Oberle Doris, Drechsel-Bäuerle Ursula, Schmidtmann Irene, Mayer Geert, Keller-Stanislawski Brigitte
Department Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
IMBEI Institute of Medical Biometry, Epidemiology and Informatics, Johannes Gutenberg University of Mainz, Germany.
Sleep. 2015 Oct 1;38(10):1619-28. doi: 10.5665/sleep.5060.
Following the 2009 pandemic, reports of an association between an AS03 adjuvanted H1N1 pandemic influenza vaccine and narcolepsy were published. Besides determining background incidence rates for narcolepsy in Germany this study aimed at investigating whether there was a change in incidence rates of narcolepsy between the pre-pandemic, pandemic, and the post-pandemic period on the population level.
Retrospective epidemiological study on the incidence of narcolepsy with additional capture-recapture analysis.
German sleep centers.
Eligible were patients with an initial diagnosis of narcolepsy (ICD10 Code G47.4) within the period from January 1, 2007 to December 31, 2011.
None; observational study.
A total of 342 sleep centers were invited to participate in the study. Adequate and suitable data were provided by 233 sleep centers (68.1%). A total of 1,198 patients with an initial diagnosis of narcolepsy within the observed period were included, of whom 106 (8.8%) were children and adolescents under the age of 18 years and 1,092 (91.2%) were adults. In children and adolescents, the age-standardized adjusted incidence rate significantly increased from 0.14/100,000 person-years in the pre-pandemic period to 0.50/100,000 person-years in the post-pandemic period (incidence density ratio, IDR 3.57; 95% CI 1.94-7.00). In adults, no significant change was detectable. This increase started in spring 2009.
For the years 2007-2011, valid estimates for the incidence of narcolepsy in Germany were provided. In individuals under 18, the incidence rates continuously increased from spring 2009.
2009年流感大流行之后,有报告称一种含AS03佐剂的H1N1大流行性流感疫苗与发作性睡病之间存在关联。除了确定德国发作性睡病的背景发病率外,本研究旨在调查在人群层面上,大流行前、大流行期间和大流行后发作性睡病的发病率是否有变化。
关于发作性睡病发病率的回顾性流行病学研究,并进行额外的捕获-再捕获分析。
德国睡眠中心。
符合条件的是在2007年1月1日至2011年12月31日期间初次诊断为发作性睡病(ICD10编码G47.4)的患者。
无;观察性研究。
共邀请了342个睡眠中心参与研究。233个睡眠中心(68.1%)提供了充分且合适的数据。在观察期内,共有1198例初次诊断为发作性睡病的患者被纳入研究,其中106例(8.8%)为18岁以下的儿童和青少年,1092例(91.2%)为成年人。在儿童和青少年中,年龄标准化调整发病率从大流行前的0.14/10万人口年显著增加到大流行后的0.50/10万人口年(发病密度比,IDR 3.57;95%置信区间1.94 - 7.00)。在成年人中,未检测到显著变化。这种增加始于2009年春季。
提供了2007 - 2011年德国发作性睡病发病率的有效估计值。在18岁以下个体中,发病率自2009年春季起持续上升。