School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
Neuroscience Research Center, Iran University of Medical Sciences, Tehran, Iran.
JAMA Neurol. 2024 Jun 1;81(6):611-618. doi: 10.1001/jamaneurol.2024.0967.
Seizures have been reported as an adverse effect of the SARS-CoV-2 vaccine. However, no study has answered the question of whether there is any association between seizures in the general population and COVID-19 vaccination.
To evaluate the seizure incidence among SARS-CoV-2 vaccine recipients compared with those who received a placebo.
A systematic search of MEDLINE (via PubMed), Web of Science, Scopus, Cochrane Library, Google Scholar, review publications, editorials, letters to editors, and conference papers, along with the references of the included studies from December 2019 to July 7, 2023.
Randomized clinical trials (RCTs) reporting seizure incidence with SARS-CoV-2 vaccination were included.
This study is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework and used the Mantel-Haenszel method with random- and common-effect models. The risk of bias of the studies was assessed using the Cochrane assessment tool for RCTs.
The outcome of interest was new-onset seizure incidence proportion compared among (1) SARS-CoV-2 vaccine recipients and (2) placebo recipients.
Six RCTs were included in the study. Results of the pooled analysis comparing the incidence of new-onset seizure between the 63 521 vaccine and 54 919 placebo recipients in the 28-day follow-up after vaccine/placebo injection showed no statistically significant difference between the 2 groups (9 events [0.014%] in vaccine and 1 event [0.002%] in placebo recipients; odds ratio [OR], 2.70; 95% CI, 0.76-9.57; P = .12; I2 = 0%, τ2 = 0, Cochran Q P = .74). Likewise, in the entire blinded-phase period after injection, with a median of more than 43 days, no significant difference was identified between the vaccine and placebo groups regarding incident new-onset seizure (13/43 724 events [0.03%] in vaccine and 5/40 612 [0.012%] in placebo recipients; OR, 2.31; 95% CI, 0.86-6.23, P = .10, I2 = 0%, τ2 = 0, Cochran Q P = .95).
According to this systematic review and meta-analysis, there was no statistically significant difference in the risk of new-onset seizure incidence between vaccinated individuals and placebo recipients.
已有研究报道，接种 SARS-CoV-2 疫苗后会出现癫痫发作。然而，尚无研究回答普通人群中的癫痫发作与 COVID-19 疫苗接种之间是否存在任何关联。
评估 SARS-CoV-2 疫苗接种者与接种安慰剂者的癫痫发作发生率。
从 2019 年 12 月至 2023 年 7 月 7 日，通过 MEDLINE（通过 PubMed）、Web of Science、Scopus、Cochrane 图书馆、Google Scholar、综述出版物、社论、给编辑的信件和会议论文，对 MEDLINE（通过 PubMed）、Web of Science、Scopus、Cochrane 图书馆、Google Scholar 进行了系统检索，并检索了纳入研究的参考文献。
纳入了报告 SARS-CoV-2 疫苗接种后癫痫发作发生率的随机临床试验 (RCT)。
本研究按照系统评价和荟萃分析的首选报告项目 (PRISMA) 框架进行报告，并使用 Mantel-Haenszel 方法进行随机和共同效应模型分析。使用 Cochrane RCT 评估工具评估了研究的偏倚风险。
主要结局是比较接种 SARS-CoV-2 疫苗者与安慰剂组者之间（1）新出现的癫痫发作发生率。
本研究纳入了 6 项 RCT。在接种疫苗/安慰剂后 28 天的随访中，对 63521 名疫苗和 54919 名安慰剂接种者的新发癫痫发作发生率进行的汇总分析结果显示，两组之间无统计学意义差异（9 例[0.014%]在疫苗组和 1 例[0.002%]在安慰剂组；比值比[OR]，2.70；95%CI，0.76-9.57；P=0.12；I2=0%，τ2=0，Cochran Q P=0.74）。同样，在注射后整个盲法阶段，中位数超过 43 天，疫苗组和安慰剂组新发新发性癫痫发作的发生率无显著差异（疫苗组 43724 例事件中有 13 例[0.03%]，安慰剂组 40612 例中有 5 例[0.012%]；OR，2.31；95%CI，0.86-6.23，P=0.10，I2=0%，τ2=0，Cochran Q P=0.95）。
根据本系统评价和荟萃分析，接种者与安慰剂组者的新发癫痫发作风险无统计学意义差异。
