在使用Roxadustat治疗甲状腺功能低下症的不成比例分析中,使用日本不良药物事件数据库
Yasunobu Kouki1,2, Naoto Okada3, Kosuke Saga4
1Center for Clinical Research, Yamaguchi University Hospital, Yamaguchi, Japan.
Journal of clinical pharmacology
|July 6, 2023
概括
低氧诱导因子基酶抑制剂 (HIF-PHIs) 治疗贫血. 罗沙沙斯塔特是一种HIF-PHI,可能会导致甲状腺功能低下,与其他药物不同. 在roxadustat治疗期间建议对甲状腺功能进行监测.
科学领域:
- 药物监督 药物监督 药物监督
- 腎臟病學 (nephrology) 是一種醫學.
- 内分泌学 在内分泌学.
背景情况:
- 低氧诱导因子基酶抑制剂 (HIF-PHI) 是治疗贫血的新药.
- HIF-PHI的功能是通过增加红素蛋白的产量来发挥作用.
- 由于它们的新机制,人们对潜在的不良事件存在担忧.
研究的目的:
- 评估HIF-PHI对甲状腺功能的临床影响.
- 在现实环境中评估与roxadustat相关的甲状腺功能低下风险.
- 分析来自日本药物不良事件报告数据库的数据.
主要方法:
- 使用了日本不良药物事件报告数据库.
- 分析了HIF-PHI给药后出现不良事件的自发报告.
- 计算报告几率比率 (ROR) 和95%置信区间 (CI) 的甲状腺功能低下症.
主要成果:
- 在roxadustat (ROR: 22.1,95% CI: 18.3-26.7) 检测到甲状腺功能低下的显著不成比例信号.
- 没有发现使用达普罗杜斯塔特或 epoetin beta pegol 的甲状腺功能低下的显著信号.
- 对于roxadustat的甲状腺功能低下信号在年龄和性别人口统计学上是一致的,约50%的病例在开始后50天内报告.
结论:
- 罗沙杜沙特的使用可能与甲状腺功能低下症的发展有关.
- 在roxadustat治疗期间建议对甲状腺功能进行监测.
- 需要进一步评估HIF-PHI对甲状腺功能的影响.
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