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药物相关性黄斑水肿:一项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真实世界研究

Drug-related macular edema: a real-world FDA Adverse Event Reporting System database study.

作者信息

Li Xiang, Sun Yi-Qing, Huang Qiong-Lian, Zhang Zhi-Jie, Shi Li-Qiang, Tang Jia-Feng, Luo Zhan-Yang

机构信息

Eye Institute & Affiliated Xiamen Eye Center, School of Medicine, Xiamen University, Xiamen, Fujian, China.

Chongqing Three Gorges Medical College, Wanzhou, 404120, China.

出版信息

BMC Pharmacol Toxicol. 2025 Jan 30;26(1):23. doi: 10.1186/s40360-025-00856-9.

DOI:10.1186/s40360-025-00856-9
PMID:39885611
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11783817/
Abstract

PURPOSE

This study aims to assess the risks associated with drug-induced macular edema and to examine the epidemiological characteristics of this condition.

METHODS

This study analyzed data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database from January 2004 to June 2024 to conduct a disproportionality analysis identifying drugs with positive signals of drug-induced ME. Additionally, the onset time of ME associated with these drugs was examined.

RESULTS

In the FAERS database, a total of 490 drugs were reported to pose a risk of drug-induced ME. Disproportional analysis and screening further identified 8 drugs that significantly increased this risk. Among these, one is ophthalmic drugs, including Latanoprost (ROR = 5.51), and ten are non-ophthalmic drugs, including Cefuroxime (ROR = 75.93), Fingolimod (ROR = 30.69), and Siponimod (ROR = 20.51).

CONCLUSIONS

This study utilizes the FAERS database to investigate potential associations between drug use and the occurrence of ME, rapidly identify drugs that may induce the condition, and propose research strategies. These findings hold significant value for guiding clinical medication practices.

摘要

目的

本研究旨在评估与药物性黄斑水肿相关的风险,并研究这种病症的流行病学特征。

方法

本研究分析了美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库中2004年1月至2024年6月的数据,以进行不成比例分析,确定具有药物性黄斑水肿阳性信号的药物。此外,还研究了与这些药物相关的黄斑水肿的发病时间。

结果

在FAERS数据库中,共有490种药物被报告有导致药物性黄斑水肿的风险。不成比例分析和筛选进一步确定了8种显著增加这种风险的药物。其中,一种是眼科药物,包括拉坦前列素(ROR = 5.51),十种是非眼科药物,包括头孢呋辛(ROR = 75.93)、芬戈莫德(ROR = 30.69)和西波尼莫德(ROR = 20.51)。

结论

本研究利用FAERS数据库调查药物使用与黄斑水肿发生之间的潜在关联,快速识别可能诱发该病的药物,并提出研究策略。这些发现对指导临床用药实践具有重要价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/044d0cfdbc45/40360_2025_856_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/f5f4321ddf47/40360_2025_856_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/e20f9ca31cda/40360_2025_856_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/f35696b689e9/40360_2025_856_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/5374dff6f79f/40360_2025_856_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/3362b733f2c7/40360_2025_856_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/044d0cfdbc45/40360_2025_856_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/f5f4321ddf47/40360_2025_856_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/e20f9ca31cda/40360_2025_856_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/f35696b689e9/40360_2025_856_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/5374dff6f79f/40360_2025_856_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/3362b733f2c7/40360_2025_856_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/467d/11783817/044d0cfdbc45/40360_2025_856_Fig6_HTML.jpg

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