在新型口服抗凝剂中寻找非出血不良事件的信号挖掘:基于FAERS数据库的药监测研究
Guimu Guo1, Ying Song1,2, Sijie Chang1
1Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China.
Naunyn-Schmiedeberg's archives of pharmacology
|August 13, 2025
概括
新型口服抗凝剂 (NOAC) 有显著的非出血不良反应,影响多个系统. 提高警对于安全的NOAC使用至关重要,因为每个药物都存在独特的安全问题.
科学领域:
- 药物监督 药物监督 药物监督
- 现实世界的证据分析分析.
- 监测药物安全,监测药物安全.
背景情况:
- 新型口服抗凝剂 (NOAC) 广泛使用,但非出血不良反应被低估.
- 现实世界的数据对于了解NOAC的完整安全概况至关重要.
研究的目的:
- 用现实数据分析与NOAC相关的非出血不良事件信号.
- 为了比较不同NOAC的安全性,并提供早期临床预警.
主要方法:
- 使用了FDA不良事件报告系统 (FAERS) 数据库 (2014年7月 - 2024年3月).
- 雇员报告几率比率 (ROR) 和贝叶斯信心传播神经网络 (BCPNN) 用于信号检测.
- 执行数据去重复和合并以进行全面分析.
主要成果:
- 在先天性,怀孕和血液/淋巴系统疾病中确定了显著的非出血不良反应信号.
- 对达比加特兰,阿皮克萨班,埃多克萨班和里瓦罗克萨班观察到明显的安全性概况和独特的不良事件.
- 在被忽视的系统中突出显示的不良事件,如生殖,内分泌和精神疾病.
结论:
- 非出血的NOACs不良影响需要更多的临床关注.
- 由于NOAC安全概况的差异,需要对患者进行个性化监测.
- 这项研究为改善临床实践提供了对NOAC不良反应的关键见解.
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