Bommer Juergen, Asmus Gernot, Wenning Martin, Bommer Gudrun
Medical Clinic, University of Heidelberg, Heidelberg, Germany.
Nephrol Dial Transplant. 2008 Dec;23(12):4002-8. doi: 10.1093/ndt/gfn416. Epub 2008 Jul 30.
The different efficacy of subcutaneous and intravenous rHuEPO results in higher doses and costs in intravenously treated patients. Darbepoetin alfa has a different pharmacokinetic profile compared to rHuEPO, and previous clinical experience suggests that subcutaneous and intravenous darbepoetin alfa may have similar efficacy. Objective. The aim of this study was to compare the efficacy of intravenous and subcutaneous darbepoetin alfa regarding haemoglobin levels and doses.
Patients treated with subcutaneous darbepoetin alfa for at least 6 months were randomized 1:1 to continue with subcutaneous treatment of darbepoetin alfa or to switch to the intravenous administration route. The application frequency was not altered. Darbepoetin alfa dose as well as haemoglobin concentrations were evaluated as per patient average at baseline (Week -3 +/- 1), Week 24 +/- 3 and Week 48 +/- 3.
One hundred fourteen patients in 9 German dialysis centres were included. Fifty-three patients were treated intravenously and 61 patients continued the subcutaneous therapy. Mean haemoglobin levels and mean weekly darbepoetin alfa dose did not change significantly in either treatment group.
Our data suggest that the darbepoetin alfa dose can be kept constant if patients are switched from subcutaneous to intravenous treatment.
皮下注射和静脉注射重组人促红细胞生成素（rHuEPO）的疗效不同，导致静脉治疗患者的用药剂量更高且成本更高。与rHuEPO相比，阿法达贝泊汀具有不同的药代动力学特征，既往临床经验表明皮下注射和静脉注射阿法达贝泊汀可能具有相似的疗效。目的。本研究旨在比较静脉注射和皮下注射阿法达贝泊汀在血红蛋白水平和剂量方面的疗效。
接受皮下注射阿法达贝泊汀治疗至少6个月的患者按1:1随机分组，继续皮下注射阿法达贝泊汀治疗或改为静脉给药途径。应用频率不变。根据患者在基线（第-3±1周）、第24±3周和第48±3周的平均值评估阿法达贝泊汀剂量以及血红蛋白浓度。
纳入了德国9个透析中心的114例患者。53例患者接受静脉治疗且61例患者继续皮下治疗。两个治疗组的平均血红蛋白水平和平均每周阿法达贝泊汀剂量均无显著变化。
我们的数据表明，如果患者从皮下治疗改为静脉治疗，阿法达贝泊汀剂量可以保持不变。
