特兰胺酸的安全性评估:来自FAERS数据库的现实世界不良事件分析
Ningsheng Tian1, Yuxin Sun1, Yingying Liu1
1Department of Orthopaedics, The Second Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Frontiers in pharmacology
|June 12, 2024
概括
特兰胺酸 (TXA) 的使用正在增加,但安全问题仍然存在. 这项研究确定了被忽视的不良反应,包括神经系统疾病和罕见但严重的事件,突出了需要更好的监测和患者安全.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 现实世界的证据.
背景情况:
- 特兰胺酸 (TXA) 广泛用于控制出血.
- 由于对不良反应的持续担忧,越来越多的TXA应用需要进行彻底的安全评估.
- 现实世界的数据分析对于理解TXA的全面安全概况至关重要.
研究的目的:
- 通过使用现实世界的数据,调查与特兰胺酸 (TXA) 相关的不良药物事件.
- 识别和描述被忽视或报告不足的TXA的不良反应.
- 为优化TXA患者治疗和安全协议提供见解.
主要方法:
- 来自美国食品和药物管理局 (FDA) 的TXA不良药物事件数据分析,涵盖2004年第一季度至2023年第三季度.
- 收集数据的标准化,以便进行可靠的分析.
- 应用多种信号量化技术,包括报告赔率比率,比例报告比率,贝叶斯信任传播神经网络和经验贝叶斯几何平均值.
主要成果:
- 在超过1660万份报告中,共发现了1574起与TXA相关的不良事件.
- 神经系统疾病是最常见的报告 (n=785),包括肌细胞,状态和肌细胞.
- 罕见但高信号的不良事件,如皮层缩和肝脏囊破裂被确定,以及频繁的高信号事件,如视网膜动脉封闭和血管支架血栓形成障碍. 产品混占78个案例.
结论:
- 特兰胺酸 (TXA) 呈现出几种可能被低估的不良反应.
- 有效监测和管理这些不良反应对于安全使用TXA至关重要.
- 需要进一步的研究和更新的临床指导方针来解决发现的安全问题.
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