Department of Clinical Pharmacy Practice Pedagogy, Tokushima University Graduate School of Biomedical Sciences; Department of Clinical Pharmacology and Therapeutics, Tokushima University Graduate School of Biomedical Sciences, Tokushima University.
Department of Pharmacy, Kochi Medical School Hospital, Kochi.
Pharmazie. 2024 Jun 1;79(6):118-123. doi: 10.1691/ph.2024.4506.
Encephalopathy is the most severe complication of various common infections, including influenza and herpes, and it often results in death or severe neurological disability. The risk factors for viral encephalopathy include non-steroidal anti-inflammatory drug (NSAID) use; however, studies on NSAID-related encephalopathy are limited. In this study, we aimed to investigate the characteristics of NSAID-related encephalopathy. We investigated the incidence of NSAID-related encephalopathy using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases containing reports on spontaneous adverse effects (AEs) published by the Pharmaceuticals and Medical Devices Agency. We used these databases to detect AEs based on reported odds ratios. By separating suspicious drugs, concomitant drugs, and drug interactions involving NSAIDs, we investigated the relationship between encephalopathy pathology and AEs of NSAIDs. Significant encephalopathy signals were detected for loxoprofen and etodolac in the FAERS database and loxoprofen in the JADER database. In the JADER database, significant encephalopathy signals in loxoprofen-treated patients were detected in 70-79-year-old, ≥80-year-old, influenza viral infection, and herpes virus infection groups. Significant encephalopathy signals in patients with herpes virus infection were detected in the ≥80-year-old and loxoprofen-treated groups. Regarding the involvement of loxoprofen in the development of encephalopathy, the JADER database listed loxoprofen as a suspect drug, without indicating any concomitant drug interactions. In conclusion, our findings suggest that loxoprofen and etodolac may be associated with viral encephalopathy. Accordingly, prudence is recommended when using loxoprofen in older individuals with viral infections.
脑病是各种常见感染（包括流感和疱疹）最严重的并发症，常导致死亡或严重神经功能障碍。病毒性脑病的危险因素包括非甾体抗炎药（NSAID）的使用；然而，关于 NSAID 相关性脑病的研究有限。在本研究中，我们旨在研究 NSAID 相关性脑病的特征。我们使用美国食品和药物管理局不良事件报告系统（FAERS）和日本药物不良反应报告（JADER）数据库中的数据调查了 NSAID 相关性脑病的发生率，这些数据库包含了医药和医疗器械局发布的自发不良反应报告。我们使用这些数据库基于报告的比值比来检测不良事件。通过分离可疑药物、伴随药物和涉及 NSAID 的药物相互作用，我们研究了 NSAID 脑病病理与不良事件之间的关系。在 FAERS 数据库中，洛索洛芬和依托度酸被检测出具有显著的脑病信号，在 JADER 数据库中，洛索洛芬也具有显著的脑病信号。在 JADER 数据库中，在年龄 70-79 岁、≥80 岁、流感病毒感染和疱疹病毒感染的洛索洛芬治疗患者中检测到显著的脑病信号。在≥80 岁和洛索洛芬治疗的疱疹病毒感染患者中也检测到显著的脑病信号。关于洛索洛芬在脑病发展中的作用，JADER 数据库将洛索洛芬列为可疑药物，但未指出任何伴随药物相互作用。总之，我们的研究结果表明，洛索洛芬和依托度酸可能与病毒性脑病有关。因此，建议在老年人因病毒感染而使用洛索洛芬时应谨慎。
