Mydlík Miroslav, Derzsiová Katarína, Boldizsár Ján, Hríbiková Mária, Petrovicová Jozefína
Internal Medicine and Nephrology, Nephrological Clinic, University Hospital of L.Pasteur, Kosice, Slovak Republic.
J Ren Nutr. 2003 Jan;13(1):47-51. doi: 10.1053/jren.2003.50007.
To investigate if oral use of Sorbifer Durules (EGIS Pharmaceutical Ltd, Budapest, Hungary) (1 tablet/d) is adequate for the maintenance of serum iron and vitamin C in normal range during recombinant human erythropoietin treatment in hemodialyzed patients. One tablet of Sorbifer Durules contains 100 mg of Fe(2+) and 60 mg of vitamin C.
Short-term, open-label clinical trial.
Hemodialysis units.
Twenty-four adult patients with end-stage renal disease on hemodialysis.
Four-week treatment period of Sorbifer Durules, preceded and followed by iron and vitamin C washout periods.
Fasting predialysis serum samples were collected on days 0, 28, 56, and 84 to determine hematocrit, blood hemoglobin, serum iron, total iron-binding capacity, transferrin saturation, ferritin, vitamin C, and plasma oxalate.
Four-week treatment in hemodialyzed patients by Sorbifer Durules led to significant increase of hematocrit, blood hemoglobin, serum iron and vitamin C. This treatment did not influence the level of plasma oxalate.
Oral dose of one tablet of Sorbifer Durules per day is adequate for the maintenance of serum iron in normal range during recombinant human erythropoietin treatment in hemodialyzed patients. This treatment simultaneously prevented the development of serum vitamin C deficiency and did not lead to further increase of plasma oxalate in these patients.
研究口服索比菲缓释片（匈牙利布达佩斯EGIS制药有限公司生产）（每日1片）对于维持血液透析患者在接受重组人促红细胞生成素治疗期间血清铁和维生素C处于正常范围是否足够。1片索比菲缓释片含有100毫克二价铁和60毫克维生素C。
短期、开放标签临床试验。
血液透析单位。
24例接受血液透析的终末期肾病成年患者。
索比菲缓释片为期四周的治疗期，前后分别有铁和维生素C洗脱期。
在第0、28、56和84天采集透析前空腹血清样本，以测定血细胞比容、血红蛋白、血清铁、总铁结合力、转铁蛋白饱和度、铁蛋白、维生素C和血浆草酸盐。
血液透析患者接受索比菲缓释片四周治疗后，血细胞比容、血红蛋白、血清铁和维生素C显著增加。该治疗对血浆草酸盐水平无影响。
对于血液透析患者在接受重组人促红细胞生成素治疗期间，每日口服1片索比菲缓释片足以维持血清铁在正常范围。该治疗同时预防了血清维生素C缺乏的发生，且未导致这些患者血浆草酸盐进一步升高。
