Zou Fan, Cui Zhiwei, Lou Siyu, Ou Yingyong, Zhu Chengyu, Shu Chengjie, Chen Junyou, Zhao Ruizhen, Wu Zhu, Wang Li, Chen Zhenyong, Chen Huayu, Lan Yuanbo
Department of Tuberculosis, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China.
Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Front Pharmacol. 2024 Feb 16;15:1338902. doi: 10.3389/fphar.2024.1338902. eCollection 2024.
Linezolid is an oxazolidinone antibiotic that is active against drug-resistant Gram-positive bacteria and multidrug-resistant . Real-world studies on the safety of linezolid in large populations are lacking. This study aimed to determine the adverse events associated with linezolid in real-world settings by analyzing data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). We retrospectively extracted reports on adverse drug events (ADEs) from the FAERS database from the first quarter of 2004 to that of 2023. By using disproportionality analysis including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), along with the multi-item gamma Poisson shrinker (MGPS), we evaluated whether there was a significant association between linezolid and ADE. The time to onset of ADE was further analyzed in the general population and within each age, weight, reporting population, and weight subgroups. A total of 11,176 reports of linezolid as the "primary suspected" drug and 263 significant adverse events of linezolid were identified, including some common adverse events such as thrombocytopenia ( = 1,139, ROR 21.98), anaemia ( = 704, ROR 7.39), and unexpected signals that were not listed on the drug label such as rhabdomyolysis ( = 90, ROR 4.33), and electrocardiogram QT prolonged ( = 73, ROR 4.07). Linezolid-induced adverse reactions involved 27 System Organ Class (SOC). Gender differences existed in ADE signals related to linezolid. The median onset time of all ADEs was 6 days, and most ADEs ( = 3,778) occurred within the first month of linezolid use but some may continue to occur even after a year of treatment ( = 46). This study reports the time to onset of adverse effects in detail at the levels of SOC and specific preferred term (PT). The results of our study provide valuable insights for optimizing the use of linezolid and reducing potential side effects, expected to facilitate the safe use of linezolid in clinical settings.
利奈唑胺是一种恶唑烷酮类抗生素，对耐药革兰氏阳性菌和多重耐药菌有效。目前缺乏关于利奈唑胺在大量人群中安全性的真实世界研究。本研究旨在通过分析美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）的数据，确定利奈唑胺在真实世界环境中相关的不良事件。我们回顾性地从FAERS数据库中提取了2004年第一季度至2023年第一季度的药物不良事件（ADE）报告。通过使用包括报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）以及多项目伽马泊松收缩器（MGPS）在内的不成比例分析，我们评估了利奈唑胺与ADE之间是否存在显著关联。在总体人群以及各年龄、体重、报告人群和体重亚组中进一步分析了ADE的发病时间。共确定了11176份将利奈唑胺列为“主要疑似”药物的报告以及263例利奈唑胺的严重不良事件，包括一些常见不良事件，如血小板减少（n = 1139，ROR 21.98）、贫血（n = 704，ROR 7.39），以及药物标签上未列出的意外信号，如横纹肌溶解（n = 90，ROR 4.33）和心电图QT间期延长（n = 73，ROR 4.07）。利奈唑胺引起的不良反应涉及27个系统器官分类（SOC）。与利奈唑胺相关的ADE信号存在性别差异。所有ADE的中位发病时间为6天，大多数ADE（n = 3778）发生在使用利奈唑胺的第一个月内，但有些甚至在治疗一年后仍可能继续发生（n = 46）。本研究详细报告了在SOC和特定首选术语（PT）水平上不良反应的发病时间。我们的研究结果为优化利奈唑胺的使用和减少潜在副作用提供了有价值的见解，有望促进利奈唑胺在临床环境中的安全使用。
