Spinowitz Bruce S, Pratt Raymond D
Department of Nephrology, New York Hospital Queens and Cornell University Medical Center, New York, NY, USA.
Curr Med Res Opin. 2006 Dec;22(12):2507-13. doi: 10.1185/030079906X158048.
To demonstrate the efficacy and safety of epoetin delta for the treatment of anaemia in dialysis patients with chronic kidney disease (CKD).
This was a 12-week, randomized, double-blind, active-comparator study. CKD patients who were naïve to epoetin treatment and had haemoglobin < 10 g/dL were randomized to epoetin delta 15, 50, 150, or 300 IU/kg or epoetin alfa 50 IU/kg. Patients initially entered a correction phase until they recorded haemoglobin of > or = 11.5 g/dL for two consecutive weekly measurements or one haemoglobin measurement of > or = 13 g/dL (correction success). A maintenance phase followed where the dose was adjusted to maintain haemoglobin > or = 10.5 g/dL. Maintenance success was defined as haemoglobin > 10.5 g/dL at Week 12. Total success was defined as achieving maintenance and correction success.
The primary objective was to demonstrate that the proportion of patients achieving total success was greater in the pooled 150 IU/kg and 300 IU/kg groups compared with the 15 IU/kg dose group.
Total success was achieved in 55.6% of patients in the pooled highest epoetin delta group compared with 4.5% in the lowest dose group. There was no significant difference in total success for the epoetin delta and epoetin alfa 50 IU/kg groups. Significant increases in haemoglobin and haematocrit levels were observed in the 150 and 300 IU/kg dose groups. Adverse events occurred at frequencies expected for this patient group.
Epoetin delta was effective in increasing haemoglobin levels in patients with baseline haemoglobin of < 10 g/dL.
证明聚乙二醇化重组人促红细胞生成素δ治疗慢性肾脏病（CKD）透析患者贫血的有效性和安全性。
这是一项为期12周的随机、双盲、活性对照研究。既往未接受过促红细胞生成素治疗且血红蛋白<10 g/dL的CKD患者被随机分为聚乙二醇化重组人促红细胞生成素δ 15、50、150或300 IU/kg组或促红细胞生成素α 50 IU/kg组。患者最初进入校正期，直至连续两次每周测量的血红蛋白≥11.5 g/dL或一次血红蛋白测量≥13 g/dL（校正成功）。随后进入维持期，调整剂量以维持血红蛋白≥10.5 g/dL。维持成功定义为第12周时血红蛋白>10.5 g/dL。总成功定义为实现维持成功和校正成功。
主要目的是证明合并的150 IU/kg和300 IU/kg组中实现总成功的患者比例高于15 IU/kg剂量组。
合并的最高剂量聚乙二醇化重组人促红细胞生成素δ组中55.6%的患者实现了总成功，而最低剂量组为4.5%。聚乙二醇化重组人促红细胞生成素δ组和促红细胞生成素α 50 IU/kg组在总成功方面无显著差异。150和300 IU/kg剂量组的血红蛋白和血细胞比容水平显著升高。不良事件的发生频率为本患者群体的预期频率。
聚乙二醇化重组人促红细胞生成素δ可有效提高基线血红蛋白<10 g/dL患者的血红蛋白水平。
