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首页> 外文期刊>Investigative radiology >Preclinical safety and pharmacokinetic profile of ferumoxtran-10, an ultrasmall superparamagnetic iron oxide magnetic resonance contrast agent.
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Preclinical safety and pharmacokinetic profile of ferumoxtran-10, an ultrasmall superparamagnetic iron oxide magnetic resonance contrast agent.

机译：Ferumoxtran-10（一种超小型超顺磁性氧化铁磁共振造影剂）的临床前安全性和药代动力学特性。

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OBJECTIVES: This report presents an overview of preclinical data available on ferumoxtran-10, an ultrasmall superparamagnetic iron oxide nanoparticular contrast agent proposed for lymph node magnetic resonance imaging. MATERIALS AND METHODS: Pharmacokinetic, safety pharmacology, single- and repeat-dose toxicity, reproduction toxicity, and genotoxicity studies were performed with ferumoxtran-10 given intravenously (bolus injection) in mice, rats, rabbits, dogs, and monkeys. RESULTS: Ferumoxtran-10 was taken up by macrophages, mostly in liver, spleen, and lymph nodes, within 24 hours after bolus injection and underwent progressive metabolism. Toxicity was observed only at very high exposure levels and mainly was linked to a massive iron load after repeated injections. Ferumoxtran-10 was not mutagenic but was teratogenic in rats and rabbits. DISCUSSION: The preclinical pharmacokinetic and safety profile of ferumoxtran-10 appears to be satisfactory in view of its proposed use as a single-dose diagnostic agent in human for MR imaging of lymph nodes.
机译：目的：本报告概述了可用于淋巴结磁共振成像的超小型超顺磁性氧化铁纳米颗粒造影剂ferumoxtran-10的临床前数据概述。材料与方法：用ferumoxtran-10在小鼠，大鼠，兔子，狗和猴子中静脉内（推注）进行药代动力学，安全药理学，单次和重复剂量毒性，生殖毒性和基因毒性研究。结果：推注后24小时内，巨噬细胞摄取了Ferumoxtran-10，主要在肝脏，脾脏和淋巴结中吸收，并进行了逐步代谢。仅在非常高的暴露水平下才观察到毒性，并且主要与重复注射后大量铁负荷有关。 Ferumoxtran-10对大鼠和兔子无致突变性，但具有致畸性。讨论：鉴于ferumoxtran-10拟用作人类单剂量诊断剂用于淋巴结MR成像的临床建议，其临床前药代动力学和安全性似乎令人满意。

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