JAMA Intern Med:口服Daprodustat方案治疗慢性肾病贫血

2022-04-06 zhangfan MedSci原创

Daprodustat对慢性肾病贫血患者的治疗效果与阿法达贝泊相当,是一种有效地口服促红细胞生成治疗方案。

统计发现,开始透析后的前90天,患者死亡风险是随后9个月的2倍。新透析患者需经历一系列生理和心理变化,包括尿毒症介质清除引起的代谢流量变化、贫血纠正、代谢性骨病参数变化、血压和细胞外容积变化,部分患者还有炎症加重和营养不良的现象。贫血是慢性肾病患者的常见并发症,通常需接受促红细胞生成剂注射治疗。近日研究人员考察了口服缺氧诱导因子脯氨酰羟化酶抑制剂Daprodustat对新近CKD透析贫血患者的疗效。

本次研究在14个国家的90个临床中心开展,在研究开始前90天开始接受血液透析(HD)或腹膜透析(PD)的晚期CKD患者参与,患者血红蛋白(Hb)浓度8.0-11.0g/dL,随机接受Daprodustat 或阿法达贝泊(Darbepoetin alfa)治疗。研究的主要终点是评估期(28-52周后)HD水平,次要终点是平均每月铁剂静脉注射剂量变化。

312名患者参与研究,平均年龄55岁,男性占62%,其中157人接受Daprodustat 治疗,155人接受阿法达贝泊治疗,306人(98%)完成研究。Daprodustat组评估期HD浓度为10.5g/dL,阿法达贝泊组为10.6g/dL,达到非劣性。各组52周时,平均每月铁剂静脉注射剂量均降低,但daprodustat组无显著优势(调整后平均差异19.4mg)。Daprodustat组不良事件率为76%,阿法达贝泊组为72%。

组间HD水平及铁注射量变化

研究认为,Daprodustat对慢性肾病贫血患者的治疗效果与阿法达贝泊相当,是一种有效地口服促红细胞生成治疗方案。

原始出处:

Ajay K. Singh et al. Efficacy and Safety of Daprodustat for Treatment of Anemia of Chronic Kidney Disease in Incident Dialysis Patients A Randomized Clinical Trial. JAMA Intern Med, April 4, 2022.

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    2022-04-08 sunylz
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    2022-04-06 肿瘤克星

    JAMA上文章都是顶级的,谢谢梅斯及时上新

    0

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    2022-04-06 医者仁者

    Daprodustat可惜FDA不批准上市#贫血#,它的血栓风险始终未能解释清楚。

    0

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