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达比泊汀α对重组人促红细胞生成素(rHuEpo)抵抗的血液透析患者的疗效。

The efficacy of darbepoetin alpha in hemodialysis patients resistant to human recombinant erythropoietin (rHuEpo).

作者信息

Hejaili Fayez

机构信息

Department of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia, Saudi Arabia.

出版信息

Saudi J Kidney Dis Transpl. 2009 Jul;20(4):590-5.

PMID:19587498
Abstract

Darbepoetin due to longer half life is convenient and effective for long term. This study was done to assess the efficacy of darbepoetin in the treatment of patients on high doses of erythropoietin (EPO) and to compare its efficacy in patients resistant and responsive to EPO. This is a prospective, controlled open label study assessing the efficacy of darbepoetin in 55 hemodialysis patients on high dose EPO and comparing its efficacy in the patients who were "EPO -resistant" (group 1, n= 28) and in those who were "EPO-responsive" (group 2, n= 27). The initial conversion ratio was 380 mcg darbepoetin: 1 U EPO/ week and the dose of darbepoetin was adjusted thereafter at fortnightly intervals with the aim of achieving and maintaining the hemoglobin level between 11-12 g/dL. The patients were followed up for 12 weeks following the introduction of darbepoetin. The impact of gender, baseline PTH, age, Kt/V, duration on dialysis, initial EPO dose on the response to darbepoetin was investigated. Continuous variables were compared using two tailed t-test and non-parametric by Fisher exact test. Overall darbepoetin was effective with 85.5 % of the patients responding and 21.8 % of the patients' able to maintain their hemoglobin with once fortnightly dose by the end of the study. Mean darbepoetin dose and the mean EPO to darbepoetin conversion ratio on completion of the study were 58.2 (42.4) mcg/week (0.983 (0.87) mcg/kg/week) and 384:1 respectively. Hemoglobin levels in groups 1 improved from 9.8 +/- 0.9 g/dL to 12.0 +/- 1.4 g/dL (0.0001) and 2 were and maintained it in group 2 at 11.9 +/- 1.3 g/dL (P= 0.79). The doses of darbepoetin required in groups 1 and 2 were similar (54.3 +/- 33 and 53.9 +/- 47 mcg/week (P= 0.97) respectively and 0.89 +/- 0.6 and 0.98 +/- 1.0 mcg/kg/week (P= 0.8). 22 (78.6 %) of the EPO resistant patients responded to darbepoetin. In conclusion conversion from high dose EPO to darbepoetin proved successful even in patients who were resistant to EPO. The darbepoetin dose required in the EPO resistant and EPO responsive groups did not differ significantly and age, duration on dialysis and baseline PTH level had no impact on responsiveness to EPO or darbepoetin.

摘要

由于半衰期较长,达贝泊汀长期使用方便且有效。本研究旨在评估达贝泊汀治疗高剂量促红细胞生成素(EPO)患者的疗效,并比较其在EPO抵抗和敏感患者中的疗效。这是一项前瞻性、对照开放标签研究,评估达贝泊汀对55例接受高剂量EPO的血液透析患者的疗效,并比较其在“EPO抵抗”组(第1组,n = 28)和“EPO敏感”组(第2组,n = 27)患者中的疗效。初始转换率为380 mcg达贝泊汀:1 U EPO/周,此后每两周调整一次达贝泊汀剂量,目标是使血红蛋白水平达到并维持在11 - 12 g/dL。引入达贝泊汀后对患者进行了12周的随访。研究了性别、基线甲状旁腺激素(PTH)、年龄、Kt/V、透析时间、初始EPO剂量对达贝泊汀反应的影响。连续变量采用双尾t检验进行比较,非参数变量采用Fisher精确检验。总体而言,达贝泊汀有效,85.5%的患者有反应,21.8%的患者在研究结束时能够每两周一次剂量维持血红蛋白水平。研究完成时,达贝泊汀的平均剂量和EPO与达贝泊汀的平均转换率分别为58.2(42.4)mcg/周(0.983(0.87)mcg/kg/周)和384:1。第1组血红蛋白水平从9.8±0.9 g/dL提高到12.0±1.4 g/dL(P = 0.0001),第2组维持在11.9±1.3 g/dL(P = 0.79)。第1组和第2组所需的达贝泊汀剂量相似(分别为54.3±33和53.9±47 mcg/周(P = 0.97)以及0.89±0.6和0.98±1.0 mcg/kg/周(P = 0.8))。22例(78.6%)EPO抵抗患者对达贝泊汀有反应。总之,即使在EPO抵抗的患者中,从高剂量EPO转换为达贝泊汀也被证明是成功的。EPO抵抗组和EPO敏感组所需的达贝泊汀剂量没有显著差异,年龄、透析时间和基线PTH水平对EPO或达贝泊汀的反应性没有影响。

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引用本文的文献

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Advancing Anemia Management in Chronic Kidney Disease: Assessing the Superiority of Darbepoetin Alfa Over Erythropoietin Alpha.推进慢性肾脏病贫血管理:评估达贝泊汀α相对于促红细胞生成素α的优越性。
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