De Schoenmakere G, Lameire N, Dhondt A, Van Loo A, Van der Goten J, Duym P, Vanholder R
Department of Internal Medicine, University Hospital, Gent, Belgium.
Nephrol Dial Transplant. 1998 Jul;13(7):1770-5. doi: 10.1093/ndt/13.7.1770.
Previous studies comparing intravenous (i.v.) and subcutaneous (s.c.) administration of recombinant human erythropoietin (rHuEpo) often did not achieve optimal iron reserve, were restricted to a limited follow-up period (not allowing equilibration) and/or did not exclude the role of other confounding factors. In addition all papers focused on the conversion from i.v. to s.c.
In this study, 30 equilibrated patients on s.c. rHuEpo were randomized into two groups, one converting to i.v. after 6 months of follow-up and one remaining on s.c. rHuEpo. In both groups rHuEpo was administered three times weekly. Only patients completing a further 6 months follow-up were considered for statistical evaluation. Serum ferritin was targeted at 200 ng/ml and haematocrits between 28 and 36% were pursued.
The average haematocrit levels before conversion were 31.9 +/- 1.1% in the conversion group and 31.4 +/- 1.6% at the same time point in the nonconversion group (P = NS). After 6 months haematocrits were 31.5 +/- 0.5% in the conversion group and 31.1 +/- 0.9% in the non-conversion group (P = NS). Ferritin concentration in the conversion group was 219 +/- 49 ng/ml before and 230 +/- 83 ng/ml after the conversion. For the non-conversion group ferritin was 224 +/- 25 ng/ml and 236 +/- 52 ng/ml respectively (P = NS). The weight-standardized average rHuEpo dose per injection remained the same in the conversion group before and after conversion (44.0 +/- 1.8 U/kg/injection vs 45.4 +/- 4.7 U/kg/injection) (P = NS). In the non-conversion group the corresponding rHuEpo doses were 32.9 +/- 4.2 U/kg/injection and 39.6 +/- 7.0 U/kg/injection respectively (P = NS). There were no differences in serum PTH, aluminium, vitamin B12, folic-acid levels, and intake of co-trimoxazole, ACE inhibitors or theophylline.
No changes in rHuEpo dose were observed after conversion from s.c. to i.v. There were no significant differences between the conversion and non-conversion group. These results are in contrast to some earlier studies suggesting lower rHuEpo requirements in case of s.c. administration.
以往比较重组人促红细胞生成素（rHuEpo）静脉注射（i.v.）和皮下注射（s.c.）的研究往往未达到最佳铁储备，随访期有限（不允许达到平衡状态）和/或未排除其他混杂因素的作用。此外，所有论文都集中在从静脉注射转换为皮下注射方面。
在本研究中，30例接受皮下注射rHuEpo且状态已平衡的患者被随机分为两组，一组在随访6个月后转换为静脉注射，另一组继续接受皮下注射rHuEpo。两组均每周皮下注射rHuEpo三次。仅将完成另外6个月随访的患者纳入统计评估。血清铁蛋白目标值为200 ng/ml，追求的血细胞比容在28%至36%之间。
转换组转换前的平均血细胞比容水平为31.9±1.1%，非转换组在同一时间点为31.4±1.6%（P=无显著性差异）。6个月后，转换组的血细胞比容为31.5±0.5%，非转换组为31.1±0.9%（P=无显著性差异）。转换组转换前铁蛋白浓度为219±49 ng/ml，转换后为230±83 ng/ml。非转换组铁蛋白分别为224±25 ng/ml和236±52 ng/ml（P=无显著性差异）。转换组转换前后每次注射的体重标准化平均rHuEpo剂量保持不变（44.0±1.8 U/kg/注射 vs 45.4±4.7 U/kg/注射）（P=无显著性差异）。非转换组相应的rHuEpo剂量分别为32.9±4.2 U/kg/注射和39.6±7.0 U/kg/注射（P=无显著性差异）。血清甲状旁腺激素、铝、维生素B12、叶酸水平以及复方新诺明、血管紧张素转换酶抑制剂或茶碱的摄入量均无差异。
从皮下注射转换为静脉注射后，未观察到rHuEpo剂量的变化。转换组和非转换组之间无显著差异。这些结果与一些早期研究相反，那些研究表明皮下注射时rHuEpo需求量较低。
