General Affairs Team, Marumori-machi National Health Insurance Marumori Hospital, Miyagi, Japan;, Email:
Laboratory of Drug informatics, Gifu Pharmaceutical University, Gifu, Japan.
Pharmazie. 2022 Sep 1;77(7):262-269. doi: 10.1691/ph.2022.2354.
Acute disseminated encephalomyelitis (ADEM) is a rare and immune-mediated inflammatory disorder of the central nervous system (CNS) that can be triggered by infections and vaccinations. To date, only anecdotal case studies have reported the association between ADEM incidence and seasonal influenza vaccines, and multiple studies have found no association. This study aimed to investigate the association between the incidence of ADEM and seasonal influenza vaccines in a real-world setting using data from the United States Vaccine Adverse Event Reporting System (VAERS). Further, propensity score matching and disproportionality analysis was performed by calculating the adjusted reporting odds ratio (ROR) of reported ADEM cases associated with seasonal influenza vaccines using multiple logistic regression. Additionally, we analysed the time-to-onset using Weibull shape parameters (WSPs). The VAERS database contained 390,352 adverse events reported from January 2011 to December 2020. The ROR of seasonal influenza vaccines for ADEM was 3.02 (95% confidence interval: 1.72-5.33). The median duration (interquartile range) of ADEM was 11.0 (5.0-33.0) days. The median duration of ADEM induced by egg culture-based influenza vaccine (Egg-based vaccine) and cell culture-based influenza vaccine (Cell-based vaccine) was 10.0 (5.0-24.0) and 91.0 (79.0-125.0) days ( < 0.001), respectively. Only Cell-based cases had WSP β > 1, indicating a wear-out failure type. The incidence of ADEM within 30 days after administration of egg- and Cell-based vaccines was 78.6% and 0.0%, respectively. Our findings indicate that ADEM incidence is associated with seasonal influenza vaccines; thus, careful monitoring of ADEM is required within the first month of Egg-based vaccination and after two months of Cell-based vaccination. Neurologists and general practitioners should exercise caution, as the timing for careful monitoring varies depending on the vaccine type.
急性播散性脑脊髓炎（ADEM）是一种罕见的中枢神经系统（CNS）免疫介导的炎症性疾病，可由感染和疫苗接种引发。迄今为止，仅有一些病例研究报告了 ADEM 发病率与季节性流感疫苗之间的关联，而多项研究并未发现关联。本研究旨在使用美国疫苗不良事件报告系统（VAERS）的数据，在真实环境中调查 ADEM 发病率与季节性流感疫苗之间的关联。此外，还通过使用多项逻辑回归计算与季节性流感疫苗相关的 ADEM 报告病例的调整报告比值比（ROR），进行倾向评分匹配和不均衡分析。此外，我们还使用 Weibull 形状参数（WSP）分析了发病时间。VAERS 数据库包含 2011 年 1 月至 2020 年 12 月期间报告的 390352 例不良事件。季节性流感疫苗引起 ADEM 的 ROR 为 3.02（95%置信区间：1.72-5.33）。ADEM 的中位持续时间（四分位间距）为 11.0（5.0-33.0）天。基于鸡蛋培养的流感疫苗（Egg-based 疫苗）和基于细胞培养的流感疫苗（Cell-based 疫苗）引起的 ADEM 的中位持续时间分别为 10.0（5.0-24.0）和 91.0（79.0-125.0）天（<0.001）。只有 Cell-based 病例的 WSPβ>1，表明存在疲劳失效类型。Egg-based 和 Cell-based 疫苗接种后 30 天内发生 ADEM 的发生率分别为 78.6%和 0.0%。我们的研究结果表明，ADEM 的发病率与季节性流感疫苗相关；因此，需要在 Egg-based 疫苗接种后第一个月和 Cell-based 疫苗接种后两个月内密切监测 ADEM。神经科医生和全科医生应保持警惕，因为仔细监测的时间取决于疫苗类型。
