在儿科移植患者中Envarsus的药理动力学 - 第1阶段试点转换研究
Jon Jin Kim1,2, Laura Lawless3, David Marshall4
1Department of Paediatric Nephrology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Pediatric transplantation
|March 4, 2024
概括
这项试点研究表明,延长释放塔克罗利木斯 (LCP-tac) 与儿童脏移植患者每天两次服用塔克罗利木斯 (BD-tac) 相比,具有更好的药理动力学特征. LCP-tac表现出更可预测的释放,支持其在儿童中的潜在使用.
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.
- 儿科移植医学 儿科移植医学
背景情况:
- 塔克罗利斯是一种标准的每日两次 (BD-tac) 免疫抑制剂,用于儿科移植.
- 延长释放配方Envarsus (LCP-tac) 已批准用于成人,但尚未批准用于儿科患者.
研究的目的:
- 为了比较延长释放塔克罗利斯 (LCP-tac) 与每天两次服用塔克罗利斯 (BD-tac) 的药理动力学 (PK) 在稳定的儿科脏移植接受者中.
- 在这个人群中评估LCP-tac转换的安全性和有效性.
主要方法:
- 在小儿移植接受者 (<18岁) 中进行了一项开放式试点第一阶段研究.
- 进行了两项24小时的PK研究:转换前 (BD-tac) 和转换后4周的LCP-tac.
- 患者在转化后被跟踪了6个月.
主要成果:
- 五名患者完成了这项研究,无需恢复BD-tac.
- 与BD-tac相比,LCP-tac显示出延长释放的特征,最大度的延迟时间和较低的峰值度.
- 塔克罗利木斯的暴露 (曲线下的面积) 是可比的,并且没有观察到新的安全问题或移植 rejection. 转换比率为0.6 (BD-tac:LCP-tac). 这是一个很好的例子.
结论:
- 这项试点研究证实了延长释放药物动力学特征,并改善了儿童脏移植患者的LCP-tac与BD-tac相比的吸收.
- 需要进行更大规模的研究,以进一步评估人口PK特征和儿童LCP-tac的长期结果.
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