新型 2019 冠状病毒病（COVID-19）疫苗在癫痫患者（PwE）中的安全性和耐受性：一项横断面研究。

Safety and tolerability of the novel 2019 coronavirus disease (COVID-19) vaccines among people with epilepsy (PwE): A cross-sectional study.

机构信息

Department of Neurology, Ibn Sina Hospital, Sabah Medical Area, Kuwait.

Department of Neurology, Ibn Sina Hospital, Sabah Medical Area, Kuwait; Department of Neuropsychiatry, Minia University, Egypt.

出版信息

Seizure. 2021 Nov;92:2-9. doi: 10.1016/j.seizure.2021.08.001. Epub 2021 Aug 6.

DOI:10.1016/j.seizure.2021.08.001

PMID:34391030

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8343389/

Abstract

BACKGROUND

People with epilepsy (PwE) were concerned about the safety of the novel 2019 Coronavirus Disease (COVID-19) vaccines.

OBJECTIVE

This study aimed to assess the side effects experienced by PwE following vaccination with COVID-19 vaccines and to identify the causes of vaccine hesitation.

METHODS

We administered a questionnaire to PwE, who visited the epilepsy clinic at Ibn Sina Hospital in Kuwait during the first two working weeks of April 2021. It included socio-demographic, epilepsy status, and vaccination data. In addition, we asked those who were not vaccinated yet about the reasons and their plan.

RESULTS

A total of 111 PwE were surveyed, with 82 being vaccinated and 29 being unvaccinated. Out of the 82 vaccinated, 66 (80.5%) reported at least one side effect. Patients who received the Pfizer BioNTech mRNA vaccine (BNT162b2) (first, second dosage); and the Oxford-AstraZenecaa chimpanzee adenovirus-vectored vaccine (ChAdOx1nCoV-19) (first dose) had the following reactions: Pain at the injection site (40%, 67.6%), 43.8%, fatigue (47%, 32.4%), 46.9%, Headache (33.3%, 35.3%), 34.4% and Myalgia (40%, 35%), 50% respectively. Local site effects, including pain (67.6% vs. 40%, p = < 0.001) and redness (26.5% vs 6.7%, p = 0.019), were more statistically significantly after the second dose of BNT162b2 vaccine compared to the first dose of the same vaccine. While there was no significant difference in systemic side effects frequencies between the two doses of the BNT162b2 vaccine. The systemic side effects were more statistically significantly after the first dose of ChAdOx1nCoV-19 compared to the first dose of the BNT162b2 vaccine and those included fever (56.3% vs 13.3%, p = < 0.001), chills (37.5% vs 6.7%, p = < 0.001), myalgia (50% vs 40%, p = < 0.001) and arthralgia (25% vs 6.7%, p = 0.021). The local site reactions were not significantly different between the first doses of both vaccines. Among the subgroup who had vaccine-related side effects, 66.7% were females, 90.9% were 55 or younger, 63.6% were on polytherapy, 74% had side effects for one day or less, and 95% were symptoms free by the end of the first-week post-vaccination. Symptoms were mild in 68% of the patients and moderate in 29.3%. Most patients (93.9%) did not report seizure worsening after vaccination. The relative risk of seizure worsening after the first and second doses of BNT162b2 and the first dose of ChAdOx1nCoV-19 vaccines was 1.027 (95% CI 0.891-1.183), 1.019 (95% CI 0.928-1.119), and 1.026 (95% CI 0.929-1.134) respectively. After the first dose of BNT162b2, one patient reported the development of status epilepticus. Among the non-vaccinated group, 34.9% were still indecisive, while 37.9% rejected the vaccination. Fear of adverse effects (42.9%) and fear of epilepsy worsening (23.8%) were the main reasons for vaccine hesitation.

CONCLUSIONS

This study shows that the two vaccines under consideration (BNT162b2 and ChAdOx1nCoV-19) have a good safety profile and a low risk of epilepsy worsening among a cohort of PwE in Kuwait.

摘要

背景

癫痫患者（PwE）对新型 2019 冠状病毒病（COVID-19）疫苗的安全性感到担忧。

目的

本研究旨在评估 PwE 接种 COVID-19 疫苗后的副作用，并确定疫苗犹豫的原因。

方法

我们向在科威特 Ibn Sina 医院癫痫诊所就诊的 PwE 发放了一份问卷，调查时间为 2021 年 4 月的前两周的两个工作日。问卷包括社会人口统计学、癫痫状况和疫苗接种数据。此外，我们还询问了那些尚未接种疫苗的人未接种疫苗的原因及其计划。

结果

共有 111 名 PwE 接受了调查，其中 82 人已接种，29 人未接种。在已接种的 82 人中，66 人（80.5%）报告至少有一种副作用。接种辉瑞 BioNTech mRNA 疫苗（BNT162b2）（第一、第二剂）和牛津-阿斯利康 chimpanzee 腺病毒载体疫苗（ChAdOx1nCoV-19）（第一剂）的患者出现以下反应：注射部位疼痛（40%，67.6%）、乏力（47%，32.4%）、头痛（33.3%，35.3%）和肌痛（46.9%，35%）。局部反应包括疼痛（67.6% vs. 40%，p<0.001）和发红（26.5% vs. 6.7%，p=0.019），第二剂 BNT162b2 疫苗比第一剂更明显。而两剂 BNT162b2 疫苗的全身副作用频率无显著差异。ChAdOx1nCoV-19 疫苗的第一剂比 BNT162b2 疫苗的第一剂更明显地引起全身副作用，包括发热（56.3% vs. 13.3%，p<0.001）、寒战（37.5% vs. 6.7%，p<0.001）、肌痛（50% vs. 40%，p<0.001）和关节痛（25% vs. 6.7%，p=0.021）。两剂疫苗的第一剂的局部反应无显著差异。在有疫苗相关副作用的亚组中，66.7%为女性，90.9%为 55 岁或以下，63.6%为多药治疗，74%的副作用持续一天或更短时间，95%的症状在接种疫苗后第一周结束时消失。症状在 68%的患者中为轻度，在 29.3%的患者中为中度。大多数患者（93.9%）在接种疫苗后没有癫痫恶化。接种 BNT162b2 疫苗第一剂和第二剂和 ChAdOx1nCoV-19 疫苗第一剂后癫痫恶化的相对风险分别为 1.027（95%CI 0.891-1.183）、1.019（95%CI 0.928-1.119）和 1.026（95%CI 0.929-1.134）。在接种 BNT162b2 疫苗第一剂后，有 1 名患者出现癫痫持续状态。在未接种疫苗的组中，34.9%的人仍犹豫不决，37.9%的人拒绝接种疫苗。对不良反应的恐惧（42.9%）和对癫痫恶化的恐惧（23.8%）是疫苗犹豫的主要原因。