Hyesung Lee, Bin Hong, Eun Lee, Jin Young Park, Jaehun Jung, Woo Jung Kim, Ju-Young Shin
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引用次数: 0
摘要
背景：迄今为止，在有充分研究设计的大量人群中，关于COVID-19疫苗接种后精神不良事件潜在风险的证据知之甚少。目的：探讨COVID-19疫苗接种是否与精神不良事件风险增加相关。方法：利用韩国联动数据库获取2019 - 2021年的登记数据和理赔数据，开展基于人群的自我对照病例系列研究，共纳入11 751 806人。主要结局包括在COVID-19疫苗接种后21天内的焦虑/紧张、情绪障碍、知觉障碍/精神病、攻击/行为障碍、认知障碍和睡眠障碍。次要结局是根据每个人的精神病史分层的主要结局。使用条件泊松回归估计发病率比（IRR）和95%置信区间。结果：COVID-19疫苗接种并未增加焦虑和紧张（调整IRR 0.95, 95% CI 0.95-0.96）、情绪障碍（调整IRR 0.75, 95% CI 0.75-0.76）、知觉障碍和精神病（调整IRR 0.72, 95% CI 0.70-0.74）、攻击和行为障碍（调整IRR 0.93, 95% CI 0.89-0.97）、认知障碍（调整IRR 0.68, 95% CI 0.67-0.69）或睡眠障碍（调整IRR 0.90, 95% CI 0.89-0.91）的发生率。次要结局与主要结局一致，尽管焦虑和紧张（调整后的IRR为1.17,95% CI为1.15-1.18）和睡眠障碍（调整后的IRR为1.07,95% CI为1.06-1.09）在没有精神疾病史的个体中具有统计学意义。敏感性分析结果与我们的主要发现一致。结论：我们的研究结果提供了COVID-19疫苗在精神不良事件方面的短期安全性概况。无论是否有精神合并症史，都需要在COVID-19疫苗接种后持续监测焦虑/神经或睡眠障碍。
Short-term risk of psychiatric adverse events following COVID-19 vaccination: nationwide self-controlled case series study.
Background: To date, little is known about the evidence of a potential risk of psychiatric adverse events following COVID-19 vaccination in large populations with adequate study design.
Aims: To investigate whether COVID-19 vaccination is associated with increased risk of psychiatric adverse events.
Method: We used South Korea's linkage database to obtain registry data and claims data from 2019 to 2021, and conducted a population-based self-controlled case series study including 11 751 806 individuals. Primary outcomes included anxiety/nervousness, mood disorders, perceptual disturbances/psychoses, aggression/behavioural disturbances, cognitive impairments and sleep disorders within 21 days of COVID-19 vaccination. Secondary outcomes were the stratified primary outcomes according to each individual's psychiatric history. Conditional Poisson regression was used to estimate incidence rate ratios (IRR) and 95% confidence intervals.
Results: COVID-19 vaccination did not increase the rate of anxiety and nervousness (adjusted IRR 0.95, 95% CI 0.95-0.96), mood disorders (adjusted IRR 0.75, 95% CI 0.75-0.76), perceptual disturbances and psychoses (adjusted IRR 0.72, 95% CI 0.70-0.74), aggression and behavioural disturbances (adjusted IRR 0.93, 95% CI 0.89-0.97), cognitive impairment (adjusted IRR 0.68, 95% CI 0.67-0.69) or sleep disorders (adjusted IRR 0.90, 95% CI 0.89-0.91). Secondary outcomes were consistent with the primary outcome, although the adjusted IRRs for anxiety and nervousness (adjusted IRR 1.17, 95% CI 1.15-1.18) and sleep disorders (adjusted IRR 1.07, 95% CI 1.06-1.09) were statistically significant in individuals with no history of psychiatric disorders. Sensitivity analyses showed consistent results with our main findings.
Conclusions: Our findings provide short-term safety profiles for COVID-19 vaccines regarding psychiatric adverse events. Continuous monitoring of anxiety/nervousness or sleep disorders after COVID-19 vaccination is required regardless of history of psychiatric comorbidities.
期刊介绍：
Announcing the launch of BJPsych Open, an exciting new open access online journal for the publication of all methodologically sound research in all fields of psychiatry and disciplines related to mental health. BJPsych Open will maintain the highest scientific, peer review, and ethical standards of the BJPsych, ensure rapid publication for authors whilst sharing research with no cost to the reader in the spirit of maximising dissemination and public engagement. Cascade submission from BJPsych to BJPsych Open is a new option for authors whose first priority is rapid online publication with the prestigious BJPsych brand. Authors will also retain copyright to their works under a creative commons license.
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