Zhang Chunyan, Ren Xiaolei, Huang Jing, Huang Lin, Zhang Xiaohong
Department of Pharmacy, Peking University People's Hospital, Beijing, China.
Expert Opin Drug Saf. 2025 Aug;24(8):977-981. doi: 10.1080/14740338.2024.2387309. Epub 2024 Aug 2.
The objective of this study was to evaluate the reporting associations between Central serous chorioretinopathy (CSCR) and many available drugs using FAERS.
FAERS reports from 2004 to 2023 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify CSCR cases. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs) for the reporting associations between available drugs and CSCR were calculated. A reporting association was considered statistically significant when the lower limit of the 95% CI was > 1.0.
There were 1002 reports of 110 drugs with suspected drug-associated CSCR based on the 'primary suspects' role code in the FAERS database found to have statistically significant signals. Among the top 20 ROR drugs, the most frequently reported drugs were dermatological drugs (ATC:D, 210 cases, 64.41%), followed by antitumor agents and immunological agents (ATC:L,77 cases, 23.62%), Systemic Hormonal Preparations, Excl. Sex hormones and Insulins (ATC:H, 19 cases, 5.80%) and sensory organ drugs (ATC:S, 9 cases, 2.76%). The top 3 drugs associated with CSCR were Prednisolone (144 cases, 44.17%), Fluticasone (29 cases, 8.90%), and Methylprednisolone (27 cases, 8.28%).
This is the first real-world study using FAERS database to investigate drug-induced CSCR. Clinicians and pharmacist must keep in mind CSCR is a serious ocular complication associated with glucocorticoids, tyrosine kinase receptor inhibitor, and other drugs that can cause CSCR.
本研究的目的是使用美国食品药品监督管理局不良事件报告系统（FAERS）评估中心性浆液性脉络膜视网膜病变（CSCR）与多种可用药物之间的报告关联。
研究纳入了2004年至2023年的FAERS报告。使用《医学监管活动医学词典》（MedDRA）识别CSCR病例。计算了可用药物与CSCR之间报告关联的报告比值比（ROR）及相应的95%置信区间（CI）。当95%CI的下限>1.0时，报告关联被认为具有统计学意义。
基于FAERS数据库中“主要怀疑对象”角色代码，有1002份报告涉及110种药物与疑似药物相关的CSCR，发现具有统计学意义的信号。在ROR最高的20种药物中，报告频率最高的药物是皮肤科药物（解剖学治疗学化学分类系统：D，210例，64.41%），其次是抗肿瘤药和免疫制剂（解剖学治疗学化学分类系统：L，77例，23.62%）、全身用激素类制剂（不包括性激素和胰岛素）（解剖学治疗学化学分类系统：H，19例，5.80%）和感觉器官药物（解剖学治疗学化学分类系统：S，9例，2.76%）。与CSCR相关的前3种药物是泼尼松龙（144例，44.17%）、氟替卡松（29例，8.90%）和甲泼尼龙（27例，8.28%）。
这是第一项使用FAERS数据库调查药物性CSCR的真实世界研究。临床医生和药剂师必须牢记，CSCR是一种与糖皮质激素、酪氨酸激酶受体抑制剂及其他可导致CSCR的药物相关的严重眼部并发症。
