根据FDA的不良事件报告系统,探索与药物诱导便秘相关的前30种药物
Wenwen Li1, Cuncheng Liu2, Zhongyi Zhang1
1Second School of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.
这项研究在FDA不良事件报告系统数据库中确定了26种具有明显便秘风险信号的药物. 四种药物显示出意想不到的便秘风险,为容易出现药物诱导便秘的患者提供了潜在的药物替代方案.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床药理学 临床药理学
背景情况:
- 便秘是一种常见的不良药物事件 (ADE).
- 识别与便秘相关的药物对于患者的安全至关重要.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 数据库是药物监测的宝贵资源.
研究的目的:
- 确定最常与便秘相关的前30种药物.
- 用统计方法评估这些药物对便秘风险的信号强度.
- 分析已识别药物的便秘发病时间.
主要方法:
- 从FAERS (2004-2023) 中提取了与便秘相关的ADEs.
- 根据便秘事件的频率排名前30名的药物.
- 应用信号检测方法 (ROR,PRR,MGPS,IC) 和时间到发病 (TTO) 分析.
主要成果:
- 在50,659,288个ADE中,发现了169,897个便秘的ADE.
- 在前30种药物中,26种药物显示出明显的便秘风险信号.
- 四种药物 (orlistat,nintedanib,palbociclib,dimethyl fumarate) 显示出意想不到的便秘风险;塞维拉默碳酸盐具有最强的信号. 所有药物都显示出早期的TTO.
结论:
- 本研究提供了一份与药物诱导便秘 (DIC) 相关的药物清单.
- 这些发现可以帮助临床医生考虑为患有DIC风险的患者提供替代药物.
- 减少DIC发病率和死亡率是一个关键的临床影响.
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