty seven patients that were analyzed had tissue type HLADQB1*0602. During the same period, 10 unvaccinated cases were reported (mean age, 12.5 years). CONCLUSION: The data collected during 3 years following vaccination showed a significantly increased risk for narcolepsy with cataplexy (P<.0001) and reduced CSF hypocretin levels in vaccinated children ages 4-19 years the first year after Pandemrix® vaccination, with a minimum incidence of 10 of 100,000 individuals per year. The second year after vaccination, the incidence was 1.1 of 100,000 individuals per year, which was not significantly different from the incidence of 0.5-1 of 100,000 per year in unvaccinated children during the same period.
背景：从 2009 年 10 月到 2010 年 1 月，挪威约有 47 万名 4-19 岁的儿童和青少年接种了抗流感 A（H1N1 亚型）的疫苗百利康（Pandemrix®）。该年龄段的疫苗接种覆盖率约为 50%。
目的：我们的研究旨在评估百利康（Pandemrix®）疫苗接种与挪威嗜睡症之间的可能关联。
方法：国家公共卫生研究所与挪威注意力缺陷多动障碍、图雷特综合征和嗜睡症资源中心合作，登记了在 2009-2010 年疫苗接种期间出现突发性日间嗜睡（EDS）和猝倒症的儿童和青少年。
结果：在 2010 年和 2011 年期间，有 58 名接种疫苗的儿童和青少年（35 名女孩，23 名男孩）被诊断为新确诊的嗜睡症，年龄在 4-19 岁（平均年龄为 10.5 岁）。42 名儿童在接种疫苗后 6 个月内出现症状，其中 12 名儿童在最初的 6 周内出现症状。所有患者均有 EDS，46 例有记录的猝倒症，47 例平均睡眠潜伏期少于 8 分钟，43 例在多次睡眠潜伏期试验（MSLT）中有 2 个或更多的睡眠开始快速眼动睡眠（SOREM）期。41 名患者的脑脊液（CSF）食欲素水平均较低。37 名经分析的患者具有组织类型 HLA-DQB1*0602。同期报告了 10 例未接种疫苗的病例（平均年龄 12.5 岁）。
结论：接种疫苗后 3 年期间收集的数据显示，接种疫苗的 4-19 岁儿童在接种百利康（Pandemrix®）疫苗后的第一年患伴有猝倒症的嗜睡症的风险显著增加（P<.0001），并且脑脊液食欲素水平降低，发病率为每年每 10 万人中有 10 例。接种疫苗的第二年，发病率为每年每 10 万人中有 1.1 例，与同期未接种疫苗的儿童每年每 10 万人中有 0.5-1 例的发病率相比无显著差异。
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