ImportanceSeizures 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.ObjectiveTo evaluate the seizure incidence among SARS-CoV-2 vaccine recipients compared with those who received a placebo.Data SourcesA 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.Study SelectionRandomized clinical trials (RCTs) reporting seizure incidence with SARS-CoV-2 vaccination were included.Data Extraction and SynthesisThis 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.Main Outcomes and MeasuresThe outcome of interest was new-onset seizure incidence proportion compared among (1) SARS-CoV-2 vaccine recipients and (2) placebo recipients.ResultsSix 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, 0.86-3.23, P > .99, I2 = 0%, τ2 = 0, Cochran Q P = .95).Conclusions and RelevanceAccording 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.

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新发癫痫发作与 SARS-CoV-2 疫苗的关联

据报道，癫痫发作是 SARS-CoV-2 疫苗的不良反应。然而，尚无研究回答一般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的问题。目的评估 SARS-CoV-2 疫苗接种者与接受安慰剂的人相比，癫痫发作的发生率。数据来源系统性的检索 MEDLINE（通过 PubMed）、Web of Science、Scopus、Cochrane 图书馆、Google Scholar、综述出版物、社论、给编辑的信和会议论文，以及 2019 年 12 月至 2023 年 7 月 7 日纳入研究的参考文献。研究选择包括报告 SARS-CoV-2 疫苗接种后癫痫发作发生率的随机临床试验 (RCT)。数据提取和合成本研究根据系统评价和荟萃分析框架的首选报告项目进行报告，并使用 Mantel-Haenszel 方法随机- 和共同效应模型。使用 Cochrane 随机对照试验评估工具评估研究的偏倚风险。 主要结果和措施 感兴趣的结果是 (1) SARS-CoV-2 疫苗接受者和 (2) 安慰剂接受者之间新发癫痫发作比例的比较。结果该研究纳入了六项随机对照试验。在疫苗/安慰剂注射后 28 天的随访中，对 63 521 名疫苗接种者和 54 919 名安慰剂接受者之间的新发癫痫发作发生率进行了汇总分析，结果显示两组之间没有统计学上的显着差异（9 个事件 [0.014 %] 在疫苗和安慰剂接受者中 [0.002%]；比值比 [OR]，2.70；95% CI，0.76-9.57；磷= .12；我2= 0%，τ2 = 0，科克伦QP= .74）。同样，在注射后的整个盲期（中位数超过 43 天）中，疫苗组和安慰剂组之间在新发癫痫发作事件方面没有发现显着差异（疫苗组中的 13/43 724 事件 [0.03%]）安慰剂接受者为 5/40 612 [0.012%]；OR，2.31；95% CI，0.86-3.23，磷> .99,我2= 0%，τ2 = 0，科克伦QP= .95）。结论和相关性根据这项系统评价和荟萃分析，接种疫苗的个体和安慰剂接受者之间新发癫痫发作的风险没有统计学上的显着差异。