在日本血液透析患者中对upacicalcet进行二次性偏甲状腺功能障碍症的第二阶段研究:一个个体内剂量调整研究
Daijo Inaguma1, Fumihiko Koiwa2, Masanori Tokumoto3
1Department of Internal Medicine, Fujita Health University Bantane Hospital, Aichi, Japan.
Clinical kidney journal
|December 4, 2023
概括
乌帕西卡塞特有效地管理了52周的血液透析患者的二次性副甲状腺功能障碍. 仿剂显示出高疗效和良好的安全性概况,随着个体内剂量调整.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 内分泌学 在内分泌学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 二次性偏甲状腺症 (SHPT) 是血液透析患者的常见并发症.
- 模仿剂对于在这个人群中管理SHPT至关重要.
- 乌帕西卡塞特是一种新的小分子仿药,用于静脉注射.
研究的目的:
- 评估Upacicalcet的长期疗效和安全性.
- 评估SHPT的血液透析患者的个体内剂量调整.
- 确定乌帕西卡尔塞特在达到目标完整副甲状腺激素 (iPTH) 水平方面的有效性.
主要方法:
- 一个为期52周的,第二阶段,多中心,开放标签,单臂研究.
- 乌帕西卡塞特与个人内剂量调整 (25-300μg) 一起使用.
- 主要终点:在第18周实现目标IPTH (60-240 pg/mL) 的患者百分比.
主要成果:
- iPTH的目标实现率从18周的57.9%增加到52周的80.8%.
- 血清校正的水平最初下降,但保持稳定.
- 在94.8%的患者中发生了不良事件;调整后的减少是最常见的 (20.7%的不良反应).
结论:
- 乌帕西卡塞特 (25-300μg) 在血液透析患者的长期SHPT治疗中非常有效.
- 该药物耐受性良好,但存在轻微的安全问题.
- 剂量调整可以有效控制iPTH和水平.
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