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在中国的ESRD患者中,Tenapanor在血液透析中患有高酸血症:一个随机的第三阶段试验

Liangying Gan¹, Li Xing², Yan Xu³

¹Department of Nephrology, Peking University People's Hospital, Beijing, China.

Clinical kidney journal

|January 8, 2024

概括

在接受血液透析的中国患者中,Tenapanor有效降低了血清酸盐水平,患者患有末期脏疾病. 这项研究证实了tenapanor的存在.

科学领域:

腎臟病學 (nephrology) 是一種醫學.
临床药理学临床药理学

背景情况:

超酸血是末期病 (ESRD) 患者接受血液透析 (HD) 的常见并发症.
在中国的ESRD患者中,天帕诺尔治疗高酸性血症的疗效和安全性以前未得到证实.

研究的目的:

评估特纳帕诺尔在中国成年患者的疗效和安全性,ESRD在HD和高酸血症.

主要方法:

一项随机,双盲,安慰剂控制的第三期试验在中国的26个透析设施中进行.
患有ESRD的成年患者在HD和高酸血症被随机分配 (1:1) 接受口服天巴诺尔30毫克每天两次或安慰剂4周3周的洗期后4周.
主要终点是从基线到终点访问 (第29天) 的平均血清水平的变化.

主要成果:

与安慰剂相比,帕诺治疗 (n=75) 导致血清酸盐显著减少 (n=72):LS平均差异为-1.17 mg/dL (P < .001).
在接受天巴诺的患者中,更高比例的患者在终点检查时达到血清水平<5.5 mg/dL (44.6%与10.1%相比).
最常见的与治疗相关的不良事件是腹,它大多是轻微的,导致仅在两名患者中断治疗.

结论:

与安慰剂相比,帕诺在中国患者中显著降低了血清水平,患有HD的ESRD.
在这个患者群体中,Tenapanor通常被很好地容忍.

关键词:

透析是通过透析进行的.最终阶段的脏疾病.过高酸盐血症的发生./交换器异型3 型十一十一十一十一十一十一

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