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, Fujian 361005, China.
Department of Oncology, Xiang'an Hospital of Xiamen University, Xiamen, Fujian 361005, China.
Asia Pac J Ophthalmol (Phila). 2024 Sep-Oct;13(5):100104. doi: 10.1016/j.apjo.2024.100104. Epub 2024 Sep 27.
This study aimed to evaluate the risk of drug-related dry eye using real-world data, underscoring the significance of tracing pharmacological etiology for distinct clinical types of dry eye.
Analyzing adverse event reports in the Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to September 2023, we employed disproportionality analysis and the Bayesian confidence propagation neural network algorithm. The analysis involved categorizing drugs causing dry eye, assessing risk levels, and conducting segmental assessments based on the time of onset of drug-related dry eye adverse reactions.
In the FAERS database, adverse reactions related to dry eye were linked to 1160 drugs. Disproportionality analysis identified 33 drugs with significant risk, notably in ophthalmic (brimonidine, bimatoprost), oncology (tisotumab vedotin, erdafitinib), and other medications (isotretinoin, oxymetazoline). The top three drugs with the highest risk of drug-related dry eye are isotretinoin (Bayesian confidence propagation neural network (BCPNN) = 6.88), tisotumab vedotin (BCPNN = 6.88), and brimonidine (BCPNN = 6.77). Among different categories of drugs, respiratory medications have the shortest mean onset time for drug-related dry eye, averaging 50.99 days. The prevalence skewed towards females (69.9 %), particularly in menopausal and elderly individuals (45-70 years old, mean age 54.7 ± 18.2). Reports of drug-related dry eye adverse reactions showed an annual increase.
Informed clinical decision-making is crucial for preventing drug-related dry eye. Assessing the risk of dry eyes associated with both local and systemic medications helps optimize treatment and provide necessary cautionary information.
本研究旨在利用真实世界数据评估药物相关性干眼的风险，强调追踪药理学病因对于不同临床类型干眼的重要性。
我们分析了 2004 年 1 月至 2023 年 9 月食品和药物管理局不良事件报告系统（FAERS）中的不良事件报告，采用了不相称性分析和贝叶斯置信传播神经网络算法。该分析包括对导致干眼的药物进行分类、评估风险水平，并根据药物相关性干眼不良反应的发生时间进行分段评估。
在 FAERS 数据库中，与干眼相关的不良反应与 1160 种药物有关。不相称性分析确定了 33 种具有显著风险的药物，特别是眼科（溴莫尼定、比马前列素）、肿瘤学（tisotumab vedotin、erdafitinib）和其他药物（异维 A 酸、羟甲唑啉）。药物相关性干眼风险最高的前三种药物是异维 A 酸（贝叶斯置信传播神经网络（BCPNN）=6.88）、tisotumab vedotin（BCPNN=6.88）和溴莫尼定（BCPNN=6.77）。在不同类别的药物中，呼吸系统药物发生药物相关性干眼的平均起始时间最短，为 50.99 天。报告的药物相关性干眼不良反应呈逐年增加趋势。
为了预防药物相关性干眼，明智的临床决策至关重要。评估局部和全身用药相关干眼的风险有助于优化治疗并提供必要的警示信息。
