印度复杂尿路感染患者的血素药理动力学:来自第二阶段研究的子组分析
Vaishali Gupte1, Sandesh Sawant1, Senthilnathan Mohanasundaram1
1Medical Affairs, Cipla Ltd., Mumbai, India.
Clinical pharmacology in drug development
|October 19, 2025
概括
这项研究发现,在患有复杂尿路感染的印度和非印度患者中,血素的药理动力学参数相似. 青素在不同人群中显示出可比的药物暴露,支持其在全球治疗指南中的使用.
科学领域:
- 药理学和传染病的研究
- 临床药理动力学 临床药理动力学
- 抗微生物耐药性 抗微生物耐药性
背景情况:
- 耐多药性肠杆菌是复杂的尿路感染 (CUTIs) 的重要原因.
- 了解不同人群中的药物药理动力学 (PK) 对于有效治疗至关重要.
- 青素是一种氨基糖化物抗生素,用于治疗CUTIs.
研究的目的:
- 为了比较印度和非印度参与者之间的血素的药理动力学 (PK) 参数.
- 为了评估患有复杂尿路感染或急性肌炎的患者的血素暴露.
主要方法:
- 来自第二阶段多中心,双盲,随机化研究 (ACHN-490-002) 的PK数据的后期分析.
- 参与者 (年龄18-85岁,体重≤100公斤) 接受了10或15毫克/公斤的血素.
- 分析了PK参数,包括血时间度曲线下的面积 (AUC0-24) 和最大度 (Cmax).
主要成果:
- 服用15毫克/千克的血素显示AUC0-24和Cmax高于10毫克/千克的剂量,变化更大.
- 在10毫克/千克的剂量中,印度参与者的平均AUC0-24为163.0毫克/小时,非印度参与者的平均AUC0-24为185.0毫克/小时.
- 印度参与者的平均Cmax为17.2 mg•h/L,非印度参与者的平均Cmax为15.7 mg•h/L,这表明不同组的等离子素暴露程度可比.
结论:
- 在印度和非印度参与者之间,估计的平均血素AUC0-24值是可比的.
- 剂量正常化的PK参数 (AUC0-24和Cmax) 类似,表明可比的等离子素暴露.
- 这些发现支持在不同患者群体中使用等离子素治疗复杂的尿路感染.
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