Aarup Michael, Bryndum Julie, Dieperink Hans, Joffe Preben
Department of Nephrology, Odense University Hospital, Denmark.
Nephrol Dial Transplant. 2006 May;21(5):1312-6. doi: 10.1093/ndt/gfk048. Epub 2006 Jan 5.
The erythropoiesis-stimulating protein darbepoetin alfa (Aranesp) can be given intravenously (i.v.) or subcutaneously (s.c.). Despite a s.c. bioavailability of only 37%, darbepoetin alfa i.v. or s.c. dose requirements were comparable in previous studies designed to evaluate other aspects of anaemia treatment. The present study was designed to compare i.v. vs s.c. dose requirements.
A single-centre open-label, prospective and randomized crossover study was undertaken in 71 stable haemodialysis patients. After a run-in period randomized to a 20 week study treatment with either s.c. or i.v. darbepoetin alfa, the patients were crossed over to the other treatment modality for another 20 week study period. The unit dose of weekly darbepoetin alfa was adjusted to maintain each patient's haemoglobin within a target range of -0.8 to +0.8 mmol/l of the individual baseline haemoglobin and between 6.8 and 8.5 mmol/l throughout the study period. The primary endpoint was the mean dose of darbepoetin alfa necessary to maintain the haemoglobin level in the defined range.
Data from 58 patients were available for analysis. Haemoglobin concentrations were maintained effectively in subjects, regardless of whether they received darbepoetin alfa i.v. or s.c.. The overall mean difference in haemoglobin levels during s.c. or i.v. was 0.052 mmol/l (95% confidence interval: -0.132 to 0.236 mmol/l). The difference had no statistical or clinical significance. The population mean darbepoetin alfa dose during i.v. treatment was 32.1 microg/week, compared with a mean value for s.c. treatment of 34.1 microg/week. A paired two-tailed ratio t-test showed that P = 0.036, indicating a 95% probability of a mean dose reduction between 1.2% and 28% by i.v. treatment instead of s.c..
Renal anaemia of stable haemodialysis patients can be treated with darbepoetin alfa more effectively by the i.v. as compared with the s.c. route.
促红细胞生成素刺激蛋白阿法达贝泊汀（Aranesp）可通过静脉注射（i.v.）或皮下注射（s.c.）给药。尽管皮下注射的生物利用度仅为37%，但在以往旨在评估贫血治疗其他方面的研究中，阿法达贝泊汀静脉注射或皮下注射的剂量需求相当。本研究旨在比较静脉注射与皮下注射的剂量需求。
对71例稳定的血液透析患者进行了一项单中心开放标签、前瞻性随机交叉研究。在经过一个导入期后，随机接受皮下或静脉注射阿法达贝泊汀进行为期20周的研究治疗，之后患者交叉接受另一种治疗方式，再进行20周的研究期。每周阿法达贝泊汀的单位剂量进行调整，以在整个研究期间将每位患者的血红蛋白维持在个体基线血红蛋白±0.8 mmol/l的目标范围内，且在6.8至8.5 mmol/l之间。主要终点是将血红蛋白水平维持在规定范围内所需的阿法达贝泊汀平均剂量。
58例患者的数据可用于分析。无论患者接受阿法达贝泊汀静脉注射还是皮下注射，血红蛋白浓度均得到有效维持。皮下注射或静脉注射期间血红蛋白水平的总体平均差异为0.052 mmol/l（95%置信区间：-0.132至0.236 mmol/l）。该差异无统计学或临床意义。静脉注射治疗期间阿法达贝泊汀的总体平均剂量为32.1μg/周，皮下注射治疗的平均值为34.1μg/周。配对双尾比率t检验显示P = 0.036，表明静脉注射治疗比皮下注射治疗平均剂量降低1.2%至28%的概率为95%。
与皮下注射途径相比，静脉注射阿法达贝泊汀能更有效地治疗稳定血液透析患者的肾性贫血。
