在骨质疏松症中使用德诺苏马布和罗莫苏马布的比较安全性:基于FDA不良事件报告系统数据库的分析
Jian Sun1,2, Ciren Lunzhu3, Yao Wu4
1Department of Orthopedics, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, China.
Frontiers in medicine
|February 23, 2026
概括
德诺苏马布显示了骨和代谢问题的长期风险,而罗莫苏马布则存在急性心血管风险. 这两种骨质疏松症药物都具有不同的安全性,其中denosumab与骨质免疫事件有关,romosozumab与注射部位反应有关.
科学领域:
- 药物监督 药物监督 药物监督
- 免疫学 免疫学 免疫学
- 骨质疏松症治疗药物 骨质疏松症治疗药物
背景情况:
- 德诺苏玛布和罗莫苏玛布是用于骨质疏松症的生物药物,具有潜在的免疫调节作用.
- 了解它们的比较安全性,特别是与免疫相关的不良反应,对于临床实践至关重要.
研究的目的:
- 为了比较denosumab和romosozumab的安全性概况.
- 专门调查与这些骨质疏松症治疗相关的免疫相关不良反应.
- 利用来自FDA不良事件报告系统 (FAERS) 的现实数据来检测安全信号.
主要方法:
- 从FAERS提取了2019年第二季度到2025年第二季度的登苏马布和罗莫苏马布的数据.
- 采用不成比例分析和贝叶斯方法来稳定检测安全信号.
- 应用标准化数据清理程序以确保数据完整性.
主要成果:
- 代诺苏马布 (38,784份报告) 在肌肉骨和代谢障碍方面显示出长期风险.
- 罗莫苏祖马布 (10,007份报告) 与急性心血管风险有关,包括冠状动脉疾病和心力衰竭.
- 免疫相关事件包括denozumab的骨免疫并发症 (牙周炎) 和romosozumab的注射部位反应.
结论:
- 德诺苏马布和罗莫苏马布具有不同的安全性.
- 德诺苏马布与累积风险和骨免疫事件有关,而罗莫苏马布则具有急性心血管风险.
- 通过了解这些药物特定的安全特征,可以提高有关个性化骨质疏松症治疗的知情临床决策.
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