Martínez Castelao A, Reyes A, Valdés F, Otero A, López de Novales E, Pallardó L, Tabernero J M, Hernández Jaras J, Lladós F
Hospital de Bellvitge, Servicio de Nefrología Feixa Llarga, s/n. 08907 Hospitalet de Llobregat, Barcelona.
Nefrologia. 2003;23(2):114-24.
This Spanish single-arm, multicenter, prospective clinical trial assessed the maintenance of hemoglobin concentrations (Hb) between 10-13 g/dL with unit doses of darbepoetin alfa and the safety of the treatment in dialysis patients. Eight-hundred twenty-six patients with chronic renal failure (CRF) (94% receiving haemodialysis and 6% receiving peritoneal dialysis) previously maintained on stable recombinant human erythropoietin (r-HuEPO) therapy with stable hemoglobin (Hb) concentrations (mean Hb concentration = 11.7 g/dL) were switched to darbepoetin alfa at a reduced dosing frequency for 24 weeks (a 20-week titration phase plus a 4-week treatment evaluation phase). Subjects receiving r-HuEPO two or three times weekly were switched to darbepoetin alfa once weekly, and those. who were receiving r-HuEPO once weekly were switched to darbepoetin alfa once every two weeks. The initial dose of darbepoetin alfa was determined from the r-HuEPO dose at inclusion into the study using a formula equating the peptide mass of the two molecules and rounding to the nearest available prefilled syringe dose. Overall, 86.8% of patients completed the 24-weeks of study. Changing the treatment from r-HuEPO to darbepoetin alfa and increasing the dose interval did not result in any clinically significant change in the Hb concentration. From base-line to the evaluation phase, the mean Hb fell 0.09 (95% CI, -0.2; -0.0) g/dl, with an increase of 0.19 (95% CI, 0.0;0.3) g/dL i.v. and a decrease of 0.22 (95% CI, -0.3; -0.1) g/dL s.c.). This maintenance of the mean Hb concentration was accompanied by a mean 9.8% reduction of the darbepoetin alfa dose (19.7% (95% CI, -24.9; -14.2) i.v. and 4.7% (95% CI, -8.5; -0.7) s.c. Treatment with darbepoetin alfa was well tolerated and no unexpected adverse events were reported. In conclusion, the replacement of previous r-HuEPO treatment by darbepoetin alfa in the therapy of anemia secondary to chronic renal failure in diaiyzed patients was effective, well tolerated, and decreased the frequency of dose administration compared with the previous r-HuEPO treatment. Darbepoetin alfa administered once weekly or once every two weeks maintained the baseline Hb levels whilst allowing dose reduction, which was higher in patients receiving i.v. darbepoetin alfa.
这项西班牙单臂、多中心、前瞻性临床试验评估了在透析患者中使用单位剂量的阿法达贝泊汀维持血红蛋白浓度（Hb）在10 - 13 g/dL以及该治疗的安全性。826例慢性肾衰竭（CRF）患者（94%接受血液透析，6%接受腹膜透析），此前接受稳定的重组人促红细胞生成素（r - HuEPO）治疗且血红蛋白（Hb）浓度稳定（平均Hb浓度 = 11.7 g/dL），改为以降低的给药频率使用阿法达贝泊汀24周（20周的滴定阶段加4周的治疗评估阶段）。每周接受两次或三次r - HuEPO治疗的受试者改为每周一次阿法达贝泊汀，而那些每周接受一次r - HuEPO治疗的受试者改为每两周一次阿法达贝泊汀。阿法达贝泊汀的初始剂量根据纳入研究时的r - HuEPO剂量，使用一个将两种分子的肽质量等同并四舍五入到最接近的可用预填充注射器剂量的公式来确定。总体而言，86.8%的患者完成了24周的研究。将治疗从r - HuEPO改为阿法达贝泊汀并延长给药间隔并未导致Hb浓度出现任何具有临床意义的变化。从基线到评估阶段，平均Hb下降了0.09（95%CI， - 0.2； - 0.0）g/dl，静脉注射增加了0.19（95%CI，0.0；0.3）g/dL，皮下注射减少了0.22（95%CI， - 0.3； - 0.1）g/dL。平均Hb浓度的维持伴随着阿法达贝泊汀剂量平均降低9.8%（静脉注射19.7%（95%CI， - 24.9； - 14.2），皮下注射4.7%（95%CI， - 8.5； - 0.7））。阿法达贝泊汀治疗耐受性良好，未报告意外不良事件。总之，在透析患者慢性肾衰竭继发贫血的治疗中，用阿法达贝泊汀替代先前的r - HuEPO治疗是有效的，耐受性良好，并且与先前的r - HuEPO治疗相比降低了给药频率。每周一次或每两周一次给予阿法达贝泊汀可维持基线Hb水平，同时允许减少剂量，接受静脉注射阿法达贝泊汀的患者减少幅度更大。
Wien Klin Wochenschr. 2002-12-30
Can J Kidney Health Dis. 2017-6-30
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