Zhu Hao, Guo Jack, Lui Hannah, Ip Patrick
Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong Kong, China,
Department of Health and Kinesiology, University of Illinois at Urbana-Champaign, Urbana, Illinois, USA.
Neuropsychobiology. 2025 May 30:1-9. doi: 10.1159/000546602.
Although lithium has long been considered the gold standard for mood stabilization in the treatment of bipolar disorder, growing concerns about its adverse events have significantly undermined its once-trusted status. This study aims to conduct a pharmacovigilance analysis of lithium to provide a more comprehensive understanding of its safety profile.
Four disproportionality analysis methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM), were employed to detect potential signals between lithium and various adverse events.
Analysis of 6,909 adverse event reports from the FDA Adverse Event Reporting System (FAERS) showed that lithium-related adverse events occur in the endocrine, renal or urinary, nervous, and psychiatric systems. Well-known adverse events, such as hypothyroidism, nephrogenic diabetes insipidus, and ataxia, were found. In addition, several previously overlooked adverse events, such as renal oncocytoma, benign parathyroid tumor, and Adams-Stokes syndrome, were identified.
By analyzing real-world data, this study provides a comprehensive evaluation of lithium's safety profile, offering critical evidence for its clinical risk. However, given the inherent limitations of FAERS, such as underreporting of minor symptoms, the findings should be interpreted cautiously.
尽管长期以来锂盐一直被视为治疗双相情感障碍时情绪稳定的金标准，但对其不良事件的日益担忧已严重损害了它曾经备受信任的地位。本研究旨在对锂盐进行药物警戒分析，以更全面地了解其安全性概况。
采用四种不成比例分析方法，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）和经验贝叶斯几何均值（EBGM），来检测锂盐与各种不良事件之间的潜在信号。
对美国食品药品监督管理局不良事件报告系统（FAERS）的6909份不良事件报告进行分析后发现，与锂盐相关的不良事件发生在内分泌、肾脏或泌尿系统、神经和精神系统。发现了一些众所周知的不良事件，如甲状腺功能减退、肾性尿崩症和共济失调。此外，还识别出了一些先前被忽视的不良事件，如肾嗜酸细胞瘤、甲状旁腺良性肿瘤和阿-斯综合征。
通过分析真实世界的数据，本研究对锂盐的安全性概况进行了全面评估，为其临床风险提供了关键证据。然而，鉴于FAERS存在诸如轻微症状报告不足等固有局限性，应对研究结果谨慎解读。
