Shalansky K, Jastrzebski J
Pharmaceutical Sciences CSU, Vancouver General Hospital, Faculty of Pharmaceutical Sciences, BC, Canada.
Clin Nephrol. 2005 Jul;64(1):55-63. doi: 10.5414/cnp64055.
In March 2003, our hemodialysis unit switched all patients from subcutaneous (s.c.) rHuEPO to intravenous (i.v.) darbepoetin. The primary outcome was to assess the efficacy of i.v. darbepoetin to maintain target serum hemoglobin (Hb) compared to s.c. rHuEPO. Secondary outcomes were to evaluate the manufacturer's recommend guidelines for conversion of rHuEPO to darbepoetin, and to assess the cost implications of darbepoetin therapy.
This was an 18-month open-label observational study of 95 hemodialysis patients. At the time of the switch to darbepoetin (baseline), data were collected retrospectively for six months and prospectively for 12 months, at three-month intervals. The first six months of darbepoetin therapy was considered a dose titration phase, thus, data were analyzed comparing two six-month periods: (-) six months to baseline (rHuEPO phase) and (+) 6-12 months (darbepoetin phase). Doses were titrated to a target Hb of 120-135 g/l.
There was no significant difference in Hb between phases at any time point. Mean Hb ranged from 119.6-121.5 g/l for rHuEPO and 121.9-123.4 g/l for darbepoetin. The median darbepoetin dose remained stable throughout the analysis at 30 microg/week while the median dose of rHuEPO rose from 8,000 U/week at minus six months to 9,000 U/week at baseline. Median 12-month cost savings associated with the administration of darbepoetin were estimated at 212,000 dollars. The recommended darbepoetin dose from the manufacturer's conversion table was deemed too low for baseline rHuEPO doses above 17,000 U/week. A more simplified dose conversion nomogram was created.
Darbepoetin was able to maintain similar serum Hb levels compared to rHuEPO at a substantially reduced cost.
2003年3月,我们的血液透析科室将所有患者从皮下注射重组人促红细胞生成素(rHuEPO)转换为静脉注射达贝泊汀。主要结果是评估与皮下注射rHuEPO相比,静脉注射达贝泊汀维持目标血清血红蛋白(Hb)水平的疗效。次要结果是评估制造商推荐的将rHuEPO转换为达贝泊汀的指南,并评估达贝泊汀治疗的成本影响。
这是一项针对95名血液透析患者的为期18个月的开放标签观察性研究。在转换为达贝泊汀时(基线),回顾性收集六个月的数据,并前瞻性收集12个月的数据,间隔三个月。达贝泊汀治疗的前六个月被视为剂量滴定阶段,因此,分析数据时比较了两个六个月的时间段:(-)六个月至基线(rHuEPO阶段)和(+)6 - 12个月(达贝泊汀阶段)。剂量滴定至目标Hb为120 - 135 g/l。
在任何时间点,各阶段之间的Hb均无显著差异。rHuEPO阶段的平均Hb范围为119.6 - 121.5 g/l,达贝泊汀阶段为121.9 - 123.4 g/l。在整个分析过程中,达贝泊汀的中位剂量保持稳定,为每周30微克,而rHuEPO的中位剂量从负六个月时的每周8000单位升至基线时的每周9000单位。估计与使用达贝泊汀相关的12个月成本节省中位数为212,000美元。对于基线rHuEPO剂量高于每周17,000单位的情况,制造商转换表中推荐的达贝泊汀剂量被认为过低。创建了一个更简化的剂量转换列线图。
与rHuEPO相比,达贝泊汀能够维持相似的血清Hb水平,但成本大幅降低。