Department of Nephrology, Hôpital de Brabois, CHU, Vandœuvre-lès-Nancy, France.
BMJ Open. 2013 Mar 9;3(3):e001888. doi: 10.1136/bmjopen-2012-001888.
The aim of this study was to describe the management of anaemia with a continuous erythropoietin receptor activator (C.E.R.A., methoxy polyethylene glycol epoetin-β), in patients with chronic kidney disease (CKD) not on dialysis, naïve or non-naïve to treatment with erythropoiesis-stimulating agents (ESAs) at inclusion.
National, multicentre, longitudinal, observational prospective study.
133 nephrologists practicing in France selected patients during their routine follow-up visits. The study was non-interventional.
They were adult CKD patients not on dialysis or kidney transplant patients, naïve or not to ESA treatment: 524 patients not on dialysis (48% ESA-naïve) and 92 kidney transplant patients (24% ESA-naïve) were included and followed up every 3 months during 1 year.
The two main endpoints were the percentage of patients who achieved target haemoglobin (Hb) levels as per European Medicines Agency guidelines (10-12 g/dl) around 6 months of treatment and modalities of treatment.
Approximately one in two patients had an Hb level within 10-12 g/dl at baseline, and around 6 and 12 months of treatment. Ninety per cent of ESA-naïve patients achieved at least +1 g/dl increase over baseline Hb levels or had Hb within 10-12 g/dl around 6 and 12 months. The Hb level remained at approximately 11.5 g/dl during the 12 months of follow-up. Around 6 months: almost all patients were receiving a once-monthly subcutaneous dose of C.E.R.A. (patients not on dialysis: 95±54 µg; kidney transplant patients: 121±70 µg); approximately half the patients did not require a change in C.E.R.A. dose. Adverse effects related to C.E.R.A. were observed in less than 5% of patients and led to modification or discontinuation of treatment in 2%.
The efficacy and safety of C.E.R.A. in CKD patients not on dialysis, with or without kidney transplantation, were confirmed in routine clinical practice.
本研究旨在描述未接受透析的慢性肾脏病（CKD）患者贫血的管理方法，这些患者在纳入时对红细胞生成刺激剂（ESA）治疗为初治或非初治。
全国性、多中心、纵向、观察性前瞻性研究。
133 名在法国执业的肾病学家在常规随访期间选择患者。该研究为非干预性研究。
他们是未接受透析或肾移植的成年 CKD 患者，包括初治或非初治 ESA 治疗的患者：524 名未接受透析的患者（48% ESA 初治）和 92 名肾移植患者（24% ESA 初治），在 1 年内每 3 个月进行随访。
两个主要终点是根据欧洲药品管理局指南（10-12g/dl）在治疗 6 个月左右时达到目标血红蛋白（Hb）水平的患者比例和治疗方式。
大约一半的患者在基线时有 10-12g/dl 的 Hb 水平，在治疗 6 个月和 12 个月左右时也有 10-12g/dl 的 Hb 水平。90%的 ESA 初治患者在基线 Hb 水平上至少增加了 1g/dl，或在治疗 6 个月和 12 个月左右时 Hb 水平达到 10-12g/dl。在 12 个月的随访期间，Hb 水平保持在 11.5g/dl 左右。在治疗 6 个月左右时：几乎所有患者都接受了一次每月的皮下 C.E.R.A.剂量（未接受透析的患者：95±54μg；肾移植患者：121±70μg）；大约一半的患者不需要调整 C.E.R.A.剂量。不到 5%的患者出现与 C.E.R.A.相关的不良反应，导致 2%的患者改变或停止治疗。
在常规临床实践中，证实了 C.E.R.A.在未接受透析的 CKD 患者（包括接受肾移植的患者）中的疗效和安全性。
