Nissenson A R, Lindsay R M, Swan S, Seligman P, Strobos J
University of California at Los Angeles Medical Center, 90095, USA.
Am J Kidney Dis. 1999 Mar;33(3):471-82. doi: 10.1016/s0272-6386(99)70184-8.
A new intravenous (i.v.) iron compound, sodium ferric gluconate complex in sucrose (Ferrlecit, R&D Laboratories, Inc, Marina Del Rey, CA), was administered over 8 consecutive dialysis days in equally divided doses to a total of either 0.5 or 1.0 g in a controlled, open, multicenter, randomized clinical study of anemic, iron-deficient hemodialysis patients receiving recombinant human erythropoietin (rHuEPO). Effectiveness was assessed by increase in hemoglobin and hematocrit and changes of iron parameters. Results were compared with historically matched controls on oral iron. High-dose i.v. treatment with 1.0 g sodium ferric gluconate complex in sucrose resulted in significantly greater improvement in hemoglobin, hematocrit, iron saturation, and serum ferritin at all time points, as compared with low-dose i.v. (0.5 g) or oral iron treatment. Despite an initial improvement in mean serum ferritin and transferrin saturation, 500 mg i.v. therapy did not result in a significant improvement in hemoglobin at any time. Eighty-three of 88 patients completed treatment with sodium ferric gluconate complex in sucrose: 44 in the high-dose and 39 in the low-dose group. Two patients discontinued for personal reasons. The other three discontinued because of a rash, nausea and rash, and chest pain with pruritus, respectively. In comparison with 25 matched control patients, adverse events could not be linked to drug therapy, nor was there a dose effect. In conclusion, sodium ferric gluconate complex in sucrose is safe and effective in the management of iron-deficiency anemia in severely iron-deficient and anemic hemodialysis patients receiving rHuEPO. This study confirms the concepts regarding iron therapy expressed in the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) that hemodialysis patients with serum ferritin below 100 ng/mL or transferrin saturations below 18% need supplementation with parenteral iron in excess of 1.0 g to achieve optimal response in hemoglobin and hematocrit levels.
在一项针对接受重组人促红细胞生成素（rHuEPO）治疗的缺铁性贫血血液透析患者的对照、开放、多中心随机临床研究中，一种新的静脉注射铁化合物——蔗糖铁葡糖酸钠复合物（Ferrlecit，R&D Laboratories，Inc，加利福尼亚州玛丽娜德尔雷），在连续8个透析日以等份剂量给药，总量分别为0.5克或1.0克。通过血红蛋白和血细胞比容的增加以及铁参数的变化来评估有效性。将结果与历史上匹配的口服铁剂对照组进行比较。与低剂量静脉注射（0.5克）或口服铁剂治疗相比，高剂量静脉注射1.0克蔗糖铁葡糖酸钠复合物在所有时间点的血红蛋白、血细胞比容、铁饱和度和血清铁蛋白改善均显著更大。尽管平均血清铁蛋白和转铁蛋白饱和度最初有所改善，但500毫克静脉注射治疗在任何时候都未导致血红蛋白显著改善。88例患者中有83例完成了蔗糖铁葡糖酸钠复合物治疗：高剂量组44例，低剂量组39例。2例患者因个人原因停药。另外3例分别因皮疹、恶心伴皮疹以及胸痛伴瘙痒而停药。与25例匹配的对照患者相比，不良事件与药物治疗无关，也不存在剂量效应。总之，蔗糖铁葡糖酸钠复合物在治疗接受rHuEPO的严重缺铁性贫血血液透析患者的缺铁性贫血方面是安全有效的。本研究证实了美国国家肾脏基金会透析预后质量倡议（NKF-DOQI）中关于铁剂治疗的观点，即血清铁蛋白低于100纳克/毫升或转铁蛋白饱和度低于18%的血液透析患者需要补充超过1.0克的胃肠外铁剂，以实现血红蛋白和血细胞比容水平的最佳反应。
