An overview of the efficacy and safety of novel erythropoiesis stimulating protein (NESP).
An overview of the efficacy and safety of novel erythropoiesis stimulating protein (NESP).
复制标题
新型红细胞生成刺激蛋白（NESP）的功效和安全性概述。
DOI：
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发表时间：
2001
影响因子：
--
通讯作者：
I. C. Macdougall
中科院分区：
文献类型：
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作者：
I. C. Macdougall
新型促红细胞生成蛋白（NESP，也称为darbepoetin alfa）是一种刺激红细胞生成的分子，其机制与天然和重组人促红细胞生成素（rHuEPO）相同。然而，NESP上额外的唾液残基使其在体内更稳定，消除半衰期延长2至3倍。因此，静脉给药后，NESP的平均消除半衰期为25.3小时，而rHuEPO为8.5小时。皮下给药后，NESP的平均终末半衰期为48.8小时。皮下给药后NESP的平均生物利用度约为37%，与rHuEPO相似。药代动力学数据表明，肾性贫血患者需要更少的NESP剂量比rHuEPO。NESP 0.45微克/公斤，静脉注射或皮下注射每周一次，已被评估用于纠正慢性肾衰竭（CRF）相关贫血。研究人群包括未接受透析的CRF患者，以及接受血液透析或腹膜透析的患者。对于rHuEPO-naïve患者，NESP在纠正贫血方面具有与rHuEPO相似的效果，但给药频率较低。同样，在先前接受rHuEPO治疗的患者中，NESP（无论是静脉注射还是皮下注射）在维持血红蛋白浓度方面与rHuEPO治疗一样有效，如果使用频率降低（即每周一次或每隔一周一次）。NESP耐受性良好，副作用与rHuEPO相似，迄今为止，在暴露于NESP的150例患者中未检测到抗体。
Novel erythropoiesis stimulating protein (NESP, also known as darbepoetin alfa) is a molecule that stimulates erythropoiesis by the same mechanism as both native and recombinant human erythropoietin (rHuEPO). The extra sialic residues on NESP, however, allow it to be more stable in vivo with a 2- to 3-fold longer elimination half-life. Thus, following intravenous administration, the mean elimination half-life of NESP is 25.3 vs 8.5 h for rHuEPO. After subcutaneous administration, the mean terminal half-life for NESP is 48.8 h. The mean bioavailability of NESP after subcutaneous administration is approximately 37%, similar to that reported for rHuEPO. The pharmacokinetic data suggested that patients with renal anaemia would require less frequent dosing with NESP than with rHuEPO. NESP 0.45 microg/kg administered once weekly either intravenously or subcutaneously has been evaluated for the correction of chronic renal failure (CRF)-associated anaemia. The study population included CRF patients not receiving dialysis, along with those on haemodialysis or peritoneal dialysis. In patients who are rHuEPO-naïve, NESP has a similar effect in correcting the anaemia as is seen with rHuEPO, but with less frequent dosing. Similarly, in patients previously receiving rHuEPO, NESP (whether administered intravenously or subcutaneously) is as effective as rHuEPO treatment for maintaining haemoglobin concentration when administered at a reduced frequency (i.e. either once weekly or once every other week). NESP is well tolerated, adverse effects are similar to those seen with rHuEPO, and no antibodies have been detected in >1500 patients exposed to NESP thus far.
影响因子：
158.5
作者：
ESCHBACH, JW;EGRIE, JC;ADAMSON, JW
通讯作者：
ADAMSON, JW