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基于美国食品药品监督管理局不良事件报告系统数据库的利奈唑胺相关神经系统不良药物反应的风险评估
Authors Yin J, Chen X, Sun J, Wang Y, Wang K
Received 21 November 2024
Accepted for publication 2 April 2025
Published 28 May 2025 Volume 2025:18 Pages 2969—2981
DOI http://doi.org/10.2147/JMDH.S507827
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
Jingwen Yin,1 Xi Chen,2 Jingjing Sun,2 Yu Wang,1 Kunkun Wang2
1Department of Pharmacy, Tianjin 4th Center Hospital, Tianjin, People’s Republic of China; 2Department of Critical Care Medicine, Tianjin 4th Center Hospital, Tianjin, People’s Republic of China
Correspondence: Kunkun Wang, Department of Critical Care Medicine, Tianjin 4th Center Hospital, No. 1, Zhongshan Road, Hebei District, Tianjin, 300142, People’s Republic of China, Tel +86 022 26249292, Email wangkun_kun24@126.com
Objective: To conduct data mining and analysis on neurological adverse drug reactions (ADRs), defined as any unwanted neurological effects caused by the use of linezolid, affecting both the central and peripheral nervous systems. This study also aims to investigate potential drug–drug interactions that may increase the risk of these ADRs when linezolid is used in combination with other medications. The findings aim to provide guidance for the safe clinical use of linezolid.
Methods: Data from the US Food and Drug Administration Adverse Event Reporting System between 1 July 2014 and 30 June 2024 were analysed to identify linezolid-related neurological ADRs. The Ω shrinkage measure was used to detect drugs associated with an elevated risk of neurological ADRs.
Results: A total of 8521 reports of linezolid-related ADRs were retrieved, of which 20.12% (1720 cases) involved neurological ADRs. Forty-five signals of neurological ADRs were detected, with serotonin syndrome (436 cases, reporting odds ratio [ROR] = 43.66, representing 25.35%) and peripheral neuropathy (413 cases, ROR = 7.88, representing 24.01%) being the most prevalent. Additionally, 23 previously undocumented ADR signals and 21 drugs associated with an increased risk of neurological ADRs (Ω 025 > 0) were identified.
Conclusion: This study highlights the need for careful monitoring of neurological ADRs associated with linezolid, vigilance regarding previously undocumented ADRs and the prudent management of concomitant medications. These findings provide essential guidance for the safe clinical use of linezolid.
Keywords: linezolid, signal detection, neurotoxicity, adverse drug reaction