一项比较每周一次、每两周一次和每四周一次给予促红细胞生成素α治疗慢性肾脏病贫血患者的随机对照研究。

A randomized controlled study comparing once-weekly to every-2-week and every-4-week dosing of epoetin alfa in CKD patients with anemia.

机构信息

Renal Associates PA, 215 East Quincy Street, Suite 610, San Antonio, TX 78215, USA.

出版信息

Clin J Am Soc Nephrol. 2010 Apr;5(4):598-606. doi: 10.2215/CJN.06770909. Epub 2010 Feb 25.

DOI:10.2215/CJN.06770909

PMID:20185602

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2849701/

Abstract

BACKGROUND AND OBJECTIVES

Extended-interval dosing of epoetin alfa (EPO) is commonly used to treat anemia in patients with chronic kidney disease (CKD). This study aimed to demonstrate that EPO dosed every 2 weeks (Q2W) and every 4 weeks (Q4W) was noninferior to once-weekly (QW) dosing.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: 430 anemic subjects with stage 3 to 4 CKD receiving a stable QW dose of EPO were randomized 1:1:2 to QW, Q2W, and Q4W dosing for 36 weeks. Hemoglobin (Hb) was measured weekly, and the dose of EPO was adjusted to maintain an Hb level of 11.0 to 11.9 g/dl. The primary endpoint was change in Hb from baseline to the average of the last 12 weeks of treatment.

RESULTS

Both the Q2W and Q4W dosing groups were noninferior to the QW group. The estimated difference of the mean change in Hb between Q2W and QW was -0.03 g/dl; and between Q4W and QW was -0.09 g/dl. From weeks 13 to 37, the mean percentage of weeks per subject with Hb 10.0 to 11.9 g/dl, inclusive, was 81% for QW, 81% for Q2W, and 75% for Q4W. Death occurred, respectively, in 4%, 3%, and 4%; thromboembolic vascular events occurred in 3%, 5%, and 3%; and serious adverse events occurred in 22%, 26%, and 26% of subjects.

CONCLUSIONS

Q2W and Q4W EPO dosing maintained Hb levels in subjects with stage 3 to 4 CKD. Deaths, thromboembolic vascular events, and serious adverse events were comparable across the dosing groups.

摘要

背景与目的

延长间隔时间给予促红细胞生成素（EPO）治疗常用于治疗慢性肾脏病（CKD）患者的贫血。本研究旨在证明 EPO 每 2 周（Q2W）和每 4 周（Q4W）给药与每周一次（QW）给药相比不劣效。

设计、地点、参与者和测量方法：430 名患有 3 至 4 期 CKD 的贫血患者接受稳定的 QW 剂量 EPO 治疗，随机分为 1:1:2 组，分别接受 QW、Q2W 和 Q4W 治疗，共 36 周。每周测量血红蛋白（Hb），调整 EPO 剂量以维持 Hb 水平在 11.0 至 11.9g/dl。主要终点是从基线到治疗最后 12 周的平均 Hb 变化。

结果

Q2W 和 Q4W 给药组均不劣于 QW 组。估计 Q2W 与 QW 组之间 Hb 平均变化的差值为-0.03g/dl；Q4W 与 QW 组之间的差值为-0.09g/dl。从第 13 周到第 37 周，每周 Hb 为 10.0 至 11.9g/dl 的受试者所占的平均比例分别为 QW 组为 81%、Q2W 组为 81%、Q4W 组为 75%。死亡分别发生在 4%、3%和 4%的患者中；血栓栓塞性血管事件分别发生在 3%、5%和 3%的患者中；严重不良事件分别发生在 22%、26%和 26%的患者中。