Schiesser Daniela, Binet Isabelle, Tsinalis Dimitrios, Dickenmann Michael, Keusch Gérald, Schmidli Markus, Ambühl Patrice M, Lüthi Liudmila, Wüthrich Rudolf P
Canonical Hospital of Walenstadt, Switzerland.
Nephrol Dial Transplant. 2006 Oct;21(10):2841-5. doi: 10.1093/ndt/gfl419. Epub 2006 Aug 5.
Haemodialysis patients need sustained treatment with intravenous iron because iron deficiency limits the efficacy of recombinant human epoetin therapy in these patients. However, the optimal intravenous iron maintenance dose has not been established yet.
We performed a prospective multicentre clinical trial in iron-replete haemodialysis patients to evaluate the efficacy of weekly low-dose (50 mg) intravenous iron sucrose administration for 6 months to maintain the iron status, and to examine the effect on epoetin dosage needed to maintain stable haemoglobin values in these patients. Fifty patients were enrolled in this prospective, open-label, single arm, phase IV study.
Forty-two patients (84%) completed the study. After 6 months of intravenous iron sucrose treatment, the mean ferritin value showed a tendency to increase slightly from 405 +/- 159 at baseline to 490 +/- 275 microg/l at the end of the study, but iron, transferrin levels and transferrin saturation did not change. The haemoglobin level remained stable (12 +/- 1.1 at baseline and 12.1 +/- 1.5 g/dl at the end of the study). The mean dose of darbepoetin alfa could be reduced from 0.75 to 0.46 microg/kg/week; epoetin alfa was decreased from 101 to 74 IU/kg/week; and the mean dose of epoetin beta could be reduced from 148 to 131 IU/kg/week at the end of treatment.
A regular 50 mg weekly dosing schedule of iron sucrose maintains stable iron stores and haemoglobin levels in haemodialysed patients and allows considerable dose reductions for epoetins. Low-dose intravenous iron therapy may represent an optimal approach to treat the continuous loss of iron in dialysis patients.
血液透析患者需要持续进行静脉补铁治疗，因为缺铁会限制重组人促红细胞生成素疗法对这些患者的疗效。然而，最佳的静脉补铁维持剂量尚未确定。
我们对铁储备充足的血液透析患者进行了一项前瞻性多中心临床试验，以评估每周低剂量（50毫克）静脉注射蔗糖铁6个月维持铁状态的疗效，并研究其对维持这些患者稳定血红蛋白值所需促红细胞生成素剂量的影响。50名患者参与了这项前瞻性、开放标签、单臂IV期研究。
42名患者（84%）完成了研究。静脉注射蔗糖铁治疗6个月后，平均铁蛋白值呈轻微上升趋势，从基线时的405±159微克/升升至研究结束时的490±275微克/升，但铁、转铁蛋白水平及转铁蛋白饱和度未发生变化。血红蛋白水平保持稳定（基线时为12±1.1克/分升，研究结束时为12.1±1.5克/分升）。治疗结束时，阿法达贝泊汀的平均剂量可从0.75微克/千克/周降至0.46微克/千克/周；阿法依泊汀从101国际单位/千克/周降至74国际单位/千克/周；贝他依泊汀的平均剂量可从148国际单位/千克/周降至131国际单位/千克/周。
每周定期注射50毫克蔗糖铁的给药方案可维持血液透析患者稳定的铁储备和血红蛋白水平，并可大幅降低促红细胞生成素的剂量。低剂量静脉补铁疗法可能是治疗透析患者持续性铁流失的最佳方法。
