罗莫苏祖马布不良事件概况:基于2019年至2023年的FDA不良事件报告系统 (FAERS) 的药监测分析
Luyu Liu1, Shaobo Wu2, Liangliang Wei1
1Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, 710054, Shaanxi, China.
Aging clinical and experimental research
|January 14, 2025
概括
这项研究分析了romosozumab不良药事件 (ADEs) 从2019-2023. 这些发现突出了潜在的新安全信号,包括骨折和异常的骨密度,有助于对骨质疏松症治疗的临床监测.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床药理学 临床药理学
背景情况:
- 罗莫索祖马布是一种用于治疗骨质疏松症的药物.
- 了解其不良药物事件 (ADE) 概况对于患者安全至关重要.
- 营销后监测对于识别潜在的安全信号至关重要.
研究的目的:
- 分析与romosozumab相关的不良药物事件 (ADEs).
- 从大型不良事件数据库中识别和量化安全信号.
- 提供支持romosozumab安全临床使用的数据.
主要方法:
- 利用FAERS数据库从2019年第二季度到2023年第三季度的ADE数据.
- 采用了四种信号量化算法:报告几率比率 (ROR),比例报告比率 (PRR),贝叶斯信心传播神经网络 (BCPNN) 和经验贝叶斯几何平均值 (EBGM).
- 对统计学上显著的药物不良反应 (ADR) 信号进行了选23个系统器官类别 (SOC) 和首选术语 (PT).
主要成果:
- 确定了7055份报告,其中罗莫苏祖马布作为主要嫌疑人 (PS).
- 在一般性疾病,注射部位疾病,肌肉骨和结缔组织疾病中检测到显著信号.
- 值得注意的信号包括骨折 (ROR=107.8) 和异常的骨密度 (ROR=343.65),信号强度高.
结论:
- 该研究确定了romosozumab的潜在新不良事件信号.
- 调查结果提供了数据,以支持romosozumab的持续安全监测.
- 临床医生被提醒监测特定的不良反应,帮助骨质疏松症的合理处方.
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