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对于血液透析患者的HSK21542的安全性和有效性:多重上升剂量研究
Mingming Pan1, Guihua Wang1, Li Zhou2
1Department of Nephrology, Zhong Da Hospital, Southeast University School of Medicine, Nanjing, China.
Frontiers in pharmacology
|October 25, 2023
概括
新型药物HSK21542有效降低了血液透析患者的. 这种局限于周围的 κ-阿片类受体激素体表现出良好的耐受性和线性药理动力学,支持进一步的试验.
科学领域:
- 药理学 药理学是指药理学的学科.
- 腎臟病學 (nephrology) 是一種醫學專業.
- 临床试验 临床试验
背景情况:
- HSK21542是一种新的,有选择性的,外围受限的 κ-阿片类受体激活剂.
- 之前的研究证实了其作为止痛和抗剂的安全性和有效性.
- 这项研究评估了血液透析患者的HSK21542,以确定未来试验的最佳剂量.
研究的目的:
- 评估HSK21542在血液透析患者的安全性,药理动力学和疗效.
- 为了确定12周的第二阶段试验的最佳剂量.
- 为了评估HSK21542在特定患者群体中的抗作用.
主要方法:
- 一项涉及血液透析患者的多重上升剂量研究.
- 随机分配给HSK21542 (0.05-0.80μg/kg) 或安慰剂,每周三次进行透析后.
- 安全性 (TEAE),药理动力学和疗效 (最坏的痛强度数值评分表,Skindex-16) 在1周的时间内进行了评估.
主要成果:
- 在44名查患者中,有41人完成了试验.
- 治疗出现的不良事件 (TEAE) 大多为1级或2级,HSK21542组的发病率较高 (50.0%-88.9%) 与安慰剂相比.
- HSK21542显示线性药理动力学,没有积累,并且在0.30μg/kg (p=0.046) 时显著降低了的评分,但不是Skindex-16评分.
结论:
- 在血液透析患者中,HSK21542在0.05-0.80μg/kg剂量范围内耐受良好.
- 0.30μg/kg的剂量显示出对中度至严重的有有希望的疗效.
- 需要进一步的第二阶段试验来证实这些发现.
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