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在青少年非人类灵长类动物中对基对比剂的评估,包括诸如学习和记忆等行为评估

Daniela Smieja¹, Oliver Czupalla², Clemens Günther²

¹Labcorp Early Development Services GmbH, Münster, Germany.

Birth defects research

|April 16, 2025

概括

基于加多的对比剂 (GBCA) 没有对幼的发育,学习或记忆产生不良影响,即使重复高剂量. 这表明GBCA在发育过程中的暴露没有长期风险.

科学领域:

毒理学毒理学毒理学
发展生物学发展生物学
药理学药理学是指药理学的学科.

背景情况:

美国食品和药物管理局 (FDA) 授权对加多基对比剂 (GBCA) 的加多保留进行调查.
研究重点关注胎儿和新生儿发育,以及重复给予GBCA对神经和组织病理终点的影响.

研究的目的:

评估基于加多的对比剂 (GBCA) 在未成年非人类灵长类动物中的安全性.
研究GBCA暴露对行为,神经功能和组织病理学的潜在长期影响.

主要方法:

年轻的Cynomolgus子接受了线性 (gadodiamide,gadobenate dimeglumine) 和宏环性 (gadobutrol) GBCAs的多次静脉注射剂.
综合性评估包括临床观察,组织病理学和详细的行为/神经测试 (学习,记忆).
在大脑和其他组织中量化了加多水平;研究包括剂量和恢复阶段.

主要成果:

没有观察到与基对比剂相关的不良影响,在年轻的子中服用后或康复期间.
确定了无观察效应水平 (NOEL),所有测试的GBCA的无观察不良效应水平 (NOAEL) 至少为0.9 mmol/kg.

结论:

大脑组织中的加多水平与未成年子的不良形态或功能发现无关.
在发育过程中GBCA暴露没有证据表明长期行为,神经或学习/记忆障碍的风险.

关键词:

行为行为行为行为.脑部暴露脑部暴露卡多利尼姆 (gadolinium) 是一种电子产品.学习和记忆的学习和记忆.非人类灵长类的灵长类.毒性动力学毒性动力学

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