随机对Tenapanor添加到酸盐结合剂的随机研究,用于耐火性高酸性血症患者
Kosaku Nitta1, Saki Itoyama2, Kazuaki Ikejiri2
1Department of Nephrology, Tokyo Women's Medical University, Tokyo, Japan.
在透析患者中,当添加到酸结合剂 (PBs) 时,Tenapanor有效降低了血清. 这种新的治疗方法改善了的控制,没有新的安全问题,为更好的高血症管理提供了希望.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 内部医学 内部医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 血清控制对于透析患者来说至关重要,以防止甲状腺功能障碍和血管化.
- 现有的酸盐结合剂 (PBs) 对一些患者来说是不够的,需要新的治疗方法.
- 一种新的肠道酸盐吸收抑制剂Tenapanor为管理高酸血症提供了一种新的机制.
研究的目的:
- 评估tenapanor作为日本血液透析患者PBs的附加疗法的疗效和安全性.
- 为了评估tenapanor提高血清水平的能力,在患者的血清水平高血症不充分控制单独PBs.
主要方法:
- 一项随机的,安慰剂控制的8周研究,涉及169名日本血液透析患者,血清含量在6.1至10.0毫克/分升之间.
- 患者接受了安慰剂加PBS或天帕诺尔加PBS,并增加了天帕诺尔的定位.
- 对血清水平和治疗出现的不良事件进行了监测.
主要成果:
- 在安慰剂组中,tenapanor显著降低了血清含量-2.00 mg/dL,而在安慰剂组中降低了-0.24 mg/dL (P < 0.0001).
- 腹是最常见的不良事件,发生在63.1%的tenapanor组,而安慰剂组的14.1%.
- 所有报告的腹事件都是轻度或中度的严重程度.
结论:
- 当添加到酸盐结合剂时,Tenapanor有效地改善了血液透析患者的血清控制.
- 在现有的PB疗法中添加tenapanor并没有引发新的安全问题.
- 帕诺尔代表了对常规PB治疗不耐药的高酸血症患者的有前途的治疗选择.
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