Justice G, Kessler J F, Jadeja J, Campos L, Weick J, Chen C-F, Heatherington A C, Amado R G
Pacific Coast Hematology Oncology Medical Group, Fountain Valley, CA 92708, USA.
Ann Oncol. 2005 Jul;16(7):1192-8. doi: 10.1093/annonc/mdi218. Epub 2005 Apr 28.
This randomized, open-label study evaluated the efficacy, safety and pharmacokinetics of darbepoetin alfa administered intravenously (i.v.) or subcutaneously (s.c.) in chemotherapy-induced anemia.
Patients received darbepoetin alfa i.v. (n=59) or s.c. (n=59) at a dose of 4.5 mug/kg once weekly for 6 weeks (correction phase) followed by 4.5 mug/kg once every 3 weeks for the remainder of the 18-week treatment period (maintenance phase).
During the correction phase, the mean [95% confidence interval (CI)] change in hemoglobin (intention-to-treat) was 1.1 (0.6-1.5) g/dl in the i.v. group and 1.3 (0.9-1.7) g/dl in the s.c. group; using available data, the mean change was 1.4 (1-1.9) g/dl and 1.6 (1.2-2) g/dl, respectively. The percentage (95% CI) of patients maintaining hemoglobin (i.e. average decrease < or =0.5 g/dl) during the maintenance phase was similar between the i.v. (82%; 95% CI 66% to 92%) and s.c. (80%; 95% CI 66% to 90%) groups. Thirty-five per cent (95% CI 20% to 50%) of patients in the i.v. group and 32% of patients in the s.c. group (95% CI 18% to 45%) received red blood cell transfusions during week 5 to the end of the treatment period. Darbepoetin alfa was well tolerated in both groups. No significant difference (P=0.36) in weekly darbepoetin alfa serum concentrations was observed between groups.
Darbepoetin alfa can be administered i.v. or s.c. at equal doses for the treatment of anemia in this setting.
这项随机、开放标签研究评估了静脉注射（i.v.）或皮下注射（s.c.）的阿法依泊汀在化疗所致贫血治疗中的疗效、安全性及药代动力学。
患者接受静脉注射阿法依泊汀（n = 59）或皮下注射阿法依泊汀（n = 59），剂量为4.5μg/kg，每周一次，共6周（纠正期），随后在18周治疗期的剩余时间里每3周注射4.5μg/kg（维持期）。
在纠正期，静脉注射组血红蛋白（意向性分析）的平均[95%置信区间（CI）]变化为1.1（0.6 - 1.5）g/dl，皮下注射组为1.3（0.9 - 1.7）g/dl；采用有效数据时，平均变化分别为1.4（1 - 1.9）g/dl和1.6（1.2 - 2）g/dl。在维持期，维持血红蛋白水平（即平均下降≤0.5 g/dl）的患者百分比（95% CI）在静脉注射组（82%；95% CI 66%至92%）和皮下注射组（80%；95% CI 66%至90%）中相似。静脉注射组35%（95% CI 20%至50%）的患者和皮下注射组32%（95% CI 18%至45%）的患者在第5周直至治疗期结束接受了红细胞输血。两组对阿法依泊汀的耐受性均良好。两组间阿法依泊汀血清浓度每周均无显著差异（P = 0.36）。
在此情况下，阿法依泊汀可采用相同剂量静脉注射或皮下注射来治疗贫血。
