[意大利关于慢性透析患者贫血治疗的研究，从人重组促红细胞生成素（rHuEPO）转换为较低剂量的达贝泊汀]

[Italian study on the treatment of anaemia in chronic dialysis patients switched over to less frequent doses of darbepoetin from human recombinant erythropoietin (rHuEPO)].

作者信息

Del Vecchio L, Villa G, Carraro G, Morosetti M, Pedrini L, Adorati Menegato M, Amato M, Mauro M M, Borgatti P, Malberti F, Marai P, Locatelli F

机构信息

Divisione di Nefrologia e Dialisi, Ospedale Alessandro Manzoni, Lecco.

出版信息

G Ital Nefrol. 2004 May-Jun;21(3):259-66.

DOI:

PMID:15285005

Abstract

BACKGROUND

Darbepoetin alpha is a novel erythropoiesis stimulating protein with unique properties as compared to recombinant human erythropoietin (rHuEPO), including a three-fold longer elimination half-life that allows for less frequent dosing. This study was aimed at testing the efficacy and safety of darbepoetin alpha in a large number of chronic dialysis patients switched from rHuEPO.

METHODS

Nine hundred and fifty dialysis patients in stable treatment with rHuEPO were switched to darbepoetin alpha. Patients receiving rHuEPO 2 or 3 times weekly were switched to once weekly darbepoetin alpha and those receiving rHuEPO once weekly were switched to once every other week darbepoetin alpha. Patients received darbepoetin alpha by the same route of administration (SC or IV) as the one used for rHuEPO. The unit doses of darbepoetin alpha (10-150 microg) were titrated to maintain haemoglobin concentration within -1.0 and +1.5 g/dL of the individual mean baseline haemoglobin levels and between 10 and 13 g/dL for 24 weeks.

RESULTS

The mean change in haemoglobin from baseline to the evaluation period (weeks 21-24) was statistically but not clinically significant [-0.10 g/dL (95% CI: -0.18, -0.02]. In general, the geometric mean weekly dose of study drug from screening/baseline to evaluation period remained substantially unmodified [(from 26.10 micro g/wk to 25.90 microg/wk; percentage change -0.40% (95% CI: -3.78, 3.10)]. Overall, darbepoetin alpha was well tolerated.

CONCLUSIONS

The treatment of anaemia of a large dialysis patient population with unit dosing of darbepoetin alpha is effective and safe in maintaining target haemoglobin concentration at reduced dose frequency.

摘要

背景

与重组人促红细胞生成素（rHuEPO）相比，达贝泊汀α是一种具有独特性质的新型促红细胞生成刺激蛋白，其消除半衰期长三倍，给药频率可降低。本研究旨在测试达贝泊汀α在大量从rHuEPO转换过来的慢性透析患者中的疗效和安全性。

方法

950例接受rHuEPO稳定治疗的透析患者转换为使用达贝泊汀α。每周接受2次或3次rHuEPO治疗的患者转换为每周1次达贝泊汀α，每周接受1次rHuEPO治疗的患者转换为每两周1次达贝泊汀α。患者接受达贝泊汀α的给药途径（皮下或静脉注射）与rHuEPO相同。达贝泊汀α的单位剂量（10 - 150微克）进行滴定，以将血红蛋白浓度维持在个体平均基线血红蛋白水平的 -1.0至 +1.5克/分升之间，并在10至13克/分升之间维持24周。

结果

从基线到评估期（第21 - 24周）血红蛋白的平均变化在统计学上有意义，但在临床上无显著意义[-0.10克/分升（95%可信区间：-0.18，-0.02）]。总体而言，从筛查/基线到评估期研究药物的几何平均每周剂量基本未改变[（从26.10微克/周降至25.90微克/周；百分比变化 -0.40%（95%可信区间：-3.78，3.10）]。总体而言，达贝泊汀α耐受性良好。