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药物相关性黄斑变性风险的真实世界药物警戒评估

Real world pharmacovigilance assessment of drug related macular degeneration risks.

作者信息

Chen Xiaodong, Wu Shinan, Wang Shaopan, Yu Chaofeng, Guo Zihan, Huang Shiya, Cai Peixin, Miao Yanliang, Li Shiying, Chen Qian

机构信息

Xiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen University, Xiamen, 361102, Fujian, China.

Department of Ophthalmology, The First Affiliated Hospital of Xiamen University, Xiamen, 361003, Fujian, China.

出版信息

Sci Rep. 2025 Jan 7;15(1):1220. doi: 10.1038/s41598-024-84679-4.

Abstract

Macular degeneration is a leading cause of irreversible vision loss, significantly impacting quality of life. To enhance clinical practice and reduce the risk of drug-related macular degeneration, we analyzed drug-related trends using real-world data. Disproportionality analysis of adverse event reports from the FDA Adverse Event Reporting System (FAERS, 2004-2023) identified 67,683 cases involving 1402 drugs. Among these, 42 drugs were linked to significant risks, including treatments for breast cancer (tamoxifen, raloxifene, anastrozole, letrozole) and diabetes (insulin lispro, insulin human). The BCPNN algorithm revealed that 45.2% (19/42) of these drugs had the strongest associations with macular degeneration, with pentosan polysulfate sodium, travoprost, and tolterodine being the highest-risk drugs. Lifitegrast, nicotine, and travoprost were associated with the shortest onset times for ocular adverse events. Among drug classes, glucocorticosteroids were linked to the most rapid onset of ocular side effects (P < 0.001), typically occurring within two months compared to other drugs. Drug-related macular degeneration was more common in women (70.4%) and predominantly affected those aged 60-80. The incidence of drug-related macular degeneration has steadily increased in recent years. This study offers valuable pharmacovigilance insights, highlighting drugs and demographic factors linked to macular degeneration.

摘要

黄斑变性是不可逆视力丧失的主要原因,对生活质量有重大影响。为了加强临床实践并降低药物相关性黄斑变性的风险,我们使用真实世界数据分析了药物相关趋势。对美国食品药品监督管理局不良事件报告系统(FAERS,2004 - 2023年)的不良事件报告进行不成比例分析,确定了涉及1402种药物的67683例病例。其中,42种药物与重大风险相关,包括乳腺癌治疗药物(他莫昔芬、雷洛昔芬、阿那曲唑、来曲唑)和糖尿病治疗药物(赖脯胰岛素、人胰岛素)。BCPNN算法显示,这些药物中有45.2%(19/42)与黄斑变性的关联最强,戊聚糖多硫酸钠、曲伏前列素和托特罗定是风险最高的药物。lifitegrast、尼古丁和曲伏前列素与眼部不良事件的最短发病时间相关。在药物类别中,糖皮质激素与眼部副作用的发病最快相关(P < 0.001),与其他药物相比,通常在两个月内出现。药物相关性黄斑变性在女性中更常见(70.4%),主要影响60 - 80岁的人群。近年来,药物相关性黄斑变性的发病率稳步上升。本研究提供了有价值的药物警戒见解,突出了与黄斑变性相关的药物和人口统计学因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe33/11707227/7ba19c805d18/41598_2024_84679_Fig1_HTML.jpg

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