Dipartimento Universitario Di Neuroscienze, Università Cattolica del Sacro Cuore, Rome, Italy.
Neurologia, Dipartimento Di Scienze Dell'invecchiamento, Neurologiche, Ortopediche E Della Testa-Collo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Neurol Sci. 2022 Aug;43(8):4627-4634. doi: 10.1007/s10072-022-06100-0. Epub 2022 May 2.
To investigate the safety and tolerability of COVID-19 vaccines in people with epilepsy (PwE).
In this multicentric observational cohort study, we recruited adult patients (age > 18 years old) with epilepsy who attended the Outpatient Epilepsy Clinic from 1st July to 30th October 2021. We administered to the patients a structured questionnaire and interview on demographic and epilepsy characteristics, current treatment, previous SARS-CoV-2 infection, vaccine characteristics, post-vaccine seizure relapse, other side effect, variation of sleep habits, caffeine, or alcohol intake. Seizure frequency worsening was defined as a ratio between mean monthly frequency post-vaccination and mean monthly frequency pre-vaccination superior to 1. Patients were categorized in two groups: patients with seizure frequency worsening (WORSE) and patients with seizure stability (STABLE).
A total of 358 people participated with a mean age of 47.46 ± 19.04. Focal seizure (79.1%), generalized epilepsy (20.4%), and unknown types of epilepsy (0.5%) were detected among participants. In total, 31 (8.7%) people expressed that they were not willing to receive a COVID-19 vaccine; 302 patients (92.35%) did not experience an increase in the seizure frequency (STABLE-group) whereas 25 patients (7.65%) had a seizure worsening (WORSE-group). Post-vaccine seizures occurred mainly in the 7 days following the administration of the vaccine. Patients in the WORSE-group were treated with a mean higher number of anti-seizure medication (ASMs) (p = 0.003) and had a higher pre-vaccine seizure frequency (p = 0.009) compared with patients in the STABLE-group. Drug-resistant epilepsy was also associated with seizure worsening (p = 0.01). One-year pre-vaccination seizure frequency pattern demonstrated that patients in the WORSE-group had a higher frequency pattern (p < 0.001). Multivariate analysis of the vaccinated group showed that only the seizure frequency pattern (confidence interval [CI] = 1.257-2.028; p < 0.001) was significantly associated with seizure worsening.
In our cohort of vaccinated PwE, only a little percentage had a transient short-term increase of seizure frequency. The present study demonstrates that COVID-19 vaccines have a good safety and tolerability profile in the short term in PwE.
研究 COVID-19 疫苗在癫痫患者(PwE)中的安全性和耐受性。
在这项多中心观察性队列研究中,我们招募了 2021 年 7 月 1 日至 10 月 30 日期间在门诊癫痫诊所就诊的成年癫痫患者(年龄>18 岁)。我们向患者发放了一份关于人口统计学和癫痫特征、当前治疗、既往 SARS-CoV-2 感染、疫苗特征、疫苗接种后癫痫发作复发、其他副作用、睡眠习惯、咖啡因或酒精摄入变化的结构化问卷和访谈。癫痫发作频率恶化定义为疫苗接种后平均每月发作频率与疫苗接种前平均每月发作频率之比大于 1。将患者分为两组:癫痫发作频率恶化(WORSER)组和癫痫发作稳定(STABLE)组。
共有 358 人参与,平均年龄为 47.46±19.04 岁。参与者中检测到局灶性癫痫(79.1%)、全面性癫痫(20.4%)和未知类型的癫痫(0.5%)。共有 31 人(8.7%)表示不愿意接种 COVID-19 疫苗;302 名患者(92.35%)未出现癫痫发作频率增加(STABLE 组),而 25 名患者(7.65%)出现癫痫发作恶化(WORSER 组)。疫苗接种后发作主要发生在接种疫苗后 7 天内。WORSER 组患者接受的抗癫痫药物(ASM)治疗数量中位数更高(p=0.003),且疫苗接种前癫痫发作频率更高(p=0.009)。耐药性癫痫也与癫痫发作恶化相关(p=0.01)。一年前的疫苗接种前癫痫发作频率模式表明,WORSER 组患者的发作频率更高(p<0.001)。接种组的多变量分析显示,只有癫痫发作频率模式(置信区间 [CI]=1.257-2.028;p<0.001)与癫痫发作恶化显著相关。
在我们接种疫苗的 PwE 队列中,只有一小部分患者出现短暂的短期癫痫发作频率增加。本研究表明,COVID-19 疫苗在短期内对 PwE 具有良好的安全性和耐受性。