Xiao Kunhong, Chen Xiaodong, Wu Shinan, Zhang Yiyan, Chen Ruiye, Wu Haixing, Qi Ziyi, Liu Jiahao, Wang Yuru, Miao Yanliang, Huang Yan, Li Li
Department of Ophthalmology and Optometry, Fujian Medical University, Fuzhou, China.
Department of Ophthalmology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China.
Ther Adv Drug Saf. 2025 Sep 22;16:20420986251371983. doi: 10.1177/20420986251371983. eCollection 2025.
Blepharoptosis is one of the most common eyelid disorders in clinical ophthalmology. Previous evidence on drug-related blepharoptosis limited to case reports.
This study aims to systematically evaluate the disproportionality signals of drugs associated with blepharoptosis using large-scale real-world data from the US FDA Adverse Event Reporting System (FAERS).
A retrospective disproportionality analysis was conducted based on the FAERS database.
A total of 21,838,627 reports from the FAERS database, spanning 2004 to 2024, were included, with 19,541,994 reports retained after deduplication. Disproportionality analysis methods including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker were employed to detect positive signals. The therapeutic purposes of the drugs, drug-related reporting patterns, drug signals strength, and onset times of adverse reactions were comprehensively assessed.
A total of 9324 cases of blepharoptosis were confirmed, involving 20 identified with significant signals. They primarily include antineoplastic and immunomodulating agents, sensory organ drugs, and neuropsychiatric drugs. Eleven drugs had previously been reported to be associated with blepharoptosis, while 9 were newly identified. Botulinum toxin A, ravulizumab, and latanoprost were found to exhibit the strongest signals. Neuropsychiatric drugs (e.g., lidocaine) had a median onset time of 1-9 days, while antineoplastic and immunomodulating agents (e.g., ravulizumab) had a median onset time of 164-912 days. Avelumab and rosuvastatin showed stronger signals for elderly males, while botulinum toxin A and bupivacaine were more significant for younger females.
This study validates known associations such as immune checkpoint inhibitors and neuroregulatory agents, and identifies drug-related signals. There are significant differences in the onset times of adverse reactions across drug categories, suggesting the need for targeted monitoring.
睑下垂是临床眼科最常见的眼睑疾病之一。先前关于药物相关性睑下垂的证据仅限于病例报告。
本研究旨在利用美国食品药品监督管理局不良事件报告系统（FAERS）的大规模真实世界数据，系统评估与睑下垂相关药物的不成比例信号。
基于FAERS数据库进行回顾性不成比例分析。
纳入FAERS数据库2004年至2024年的总计21838627份报告，去重后保留19541994份报告。采用报告比值比、比例报告比、贝叶斯置信传播神经网络和多项伽马泊松收缩器等不成比例分析方法检测阳性信号。全面评估药物的治疗目的、药物相关报告模式、药物信号强度和不良反应的发病时间。
共确认9324例睑下垂病例，涉及20种有显著信号的药物。它们主要包括抗肿瘤和免疫调节药物、感觉器官药物和神经精神药物。11种药物先前已被报道与睑下垂有关，而9种是新发现的。发现A型肉毒毒素、ravulizumab和拉坦前列素表现出最强的信号。神经精神药物（如利多卡因）的中位发病时间为1 - 9天，而抗肿瘤和免疫调节药物（如ravulizumab）的中位发病时间为164 - 912天。阿维鲁单抗和瑞舒伐他汀在老年男性中显示出更强的信号，而A型肉毒毒素和布比卡因在年轻女性中更显著。
本研究验证了免疫检查点抑制剂和神经调节药物等已知关联，并识别出药物相关信号。不同药物类别不良反应的发病时间存在显著差异，提示需要进行针对性监测。
