用于治疗透析患者贫血的佩格莫莱沙:一项随机临床试验
Ping Zhang1, Yan Jiang1, Chunping Xu1
1Kidney Disease Center, The First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou, China.
EClinicalMedicine
|November 13, 2023
概括
对透析患者的新型贫血治疗药物佩格莫莱沙提德与阿尔法时一样有效和安全. 这种长效受体激动剂为慢性病贫血提供了方便的每月注射选择.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 药理学 药理学是指药理学的学科.
背景情况:
- 贫血是慢性病 (CKD) 的常见并发症.
- 红色素形成刺激剂 (ESA),如阿尔法乙,用于治疗透析患者的贫血.
- 需要具有长期作用的,具有成本效益的ESA,而无需对抗体生产的担忧.
研究的目的:
- 为了评估与阿尔法乙相比莫利沙的疗效和安全性,在中国有贫血的透析患者中.
- 为了确定佩格莫利沙提德与阿尔法乙对维持血红蛋白水平的不劣.
主要方法:
- 一个随机的,开放的,积极的比较者,非劣势的第三阶段试验.
- 2019年5月至2022年3月,中国有43个透析中心.
- 372名患者 (18-70岁) 随机 (2:1) 分给佩格莫莱沙 (每月一次) 或阿尔法乙 (每周1-3次).
- 剂量调整以维持血红蛋白10.012.0 g/dL.
- 主要终点:在每一协议组 (PPS) 中血红蛋白的平均变化.
主要成果:
- 佩格莫利沙提德证明与阿尔法乙烯无劣势 (平均血红蛋白变化:0.07与-0.22g/dL;差异:0.29g/dL [95%CI:0.110.47]).
- 在 pegmolesatide 接受者中,有 94% 的患者和在 epoetin alfa 接受者中,有 89% 的患者发生了不良事件.
- 高血压是最常见的相关不良事件;没有报告致命的过敏反应或低血压.
结论:
- 每月皮下注射佩格莫利沙提德是有效和安全的治疗贫血在中国透析患者.
- 佩格莫利沙提德提供了与传统的阿尔法时乙烯相似的替代品,使用频率较低.
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