与加多暴露相关的症状:线性和宏循环的加多基对比剂之间的不同模式和速率
1From the Vigilance and Medical Information Department, Guerbet, Roissy CDG Cedex, France.
Investigative radiology
|February 14, 2025
概括
与线性GBCA相比,基于加多的宏循环对比剂 (GBCA) 显示了与加多暴露 (SAGE) 相关的症状发生率明显较低. 使用宏循环剂的SAGE症状与含的对比剂相当,这表明它们可能是可以忽略不计的.
科学领域:
- 药物监督 药物监督 药物监督
- 放射学 放射学是一门学科.
- 对比介质安全性 对比介质安全性
背景情况:
- 接受多次加多基对比剂 (GBCA) 治疗的患者可能会出现与加多暴露 (SAGE) 相关的症状.
- 了解不同GBCA类型的安全性概况对于临床实践至关重要.
研究的目的:
- 分析与线性和宏循环GBCA相关的SAGE模式的药监数据.
- 为了比较线性和宏循环GBCA之间的SAGE症状的发生率和类型.
主要方法:
- 利用了2014-2019年FDA不良事件报告系统 (FAERS) 的数据.
- 在3+SAGE症状的患者中,分析了3个线性和3个宏循环GBCA的SAGE首选术语 (PT).
- 计算了SAGE重量和分析了3-PT组合,与含的对比介质进行比较.
主要成果:
- 线性GBCA的SAGE重量 (20%-24%) 比宏环GBCA (5%-9%) 高得多.
- 线性GBCA的3 - PT组合的流行发生了152-164次,而宏环GBCA的1 - 13次.
- 确定了不同GBCA类型的独特SAGE模式;常见症状包括疼痛,关节痛和头痛.
结论:
- 与线性GBCA相比,宏循环GBCA的SAGE负担明显较低.
- 麦克罗环球GBCA的SAGE发生率与含的对比剂可比,这表明潜在的可忽略性.
- 进一步的研究和常规的药监测是有必要的,以确定因果关系.
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