一项针对未接受透析的慢性肾脏病患者使用阿法依泊汀延长给药方案（每2周一次或每月一次）的观察性队列研究：EXTEND研究。

An observational cohort study of extended dosing (once every 2 weeks or once monthly) regimens with darbepoetin alfa in patients with chronic kidney disease not on dialysis: the EXTEND study.

作者信息

Galle Jan-Christoph, Claes Kathleen, Kiss Istvan, Winearls Christopher G, Herlitz Hans, Guerin Alain, Di Giulio Salvatore, Suranyi Michael G, Bridges Ian, Addison Janet, Farouk Mourad

机构信息

Klinik für Nephrologie und Dialyseverfahren, Klinikum Lüdenscheid, Lüdenscheid, Germany.

出版信息

Nephrol Dial Transplant. 2012 Jun;27(6):2303-11. doi: 10.1093/ndt/gfr677. Epub 2011 Dec 2.

DOI:10.1093/ndt/gfr677

PMID:22140136

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3363980/

Abstract

BACKGROUND

Darbepoetin alfa (DA) has been shown to be an effective treatment of anaemia in patients with chronic kidney disease (CKD) not on dialysis (NoD). EXTEND is an observational study assessing the effectiveness of DA administered once biweekly (Q2W) or monthly (QM) in a general CKD-NoD population.

METHODS

Adult CKD-NoD patients starting DA Q2W/QM treatment in June 2006 or later were eligible. Retrospective and/or prospective data including haemoglobin levels and erythropoiesis-stimulating agent (ESA) dosing were collected for 6 months before and 12 months after DA initiation. Mean Hb levels were calculated every 3 months, and ESA dose was converted to a geometric mean weekly DA equivalent dose and summarized monthly.

RESULTS

Data from 4278 patients showed that patients receiving ESA treatment before DA Q2W/QM initiation had a mean (95% confidence interval) Hb level of 11.9 g/dL (11.8-12.0 g/dL) at initiation and 11.6 g/dL (11.6-11.7 g/dL) at Months 10-12, with mean ESA dose of 22 μg/week (21-23 μg/week) prior to initiation, 16 μg/week (15-16 μg/week) at initiation and 16 μg/week (15-16 μg/week) at Month 12. In ESA-naive patients, Hb levels increased from 10.3 g/dL (10.2-10.3 g/dL) at initiation to 11.7 g/dL at Months 4-6 and were maintained at a mean level of 11.7 g/dL (11.7-11.8 g/dL) at Months 10-12, with mean ESA dose of 16 μg/week (16-17 μg/week) at initiation and 16 μg/week (16-17 μg/week) at Month 12. In the 85% of patients receiving DA at extended intervals (Q2W or less frequently) at Month 12, 12 patients (0.3%) experienced DA-related adverse reactions.

CONCLUSION

DA Q2W/QM was an effective treatment of anaemia in the general CKD-NoD patient population and a dose increase was not required in patients switching from a previous ESA regimen.

摘要

背景

已证明，对于未接受透析治疗的慢性肾脏病（CKD）患者，阿法依泊汀（DA）是一种有效的贫血治疗药物。EXTEND是一项观察性研究，旨在评估在一般CKD未透析患者群体中每两周（Q2W）或每月（QM）给药一次的DA的有效性。

方法

2006年6月或之后开始Q2W/QM治疗DA的成年CKD未透析患者符合条件。收集DA开始前6个月和开始后12个月的回顾性和/或前瞻性数据，包括血红蛋白水平和促红细胞生成素（ESA）剂量。每3个月计算平均血红蛋白水平，将ESA剂量转换为几何平均每周DA等效剂量并每月汇总。

结果

4278例患者的数据显示，在开始Q2W/QM DA治疗前接受ESA治疗的患者，开始时平均（95%置信区间）血红蛋白水平为11.9 g/dL（11.8 - 12.0 g/dL），在第10 - 12个月时为11.6 g/dL（11.6 - 11.7 g/dL），开始前平均ESA剂量为22 μg/周（21 - 23 μg/周），开始时为16 μg/周（15 - 16 μg/周），第12个月时为16 μg/周（15 - 16 μg/周）。在未接受过ESA治疗的患者中，血红蛋白水平从开始时的10.3 g/dL（10.2 - 10.3 g/dL）增加到第4 - 6个月时的11.7 g/dL，并在第10 - 12个月时维持在平均水平11.7 g/dL（11.7 - 11.8 g/dL），开始时平均ESA剂量为16 μg/周（16 - 17 μg/周），第12个月时为16 μg/周（16 - 17 μg/周）。在第12个月以延长间隔（Q2W或更低频率）接受DA治疗的85%的患者中，12例患者（0.3%）出现与DA相关的不良反应。