Kim Woo Jung, Lee Sang Don, Lee Eun, Namkoong Kee, Choe Kang-Won, Song Joon Young, Cheong Hee Jin, Jeong Hye Won, Heo Jung Yeon
Department of Psychiatry, Eulji Addiction Institute, Gangnam Eulji Hospital, Eulji University, Seoul, South Korea; Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Department of Psychiatry, The Armed Forces Capital Hospital, Seongnam, Gyeonggi, South Korea.
Vaccine. 2015 Sep 11;33(38):4868-72. doi: 10.1016/j.vaccine.2015.07.055. Epub 2015 Aug 1.
Previous reports mostly from Europe suggested an association between an occurrence of narcolepsy and an influenza A(H1N1)pdm09 vaccine adjuvanted with AS03 (Pandemrix(®)). During the 2009 H1N1 pandemic vaccination campaign, the Korean military performed a vaccination campaign with one type of influenza vaccine containing MF59-adjuvants. This study was conducted to investigate the background incidence rate of narcolepsy in South Korean soldiers and the association of the MF59-adjuvanted vaccine with the occurrence of narcolepsy in a young adult group.
To assess the incidence of narcolepsy, we retrospectively reviewed medical records of suspicious cases of narcolepsy in 2007-2013 in the whole 20 military hospitals of the Korean military. The screened cases were classified according to the Brighton Collaboration case definition of narcolepsy. After obtaining the number of confirmed cases of narcolepsy per 3 months in 2007-2013, we compared the crude incidence rate of narcolepsy before and after the vaccination campaign.
We included 218 narcolepsy suspicious cases in the initial review, which were screened by the diagnostic code on the computerized disease registry in 2007-2013. Forty-one cases were finally diagnosed with narcolepsy in 2007-2013 (male sex, 95%; median age, 21 years). The average background incidence rate of narcolepsy in Korean soldiers was 0.91 cases per 100,000 persons per year. During the 9 months before vaccination implementation (April to December 2009), 6 narcolepsy cases occurred, whereas during the next 9 months (January to September 2010) including the 3-month vaccination campaign, 5 cases occurred.
The incidence of narcolepsy in South Korean soldiers was not increased after the pandemic vaccination campaign using the MF59-adjuvanted vaccine. Our results suggest that the MF59-adjuvanted H1N1 vaccine did not contribute to the occurrence of narcolepsy in this young adult group.
此前大多来自欧洲的报告表明,甲型H1N1pdm09流感疫苗(含AS03佐剂,商品名“大流行疫苗”)与发作性睡病的发生有关。在2009年甲型H1N1流感大流行疫苗接种活动期间,韩国军队开展了一项接种含MF59佐剂流感疫苗的活动。本研究旨在调查韩国士兵发作性睡病的背景发病率,以及MF59佐剂疫苗与年轻成年人群发作性睡病发生之间的关联。
为评估发作性睡病的发病率,我们回顾性查阅了2007 - 2013年韩国军队全部20家军事医院发作性睡病疑似病例的医疗记录。筛选出的病例根据布莱顿协作组发作性睡病病例定义进行分类。在获取2007 - 2013年每3个月确诊的发作性睡病病例数后,我们比较了疫苗接种活动前后发作性睡病的粗发病率。
我们在初步审查中纳入了2007 - 2013年通过计算机疾病登记系统诊断编码筛选出的218例发作性睡病疑似病例。2007 - 2013年最终确诊41例发作性睡病(男性占95%;中位年龄21岁)。韩国士兵发作性睡病的平均背景发病率为每年每10万人0.91例。在疫苗接种实施前的9个月(2009年4月至12月),发生6例发作性睡病病例,而在接下来包括3个月疫苗接种活动的9个月(2010年1月至9月),发生5例。
使用MF59佐剂疫苗进行大流行疫苗接种活动后,韩国士兵发作性睡病的发病率并未增加。我们的结果表明,MF59佐剂甲型H1N1流感疫苗并未导致该年轻成年人群发作性睡病的发生。