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人性化万科米辛输液对功能和损伤在翻译性大鼠模型中的影响

Jack Chang¹, Gwendolyn M Pais², Raymond Jubrail³

¹Department of Pharmacy Practice, Midwestern University College of Pharmacy, Downers Grove, IL, USA; Midwestern University College of Pharmacy, Pharmacometrics Center of Excellence, Downers Grove, IL, USA; Department of Pharmacy, Northwestern Memorial Hospital, Chicago, IL, USA.

International journal of antimicrobial agents

|February 28, 2024

概括

与人性化输液相比,传统的万科米辛剂量测量在老鼠中产生了与人性化输液相比类似的损伤结果和暴露. 这表明与剂量相匹配的玻尿酸注射是一种可行的临床前策略.

科学领域:

药理学和毒理学药理学和毒理学
科和脏研究研究.
临床前药物开发临床前药物开发

背景情况:

全米剂量缩放是临床前药理动力学/药理动力学 (PK/PD) 模型的标准,其目标是对人类和动物的异比暴露.
在临床前脏损伤研究中,以全米缩放的玻尿酸注射是常见的,但人性化的输液策略为精细暴露提供了潜力.
剂量匹配玻尿酸与人性化输液在万科迈辛诱导的损伤模型中的比较有效性仍然没有表征.

研究的目的:

为了在老鼠模型中比较传统的全尺度缩放,剂量匹配,玻尿酸甘的施用与人性化的输液方案.
为了评估两种施用方法之间的iohexol测量功能和尿路损伤生物标志物的差异.

主要方法:

使用临床前的Sprague-Dawley大鼠模型来治疗万科米辛诱导的损伤.
通过剂量匹配的玻璃注射和输液控制的人性化输液进行静脉输入万科米辛的比较.
监测的IOhexol测量膜过率 (GFR) 和尿路生物标志物:损伤分子-1 (KIM-1),集群蛋白和骨质蛋白.

主要成果:

两组在24小时后 (P = 0.07) 获得了同等的曲线下的面积 (AUC) 范科米辛暴露量.
在玻尿酸和输液组之间检测到的IOHEXOL测量的GFR没有显著差异.
尿路损伤生物标志物 (KIM-1,clusterin,osteopontin) 在服用策略之间没有显著差异.

结论:

通过人性化的输液或剂量匹配的玻尿酸输入静脉注射万科米辛,导致雄性斯普拉格-道利大鼠的万科米辛暴露率相似.
两种剂量方法之间没有观察到功能 (GFR) 或尿损伤生物标志物的显著差异.
剂量匹配的玻尿酸注射与度缩放代表了万科米辛脏损伤研究的可行和有效的临床前策略.

关键词:

所有度测量剂量测定方法造成脏损伤的人.范科米辛是一种药物.

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