对于患有高酸血症的腹膜透析患者的Tenapanor:一个第三阶段试验
Masaaki Nakayama1, Shuhei Kobayashi2, Miho Kusakabe2
1Kidney Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, 104-8560, Japan. nakayama@luke.ac.jp.
Clinical and experimental nephrology
|November 1, 2023
概括
在日本透析患者中,Tenapanor有效降低了血清. 这种新的治疗方法是安全的,耐受性很好,腹是最常见的副作用.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 药理学 药理学是指药理学的学科.
背景情况:
- 松剂是肠道/交换器3载体的选择性抑制剂,目前正在对高血症的管理进行评估.
- 这项研究是首次评估在接受腹膜透析的日本患者中tenapanor的疗效和安全性.
研究的目的:
- 为了评估tenapanor在日本患者的有效性和安全性,在腹腔透析中患有高血症.
主要方法:
- 一个第三阶段,开放标签,多中心,单臂试验,涉及54名患者.
- 患者每天服用两次口服天巴诺,剂量逐步从5毫克增加到30毫克,持续16周.
- 主要终点是第8周血清水平的平均变化.
主要成果:
- 松剂在第8周显著降低了血清的-1.18 mg/dL (主要终点).
- 血清水平从基线的7.65 mg/dL下降到第16周的5.44 mg/dL.
- 76.5%的患者在第16周达到水平 (3.5-6.0 mg/dL).
结论:
- 十巴诺尔在第八周显示血清含量有足够的降低.
- 治疗被发现是安全的,并且在这个患者群体中耐受良好.
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