Risk of presentation to hospital with epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study.
Risk of presentation to hospital with epileptic seizures after vaccination with monovalent AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine (Pandemrix): self controlled case series study.
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DOI：
10.1136/bmj.e7594
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发表时间：
2012-12-18
期刊：
影响因子：
--
通讯作者：
Sparén P
中科院分区：
文献类型：
--
作者：
Arnheim-Dahlström L;Hällgren J;Weibull CE;Sparén P
目的评估单价AS03佐剂大流行性a /H1N1流感疫苗（Pandemrix; Glaxo SmithKline，瑞典）接种后癫痫患者和非癫痫患者癫痫发作的风险。设计基于自控制案例系列的寄存器。三个瑞典县（源人口75万）。参与者373 398人（年龄0-106岁，中位数41.2）接种了疫苗。在任何剂量疫苗接种前90天至接种后90天内的任何时间，为住院或门诊诊断的癫痫发作患者接种疫苗。主要结局指标终点为以癫痫发作为主要诊断的住院或门诊医院护理。相对发病率的效应估计计算为暴露后一段时间的癫痫发作发生率相对于接种前后两个对照期的癫痫发作发生率。结果859人在研究期间发生癫痫发作。在1-7天的危险期（其中第1天为接种疫苗日），既往诊断为癫痫的患者癫痫发作风险未增加（相对发病率1.01,95%可信区间0.74至1.39），无癫痫患者癫痫发作风险无显著降低（0.67,0.27至1.65）。在第二个风险期（第8-30天），没有癫痫的人癫痫发作的风险没有显著增加（1.11,0.73至1.70），但癫痫患者的风险没有增加（1.00,0.83至1.21）。结论：本研究未发现接种单价AS03佐剂H1N1流感大流行疫苗后癫痫发作住院风险增加的证据。
Objective To assess the risk of epileptic seizures in people with and without epilepsy after vaccination with a monovalent AS03 adjuvanted pandemic A/H1N1 influenza vaccine (Pandemrix; Glaxo SmithKline, Sweden). Design Register based self controlled case series. Setting Three Swedish counties (source population 750 000). Participants 373 398 people (age 0-106, median 41.2) who were vaccinated. Vaccinated people with epileptic seizures, diagnosed as inpatients or outpatients, at any time from 90 days before until 90 days after any dose of vaccine. Main outcome measures Endpoints were admission to hospital or outpatient hospital care with epileptic seizures as the main diagnosis. The effect estimate of relative incidence was calculated as the incidence of epileptic seizures in period after exposure relative to the incidence of epileptic seizures in two control periods, one before and one after vaccination. Results 859 people experienced epileptic seizures during the study period. There was no increased risk of seizures in people with previously diagnosed epilepsy (relative incidence 1.01, 95% confidence interval 0.74 to 1.39) and a non-significant decrease in risk for people without epilepsy (0.67, 0.27 to 1.65) during the day 1-7 risk period (where day 1 is the day of vaccination). In a second risk period (day 8-30), there was a non-significant increased risk of seizures in people without epilepsy (1.11, 0.73 to 1.70) but no increase in risk for those with epilepsy (1.00, 0.83 to 1.21). Conclusions This study found no evidence of an increase in risk of presentation to hospital with epileptic seizures after vaccination with a monovalent AS03 adjuvanted pandemic H1N1 influenza vaccine.
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影响因子：
5.5
作者：
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影响因子：
4.8
作者：
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通讯作者：
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