Smith R E, Jaiyesimi I A, Meza L A, Tchekmedyian N S, Chan D, Griffith H, Brosman S, Bukowski R, Murdoch M, Rarick M, Saven A, Colowick A B, Fleishman A, Gayko U, Glaspy J
South Carolina Oncology Associates, Suite IA, 1301 Taylor, Columbia, SC 29201, USA.
Br J Cancer. 2001 Apr;84 Suppl 1(Suppl 1):24-30. doi: 10.1054/bjoc.2001.1749.
Anaemia is a common haematologic disorder in patients with cancer and has a multifactorial aetiology, including the effects of the malignancy itself and residual effects from previous therapy. Novel erythropoiesis stimulating protein (NESP, darbepoetin alfa), a protein with additional sialic acid compared with erythropoietin (EPO), stimulates erythropoiesis by the same mechanism as recombinant human erythropoietin (rHuEPO) but it is biochemically distinct. NESP, with its approximately 3-fold greater serum half-life, can maintain haemoglobin levels as effectively as rHuEPO in anaemic patients with chronic renal failure and do so with less frequent dosing. We investigated the ability of NESP to safely increase haemoglobin levels of anaemic patients with non-myeloid malignancies not receiving chemotherapy. NESP was administered under the supervision of a physician at doses of 0.5, 1.0, 2.25 or 4.5 mcg kg(-1)wk(-1)for a maximum of 12 weeks. This report includes 89 patients completing the study by November 2000. NESP was well tolerated, with no reported dose-limiting toxicities or treatment-related severe adverse events. Increasing doses of NESP corresponded with increased efficacy. The percentage (95% confidence interval) of patients responding ranged from 61% (42%, 77%) in the 1.0 mcg kg(-1)wk(-1)group to 83% (65%, 94%) in the 4.5 mcg kg(-1)wk(-1)group.
贫血是癌症患者常见的血液系统疾病，其病因是多因素的，包括恶性肿瘤本身的影响以及既往治疗的残留影响。新型促红细胞生成素（NESP，达贝泊汀α）是一种比促红细胞生成素（EPO）多含唾液酸的蛋白质，它通过与重组人促红细胞生成素（rHuEPO）相同的机制刺激红细胞生成，但在生化性质上有所不同。NESP的血清半衰期约为rHuEPO的3倍，在慢性肾衰竭贫血患者中，它能以与rHuEPO同样有效的方式维持血红蛋白水平，且给药频率更低。我们研究了NESP安全提高未接受化疗的非髓系恶性肿瘤贫血患者血红蛋白水平的能力。NESP在医生监督下以0.5、1.0、2.25或4.5 mcg·kg⁻¹·wk⁻¹的剂量给药，最长给药12周。本报告纳入了截至2000年11月完成研究的89例患者。NESP耐受性良好，未报告剂量限制性毒性或与治疗相关的严重不良事件。NESP剂量增加，疗效相应提高。有反应患者的百分比（95%置信区间）在1.0 mcg·kg⁻¹·wk⁻¹组为61%（42%，77%），在4.5 mcg·kg⁻¹·wk⁻¹组为83%（65%，94%）。
