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引起睑板腺功能障碍的药物的真实世界分析:基于美国食品药品监督管理局不良事件报告系统数据库

Real-world analysis of medications inducing meibomian gland dysfunction: based on the FDA adverse event reporting system database.

作者信息

Li Xiang, Wu Shi-Nan, Zhang Si-Qi, Zhang Zhi-Jie, Wang Meng-Yuan, Chen Cui-Ting, Luo Zhan-Yang, Dong Nuo

机构信息

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

Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, School of Medicine, Xiamen University, Xiamen, Fujian, China.

出版信息

Expert Opin Drug Saf. 2025 Jan 5:1-9. doi: 10.1080/14740338.2024.2446430.

Abstract

BACKGROUND

Dry eye syndrome (DES) significantly affects quality of life. Meibomian Gland Dysfunction (MGD) is a primary contributor to DES and may be drug-induced.

RESEARCH DESIGN AND METHODS

This study analyzed data from the FDA Adverse Event Reporting System (FAERS) between January 2004 and September 2023 using the Ratio of Odds Ratios (ROR) and Proportional Reporting Ratio (PRR) to detect potential drug-induced MGD signals. Drugs were categorized by therapeutic class.

RESULTS

Among 289 MGD cases, the average patient age was 51.69 years, with 65.44% female. MGD reports have increased over time, peaking in 2023, primarily from the United States and Europe. Of 148 drugs, nine showed significant associations with MGD, including those in ophthalmology, oncology, immunomodulation, dermatology, and the urogenital system.

CONCLUSION

This real-world study identifies drugs potentially linked to MGD, offering valuable insights for drug safety surveillance. These findings support the development of pharmacovigilance strategies and optimized clinical practice to mitigate ocular risks.

摘要

背景

干眼综合征(DES)显著影响生活质量。睑板腺功能障碍(MGD)是DES的主要促成因素,且可能由药物引起。

研究设计与方法

本研究分析了2004年1月至2023年9月期间来自美国食品药品监督管理局不良事件报告系统(FAERS)的数据,使用比值比(ROR)和比例报告比(PRR)来检测潜在的药物性MGD信号。药物按治疗类别分类。

结果

在289例MGD病例中,患者平均年龄为51.69岁,女性占65.44%。MGD报告随时间增加,在2023年达到峰值,主要来自美国和欧洲。在148种药物中,有9种与MGD存在显著关联,包括眼科、肿瘤学、免疫调节、皮肤病学和泌尿生殖系统的药物。

结论

这项真实世界研究确定了可能与MGD相关的药物,为药物安全监测提供了有价值的见解。这些发现支持制定药物警戒策略和优化临床实践以降低眼部风险。

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