Department of Nephrology and Rheumatology, Tosei General Hospital, Seto, Aichi 489-8642, Japan.
Clin Exp Nephrol. 2010 Apr;14(2):158-63. doi: 10.1007/s10157-009-0251-x. Epub 2009 Dec 5.
Darbepoetin alfa, which has a much longer half-life than recombinant human erythropoietin, is used to treat renal anemia. However, there are few reports investigating the efficacy of darbepoetin alfa administered every 2 weeks (Q2W).
We performed the single-center, prospective, and randomized study in chronic hemodialysis patients. Clinically stable patients on hemodialysis were recruited, and darbepoetin alfa 15-40 microg/week was administered intravenously once a week (QW) to achieve a hemoglobin (Hb) level of 10.5-12.0 g/dl for 8 weeks prior to randomization. The patients were randomly assigned to 2 different dosing frequency groups: once a week (QW) or every 2 weeks (Q2W). We switched to a double dose in the Q2W group. We measured Hb level every 2 weeks and administered darbepoetin alfa to achieve an Hb level of 10.5-11.5 g/dl. The primary endpoints were the weekly dose of darbepoetin alfa administered at week 24.
We assigned 19 and 20 patients into QW and Q2W, respectively. There were no significant differences between the groups in Hb, transferrin saturation, ferritin, and weekly dose of darbepoetin alfa at end of the baseline period. There was no significant difference in Hb level at week 24, at which time the weekly dose requirement and dose per dry body weight were much higher in the Q2W than in the QW group.
Administration of darbepoetin alfa Q2W could maintain Hb level similarly to to that obtained QW, but we did not confirm efficiency at a higher dose requirement or blood pressure elevation.
达贝泊汀阿尔法的半衰期比重组人促红细胞生成素长得多,用于治疗肾性贫血。然而,很少有研究报告调查每 2 周(Q2W)给予达贝泊汀阿尔法的疗效。
我们在慢性血液透析患者中进行了单中心、前瞻性、随机研究。招募接受血液透析且临床稳定的患者,在随机分组前的 8 周内每周静脉注射一次达贝泊汀阿尔法 15-40μg/周,以将血红蛋白(Hb)水平维持在 10.5-12.0g/dl。患者被随机分配到 2 个不同的给药频率组:每周一次(QW)或每 2 周一次(Q2W)。我们在 Q2W 组中增加至双倍剂量。我们每 2 周测量一次 Hb 水平,并给予达贝泊汀阿尔法以使 Hb 水平达到 10.5-11.5g/dl。主要终点是第 24 周时给予的达贝泊汀阿尔法的每周剂量。
我们分别将 19 名和 20 名患者分配到 QW 和 Q2W 组。在基线期末,两组之间的 Hb、转铁蛋白饱和度、铁蛋白和达贝泊汀阿尔法的每周剂量均无显著差异。第 24 周时 Hb 水平无显著差异,此时 Q2W 组的 Hb 水平要求和每干体重剂量均明显高于 QW 组。
给予达贝泊汀阿尔法 Q2W 可以类似地维持 Hb 水平,但我们并未确认在更高剂量需求或血压升高时的疗效。