与药物相关的眼睛干燥风险的真实世界大样本评估:基于FDA不良事件报告系统数据库
Shi-Nan Wu1, Caihong Huang1, Yu-Qian Wang1
1Xiamen 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.
Asia-Pacific journal of ophthalmology (Philadelphia, Pa.)
|September 29, 2024
概括
这项研究确定了33种药物显著增加干眼风险,其中异丁,tisotumab vedotin和布里莫尼丁具有最高风险. 早期出现的干眼与呼吸道药物有关,主要影响女性.
科学领域:
- 药监督和临床药理学.
- 在药物安全方面,现实世界的证据.
背景情况:
- 干眼病 (DED) 是一种普遍的疾病,具有多因素的原因.
- 识别药物诱导的DED对于患者安全和有效管理至关重要.
- 目前对DED特定药物风险的理解需要使用真实世界的数据进行持续评估.
研究的目的:
- 通过使用现实世界的数据来评估与药物相关的干眼风险.
- 为了确定与干眼风险增加相关的特定药物.
- 分析不同临床类型干眼病的药理病因.
主要方法:
- 来自食品和药物管理局不良事件报告系统 (FAERS) 数据库 (2004年1月 - 2023年9月) 的不良事件报告的分析.
- 不成比例分析和贝叶斯信任传播神经网络 (BCPNN) 算法的应用.
- 药物的分类,风险评估和基于药物相关干眼不良反应发病时间的细分分析.
主要成果:
- 与干眼相关的不良反应报告了1160种药物.
- 不成比例性分析发现33种药物具有显著的干眼风险,包括眼科,瘤和其他药物.
- 风险最高的药物包括:异丁氨酸 (BCPNN=6.88),提索托马布维多丁 (BCPNN=6.88),和布里莫尼丁 (BCPNN=6.77).
- 呼吸道药物显示最短的平均发病时间 (50.99天).
- 女性 (69.9%) 的干眼风险更高,特别是绝经期和老年人 (45-70岁).
- 观察到与药物相关的干眼报告每年增加.
结论:
- 有信息的临床决策对于预防与药物相关的眼睛干燥至关重要.
- 评估与局部和全身药物相关的风险可以优化治疗,并提供必要的警告信息.
- 药物监测工作对于识别和减轻干眼等药物诱导的不良事件至关重要.
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