Molina M, García Hernández M A, Navarro M J, De Gracia M C, Ortuño T
Servicio de Nefrología, Hospital Santa María del Rosell, Cartagena.
Nefrologia. 2004;24(6):564-71.
This prospective, two-arm, clinical trial assesses the effectiveness in maintaining the levels of haemoglobin (Hb) between 11 and 13 g/d1 and the safety of changing the administration route (from subcutaneous to intravenous) of epoetin (rHuEPO) alpha at equidose versus a changeover to darbepoetin alpha, taking the exact equivalence in peptide mass between the two as referent in patients with chronic renal insufficiency (CRI) in haemodialysis. A total of 112 patients previously treated with epoetin and no dose modification during the 8 weeks prior to the study and stable levels of Hb were included. Of these, 92.1% finished the follow-up period (24 weeks). After changing the administration route of rHuEPO, a significant increase in the resistance index (REI, weekly dose per kilogram of weight/levels of hemoglobin) was observed with mean values of 2.73 (p < 0.018) and 4.37 (p < 0.001) after 16 and 24 weeks respectively, requiring an increase of the dose greater than 15% over the baseline in 6 1.1% of the patients. The changeover to, darbepoetin alpha, independently of the administration route, was accompanied by a decrease in REI starting in the 8th week (mean levels of 0.012, 0.018 and 0.023 after 8, 16 and 24 weeks respectively), significant (p < 0.001) at the 3 cutoff points of the study. The conversion factor increased significantly up to 1:260 in week 24. Both erythropoietic stimulating factors (EST) were well tolerated and no unexpected side effects were observed. In conclusion, treatment of anaemia with darbepoetin alpha in patients with CRI in haemodialysis previously treated with rHuEPO proved to be more effective than the use of epoetin intravenously, significantly improving the resistance index. In addition, the treatment with darbepoetin alpha was well tolerated in these patients.
这项前瞻性双臂临床试验评估了在维持血红蛋白（Hb）水平在11至13g/d1之间的有效性，以及在慢性肾功能不全（CRI）血液透析患者中，将等量的促红细胞生成素（rHuEPO）α的给药途径（从皮下改为静脉内）与换成达贝泊汀α相比的安全性，以两者之间肽质量的精确等效性为参考。共纳入112名先前接受促红细胞生成素治疗、在研究前8周内未进行剂量调整且Hb水平稳定的患者。其中，92.1%完成了随访期（24周）。在改变rHuEPO的给药途径后，观察到抵抗指数（REI，每周每千克体重剂量/血红蛋白水平）显著增加，16周和24周后的平均值分别为2.73（p<0.018）和4.37（p<0.001），61.1%的患者需要将剂量比基线增加超过15%。换成达贝泊汀α，无论给药途径如何，从第8周开始REI下降（8周、16周和24周后的平均水平分别为0.012、0.018和0.023），在研究的3个时间点均有显著差异（p<0.001）。转换因子在第24周显著增加至1:260。两种促红细胞生成刺激因子（EST）耐受性良好，未观察到意外副作用。总之，在先前接受rHuEPO治疗的CRI血液透析患者中，用达贝泊汀α治疗贫血比静脉使用促红细胞生成素更有效，显著改善了抵抗指数。此外，这些患者对达贝泊汀α治疗耐受性良好。
