Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden.
Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm, Sweden.
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DOI：
10.1136/bmj.d5956
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发表时间：
2011-10-12
期刊：
影响因子：
--
通讯作者：
Granath F
中科院分区：
文献类型：
--
作者：
Bardage C;Persson I;Ortqvist A;Bergman U;Ludvigsson JF;Granath F
目的研究接种Pandemrix（GlaxoSmithKline，Middlesex，UK）抗甲型H1N1流感疫苗的人群与未接种疫苗的人群相比，在8-10个月内发生神经系统和自身免疫性疾病的风险。设计回顾性队列研究，将大流行疫苗接种的个体化数据与斯德哥尔摩县的住院和专科医疗保健利用数据库联系起来，以在大流行期间和之后进行随访。背景是瑞典的斯德哥尔摩县。人口2009年10月1日在斯德哥尔摩县登记并自1998年1月1日起居住在该地区的所有人; 1 024 019人接种了H1N1疫苗，921 005人未接种疫苗。主要结果测量根据欧洲药品管理局监测使用ICD-10编码定义的特别关注的不良事件的策略进行的神经和自身免疫诊断，所述不良事件包括格林-巴利综合征、贝尔麻痹、多发性硬化、多发性神经病、麻醉或感觉减退、感觉异常、发作性睡病（添加）和自身免疫性疾病，如类风湿性关节炎、炎症性肠病和1型糖尿病;和短期死亡率。结果：在调整年龄、性别、社会经济地位和医疗保健利用率后，与未接种疫苗的人相比，接种疫苗的人发生贝尔麻痹（危害比1.25，95%置信区间1.06至1.48）和感觉异常（1.11，1.00至1.23）的风险较低。格林-巴利综合征、多发性硬化症、1型糖尿病和类风湿性关节炎的风险保持不变。在接种运动早期（2009年10月1日起45天内）接种疫苗的人群中，感觉异常和炎症性肠病的风险显著增加;在接种疫苗后的前六周内，风险增加。在早期阶段接种疫苗的人的死亡风险比未接种疫苗的人略低（0.94，0.91至0.98），而在晚期阶段接种疫苗的人的死亡率总体降低（0.68，0.64至0.71）。这些关联可能是真实的，也可能部分或全部由残余混杂因素解释。结论：Pandemrix的安全性在8-10个月的随访中得到了令人放心的结果--值得注意的是，格林-巴利综合征、多发性硬化症、1型糖尿病或类风湿性关节炎的风险没有变化。在接种疫苗后，贝尔麻痹、感觉异常和炎症性肠病的相对风险显著增加，主要发生在接种运动的早期阶段。少数儿童和青少年发作性睡病排除了任何有意义的结论。
Objective To examine the risk of neurological and autoimmune disorders of special interest in people vaccinated against pandemic influenza A (H1N1) with Pandemrix (GlaxoSmithKline, Middlesex, UK) compared with unvaccinated people over 8-10 months. Design Retrospective cohort study linking individualised data on pandemic vaccinations to an inpatient and specialist database on healthcare utilisation in Stockholm county for follow-up during and after the pandemic period. Setting Stockholm county, Sweden. Population All people registered in Stockholm county on 1 October 2009 and who had lived in this region since 1 January 1998; 1 024 019 were vaccinated against H1N1 and 921 005 remained unvaccinated. Main outcome measures Neurological and autoimmune diagnoses according to the European Medicines Agency strategy for monitoring of adverse events of special interest defined using ICD-10 codes for Guillain-Barré syndrome, Bell’s palsy, multiple sclerosis, polyneuropathy, anaesthesia or hypoaesthesia, paraesthesia, narcolepsy (added), and autoimmune conditions such as rheumatoid arthritis, inflammatory bowel disease, and type 1 diabetes; and short term mortality according to vaccination status. Results Excess risks among vaccinated compared with unvaccinated people were of low magnitude for Bell’s palsy (hazard ratio 1.25, 95% confidence interval 1.06 to 1.48) and paraesthesia (1.11, 1.00 to 1.23) after adjustment for age, sex, socioeconomic status, and healthcare utilisation. Risks for Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, and rheumatoid arthritis remained unchanged. The risks of paraesthesia and inflammatory bowel disease among those vaccinated in the early phase (within 45 days from 1 October 2009) of the vaccination campaign were significantly increased; the risk being increased within the first six weeks after vaccination. Those vaccinated in the early phase were at a slightly reduced risk of death than those who were unvaccinated (0.94, 0.91 to 0.98), whereas those vaccinated in the late phase had an overall reduced mortality (0.68, 0.64 to 0.71). These associations could be real or explained, partly or entirely, by residual confounding. Conclusions Results for the safety of Pandemrix over 8-10 months of follow-up were reassuring —notably, no change in the risk for Guillain-Barré syndrome, multiple sclerosis, type 1 diabetes, or rheumatoid arthritis. Relative risks were significantly increased for Bell’s palsy, paraesthesia, and inflammatory bowel disease after vaccination, predominantly in the early phase of the vaccination campaign. Small numbers of children and adolescents with narcolepsy precluded any meaningful conclusions.
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影响因子：
11.8
作者：
Ortqvist, Ake;Berggren, Ingela;Svenungsson, Bo
通讯作者：
Svenungsson, Bo
影响因子：
120.7
作者：
Haber, P;DeStefano, F;Chen, RT
通讯作者：
Chen, RT
影响因子：
3.4
作者：
Lofgren, S.;Ljunggren, G.;Brommels, M.
通讯作者：
Brommels, M.
影响因子：
5
作者：
SAFRANEK, TJ;LAWRENCE, DN;HUGHES, JM
通讯作者：
HUGHES, JM
DOI：
10.4161/hv.2790
发表时间：
2006-05-01
期刊：
HUMAN VACCINES
影响因子：
--
作者：
Stowe, Julia;Andrews, Nick;Miller, Elizabeth
通讯作者：
Miller, Elizabeth