Kwan Jonathan T C, Pratt Raymond D
S. W. Thames Renal and Transplantation Unit, Epsom and St Helier University Hospitals NHS Trust, St Helier Hospital, Carshalton, Surrey, UK.
Curr Med Res Opin. 2007 Feb;23(2):307-11. doi: 10.1185/030079906X162755.
To demonstrate safety and efficacy of epoetin delta for the management of anaemia in predialysis patients with chronic kidney disease (CKD).
This was a multicentre, open-label, uncontrolled study with predialysis CKD patients who had previously received subcutaneous epoetin therapy. Patients were switched to epoetin delta from their previous therapy, at an identical dose. Dose was subsequently titrated to maintain haemoglobin at 10.0-12.0 g/dL. Study duration was 52 weeks.
The primary endpoint was average haemoglobin levels over Weeks 12, 16, 20 and 24. Secondary analyses were performed on the proportion of patients with haemoglobin and haematocrit levels over preset target levels, haemoglobin and haematocrit levels through to study end and dosing levels.
Haemoglobin levels were maintained at 11.3 +/- 1.2 g/dL over Weeks 12-24. Over 80% of the haemoglobin measurements and 95% of the haematocrit measurements were above the predefined target level (haemoglobin > or = 10 g/dL; haematocrit > or = 30%). Weekly dose levels did not change significantly over the course of the trial. Epoetin delta was well tolerated, with adverse events occurring at frequencies expected for this patient population; no patient developed neutralizing anti-erythropoietin antibodies.
Epoetin delta was an effective and well-tolerated agent for the management of anaemia in a subgroup of predialysis CKD patients.
证明δ-促红细胞生成素用于治疗慢性肾脏病（CKD）透析前患者贫血的安全性和有效性。
这是一项多中心、开放标签、非对照研究，研究对象为曾接受皮下促红细胞生成素治疗的CKD透析前患者。患者从先前治疗改用相同剂量的δ-促红细胞生成素。随后调整剂量以维持血红蛋白水平在10.0 - 12.0 g/dL。研究持续时间为52周。
主要终点是第12、16、20和24周的平均血红蛋白水平。对血红蛋白和血细胞比容水平超过预设目标水平的患者比例、直至研究结束时的血红蛋白和血细胞比容水平以及给药剂量水平进行了次要分析。
在第12 - 24周期间，血红蛋白水平维持在11.3±1.2 g/dL。超过80%的血红蛋白测量值和95%的血细胞比容测量值高于预定义目标水平（血红蛋白≥10 g/dL；血细胞比容≥30%）。在试验过程中，每周给药剂量水平无显著变化。δ-促红细胞生成素耐受性良好，不良事件发生率与该患者群体预期相符；无患者产生中和性抗促红细胞生成素抗体。
对于一部分CKD透析前患者，δ-促红细胞生成素是一种有效且耐受性良好的贫血治疗药物。
