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药物性光敏反应的病因:使用美国食品药品监督管理局不良事件报告系统数据库进行的分析

Causes of drug-induced photosensitivity: an analysis using FDA adverse event reporting system database.

作者信息

Ge Lele, Huang Xianghua, Dong Zhu, Zhong Tao

机构信息

Department of Pharmacy, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.

Hangzhou Yi Yao Information Technology Co., Ltd., Hangzhou, Zhejiang, China.

出版信息

Sci Rep. 2025 May 24;15(1):18102. doi: 10.1038/s41598-025-03114-4.

Abstract

The purpose of this study is to analyze FAERS data to identify cases of drug-induced photosensitivity (DIP), examine demographic patterns, determine the drug classes involved, and highlight emerging trends in these reactions. Additionally, we explore potential signal drugs by mining the relevant reported data, aiming to provide insights for safer clinical use of medications. We reviewed the publicly available FAERS database from 2004 to 2023. Using DIP-related search terms such as "photosensitivity reaction," "polymorphic light eruption," or et al., we identified reports of DIP. The frequency and trends of these reports were then analyzed. Between 2004 and 2023, the FDA received 17,384,824 reports of adverse reactions, with 20,236 of these linked to DIP. After excluding cases with incomplete data on age, gender, or country of origin, the median patient age was 52 years (IQR = 66). Females comprised 55.71% of the cases (11,274), and 66.96% (12,459) of the reports originated from the United States. The top 45 drugs were responsible for 9,810 cases (48.48%). The three drug classes most commonly associated with DIP in the FAERS database were immunosuppressants, monoclonal antibodies, and antineoplastic agents. A disproportionality analysis of the top drugs revealed several newly identified drugs with signals for photosensitivity, including adalimumab, adapalene, secukinumab, and fingolimod. By analyzing publicly available FAERS data, we identified key themes and trends in DIP reactions. Immunosuppressants and monoclonal antibodies show mild trends in DIP occurrence. Additionally, adalimumab, adapalene, secukinumab, and fingolimod are novel drug signals of DIP.

摘要

本研究的目的是分析美国食品药品监督管理局不良事件报告系统(FAERS)的数据,以识别药物性光敏反应(DIP)病例,研究人口统计学模式,确定涉及的药物类别,并突出这些反应中的新趋势。此外,我们通过挖掘相关报告数据来探索潜在的信号药物,旨在为药物的更安全临床使用提供见解。我们回顾了2004年至2023年公开可用的FAERS数据库。使用与DIP相关的搜索词,如“光敏反应”“多形性日光疹”等,我们确定了DIP报告。然后分析这些报告的频率和趋势。2004年至2023年期间,美国食品药品监督管理局收到了17384824份不良反应报告,其中20236份与DIP有关。在排除年龄、性别或原籍国数据不完整的病例后,患者年龄中位数为52岁(四分位间距 = 66)。女性占病例的55.71%(11274例),66.96%(12459例)的报告来自美国。前45种药物导致了9810例病例(48.48%)。FAERS数据库中与DIP最常相关的三类药物是免疫抑制剂、单克隆抗体和抗肿瘤药物。对顶级药物的不成比例分析揭示了几种新发现的有光敏性信号的药物,包括阿达木单抗、阿达帕林、司库奇尤单抗和芬戈莫德。通过分析公开可用的FAERS数据,我们确定了DIP反应的关键主题和趋势。免疫抑制剂和单克隆抗体在DIP发生方面呈现温和趋势。此外,阿达木单抗、阿达帕林、司库奇尤单抗和芬戈莫德是DIP的新型药物信号。

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