2021年至2023年新冠疫苗最常见的五种神经系统影响的不成比例分析：来自欧洲药品管理局药物警戒系统（EudraVigilance）的见解
Disproportionality Analysis of the Five Most Widespread Neurological Effects of COVID-19 Vaccines from 2021 to 2023: Insights from EudraVigilance.
作者信息
López de Las Huertas Arturo Gómez, Stewart Stefan, Elizalde Mikel Urroz, Guijarro-Eguinoa Javier, Seco-Meseguer Enrique, Diago-Sempere Elena, González María Jiménez, Carcas-Sansuan Antonio J, Pérez Alberto M Borobia, Ramírez Elena
机构信息
Clinical Pharmacology Department, La Paz University Hospital-IdiPAZ, School of Medicine, Autonomous University of Madrid, 28046 Madrid, Spain.
Clinical Trials Unit, La Paz University Hospital-IdiPAZ, 28046 Madrid, Spain.
出版信息
Pharmaceuticals (Basel). 2025 Apr 27;18(5):636. doi: 10.3390/ph18050636.
Post-market surveillance of COVID-19 vaccines is vital. This study analyzed EudraVigilance data (Jan 2021-Dec 2023) to detect potential safety signals linking COVID-19 vaccines and specific neurological adverse events (aseptic meningitis, Guillain-Barré syndrome, polyradiculoneuropathies, multiple sclerosis, transverse myelitis, neuromyelitis optica). It also explored the impact of non-healthcare professional reports on disproportionality analysis. EudraVigilance reports were analyzed to quantify neurological events for 5 COVID-19 vaccines and 47 comparators. Disproportionality was assessed using the Proportional Reporting Ratio (PRR). Spearman's correlation (SCC) was used to examine the impact of non-healthcare professional reports on PRR. An analysis of 4,159,820 COVID-19 vaccine and 114,025 comparator reports showed a reporting decline over time. A higher proportion of adverse drug event reports were submitted by non-healthcare professionals for COVID-19 vaccines compared to control vaccines, a trend observed consistently across 2021 (57.3% vs. 33%, < 0.001), 2022 (59.4% vs. 36.5%, = 0.001), and 2023 (42% vs. 24.36%, = 0.006). In 2023, significant signals (PRR ≥ 2) were found between Jcovden© and polyradiculoneuropathy (PRR 5.4, IC 95% 3.98-7.32), multiple sclerosis (PRR 2.72, IC 95% (1.08-6.87), transverse myelitis (PRR 4.68, IC 95% 1.02-21.35) and neuromyelitis optica (PRR 7.79, IC 95% 3.5-17.37). In addition, both Spikevax© and Comirnaty© showed significant signals with multiple sclerosis (PRR 2.50, IC 95% 1.70-3.68, and PRR 2.33, IC 95% 1.68-3.24) and transverse myelitis (PRR 3.50, IC 95% 1.66-7.50 and PRR 3.58, IC 95% 1.85-6.93). A significant negative correlation between the proportion of reports from non-healthcare professionals and the case/no-case ratio was found (SCC = -0.4683, = 0.009). While some significant signals emerged in 2023, the combined three-year data showed no vaccine exceeding the PRR threshold of 2. High-quality data and bias mitigation strategies are crucial for accurate PRR estimation in pharmacovigilance and public health.
新型冠状病毒肺炎（COVID-19）疫苗的上市后监测至关重要。本研究分析了欧洲药品管理局药物警戒数据库（EudraVigilance）的数据（2021年1月至2023年12月），以检测新型冠状病毒肺炎疫苗与特定神经系统不良事件（无菌性脑膜炎、吉兰-巴雷综合征、多发性神经根神经病、多发性硬化症、横贯性脊髓炎、视神经脊髓炎）之间的潜在安全信号。研究还探讨了非医疗保健专业人员报告对不成比例分析的影响。对EudraVigilance报告进行分析，以量化5种新型冠状病毒肺炎疫苗和47种对照疫苗的神经系统事件。使用比例报告率（PRR）评估不成比例性。采用斯皮尔曼相关性（SCC）分析非医疗保健专业人员报告对PRR的影响。对4159820份新型冠状病毒肺炎疫苗报告和114025份对照疫苗报告进行分析，结果显示报告数量随时间呈下降趋势。与对照疫苗相比，新型冠状病毒肺炎疫苗的不良药物事件报告中，非医疗保健专业人员提交的比例更高，这一趋势在2021年（57.3%对33%，P<0.001）、2022年（59.4%对36.5%，P = 0.001）和2023年（42%对24.36%，P = 0.006）均持续存在。2023年，在Jcovden©与多发性神经根神经病（PRR 5.4，95%置信区间3.98 - 7.32）、多发性硬化症（PRR 2.72，95%置信区间（1.08 - 6.87）、横贯性脊髓炎（PRR 4.68，95%置信区间1.02 - 21.35）和视神经脊髓炎（PRR 7.79，95%置信区间3.5 - 17.37）之间发现了显著信号。此外，Spikevax©和Comirnaty©在多发性硬化症（PRR 2.50，95%置信区间1.70 - 3.68，以及PRR 2.33，95%置信区间1.68 - 3.24）和横贯性脊髓炎（PRR 3.50，95%置信区间1.66 - 7.50和PRR 3.58，95%置信区间（1.85 - 6.93）方面均显示出显著信号。发现非医疗保健专业人员报告的比例与病例/非病例比率之间存在显著负相关（SCC = -0.4683，P = 0.009）。虽然2023年出现了一些显著信号，但三年综合数据显示没有疫苗超过PRR阈值2。高质量数据和偏差缓解策略对于药物警戒和公共卫生中准确的PRR估计至关重要。
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