在临床使用的第一年之后,加多皮克伦醇的安全性
Alberto Spinazzi1, Eric Lancelot, Letizia Vitali
1From Global Medical and Regulatory Affairs, Bracco Group, Milan, Italy (A.S., L.V., G.P., M.A.K.); and Medical, Pharmacovigilance, and Regulatory Affairs, Guerbet Group, Villepinte, France (E.L., C.C., A.J., E.D.-K., P.B.).
Investigative radiology
|December 18, 2024
概括
加多皮克伦醇是一种新的MRI对比剂,在临床使用的第一年显示出极好的安全性. 营销后监测没有发现任何严重的不良事件,证实了其有利的利益风险概况.
科学领域:
- 放射学 放射学是一门学科.
- 药物监督 药物监督 药物监督
- 医疗成像医学成像
背景情况:
- 加多皮克伦醇是一种新的宏环,高放松度的加多基对比剂.
- 它已被批准用于中枢神经系统和身体器官的磁共振成像 (MRI).
研究的目的:
- 在美国临床使用的第一年评估加多皮克伦醇的安全性和耐受性.
- 评估与加多皮克伦醇 (gadopiclenol) 管理相关的不良事件 (AE) 的发生率和类型.
主要方法:
- 分析了美国临床使用的第一年营销后监测数据.
- 超过882,550次加多皮克伦醇的使用被纳入了分析.
主要成果:
- 在加多皮克伦醇给药后,没有报告严重不良事件 (AEs).
- 观察到非常低的非严重的AE率 (每27,580次暴露中有1例).
- 观察到的副作用类型与其他基于加多的对比剂类型相似.
结论:
- 营销后监测证实了加多皮克伦醇的积极益处风险概况.
- 加多皮克伦醇在现实临床实践中表现出良好的安全性.
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