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关于Upadacitinib的营销后安全问题:对FDA不良事件报告系统的不成比例分析
Xiang-Ping Wu1,2,3, Xi-Kui Lu1,2,3, Zhen-Ting Wang1,2,3
1Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, China.
Expert opinion on drug safety
|June 13, 2023
概括
这项研究分析了美国FDA的数据,以确定与治疗炎症病症的药物上达西提尼布相关的不良事件 (AE). 它揭示了潜在的新安全信号,有助于临床监测.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床研究 临床研究
背景情况:
- 乌帕达西替尼 (Upadacitinib) 已批准用于类风湿性关节炎,牛皮,性结肠炎,化性脊柱炎和亚托邦性皮肤炎.
- 与upadacitinib相关的不良事件 (AE) 需要持续评估.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 是药物监测的关键数据来源.
研究的目的:
- 评估与upadacitinib相关的不良事件 (AEs).
- 通过不成比例性分析,识别潜在的新安全信号.
- 为了支持临床监测和风险识别,用上达西提尼治疗.
主要方法:
- 使用不成比例分析:报告赔率比率 (ROR),比例报告比率 (PRR),贝叶斯信心传播神经网络 (BCPNN) 和多项马波森收缩器 (MGPS).
- 分析了来自美国食品和药物管理局不良事件报告系统 (FAERS) 的数据.
- 从大量AE报告数据集中,量化了与upadacitinib相关的AE信号.
主要成果:
- 从超过380万份AE报告中确定了4494份AE报告,其中upadacitinib是主要的嫌疑人.
- 在27个系统器官类 (SOC) 中检测到200个显著不成比例的信号.
- 观察到意想不到的不良事件,包括关节痛,肌肉骨硬度,分泌体炎和白内障,平均发病时间为65天,大多是在治疗的前四个月内.
结论:
- 该研究确定了对upadacitinib的潜在新不良事件信号.
- 结果可以告知和加强临床监测策略.
- 这项研究支持对使用upadacitinib的患者进行更好的风险识别.
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