Barclay P G, Fischer E R, Harris D C
Department of Pharmacy, Westmead Hospital, Australia.
Clin Nephrol. 1993 Nov;40(5):277-80.
Subcutaneous (SC) recombinant human erythropoietin (EPO) has been reported to correct anemia in hemodialysis patients at lower doses than intravenous (IV) EPO. Those trials involved relatively high doses of EPO or did not control adequately for time-related falls in dose requirements. Therefore, on open-label double-crossover study was performed to compare the hemoglobin (Hb) response to low dose SC versus IV EPO. Ten (4 male) maintenance hemodialysis patients previously stabilised on low dose EPO for 18 +/- 3 months (mean +/- SEM) were given EPO IV for 12 weeks (IV#1), then SC for 24 weeks and then IV for a further 20 weeks (IV#2). Iron status and other factors known to modify response to EPO were kept constant. EPO dose was not changed unless Hb rose above 100 g/l, when the dose was reduced to keep Hb between 90 and 100 g/l. Initial EPO dose was 64 +/- 10 u/kg/week. Mean Hb, measured monthly, was not different during the 3 treatment periods. There was wide interpatient variation in the relative response to IV versus SC EPO. Mean Hb was higher on IV EPO in 5 patients (by 6.1 +/- 2.0 g/l) and higher on SC EPO in 5 patients (by 12.1 +/- 4.1 g/l). The difference in mean Hb during IV versus SC administration was more than 5 g/l in 6 patients, being higher in 3 patients during IV administration (by 8.7 +/- 4.6 g/l) and in 3 during SC (by 17.4 +/- 4.6 g/l). In conclusion, the more efficient route of administration of EPO is not predictable for individual patients, and should be sought to allow possible dose reduction.
据报道,皮下注射(SC)重组人促红细胞生成素(EPO)在纠正血液透析患者贫血方面所需剂量低于静脉注射(IV)EPO。以往的试验涉及相对高剂量的EPO,或未充分控制因时间推移导致的剂量需求下降。因此,开展了一项开放标签双交叉研究,以比较低剂量皮下注射与静脉注射EPO时血红蛋白(Hb)的反应。10名(4名男性)维持性血液透析患者此前已接受低剂量EPO稳定治疗18±3个月(均值±标准误),先接受静脉注射EPO 12周(IV#1),然后皮下注射24周,之后再静脉注射20周(IV#2)。铁状态及其他已知会改变对EPO反应的因素保持不变。除非Hb升至100 g/l以上,否则EPO剂量不变,此时将剂量降低以使Hb维持在90至100 g/l之间。初始EPO剂量为64±10 U/kg/周。在3个治疗期内,每月测量的平均Hb无差异。患者对静脉注射与皮下注射EPO的相对反应存在很大个体差异。5名患者静脉注射EPO时平均Hb较高(高6.1±2.0 g/l),5名患者皮下注射EPO时平均Hb较高(高12.1±4.1 g/l)。6名患者静脉注射与皮下注射期间平均Hb差异超过5 g/l,其中3名患者静脉注射时较高(高8.7±4.6 g/l),3名患者皮下注射时较高(高17.4±4.6 g/l)。总之,对于个体患者而言,EPO更有效的给药途径无法预测,应探索以实现可能的剂量降低。