蔗糖铁注射液治疗血液透析患者肾性贫血的多中心临床研究

Intravenous iron sucrose therapy in anemic hemodialysis patients:a prospective randomized controlled multicentric clinical trial

目的比较蔗糖铁与口服琥珀酸亚铁治疗血液透析患者肾性贫血的疗效与安全性。方法采用同期随机对照的多中心研究。结果选择维持性血液透析患者中肾性贫血者77例,静脉给药组40例,口服铁剂组37例,除口服组血红蛋白(Hb)均值(90.34g/L)高于静脉组(84.31g/L,P﹤0.05)外,两组年龄、性别、身高、干体重等基础情况均无显著性差异。治疗后Hb、红细胞压积(HCT)、网织红细胞计数(Ret)两组均有升高,静脉组Hb、HCT比口服组升高更显著(P﹤0.001),且Hb上升速度快于口服组;该组血清铁、铁蛋白、转铁蛋白饱和度治疗后均升高(P﹤0.001),且升高幅度大于口服组(P﹤0.001);静脉组不良反应少于口服组(P﹤0.05)。结论静脉用蔗糖铁治疗肾性贫血安全有效。

objective To determine and compare the efficacy and safety of intravenous iron sucrose （abbreviated as： iv group） with that of oral ferrous succinate （ abbreviated as：oral group） in rhuEPO - treated hemodialysis patients. Methods This is a concommitent randomized controlled multicentric clinical study. Results Seventy- seven patients were divided into 2 groups：40 in iv group and 37 in oral group. The baseline characteristics were comparable except that the hemoglobulin （Hb） in the oral group was higher than that in iv group. At the end of the trial, the Hb, hemotocrit （HCT） and reticular erythrocytes （Ret） were significantly increased in both groups while the increment of Hb and HCT in iv group was significantly higher than that in oral group （P 〈 0.001）. The increment rate of Hb in iv group was markly faster than that in oral group. Serum iron, ferritin and transferrin saturation increased significantly in iv group （P 〈 0.001） while the increment of serum iron indice in iv group was significantly higher than that in the oral group （P 〈 0.001）. There was less adverse effects in iv group than in oral group （P 〈 0.05）. Conclusions Intravenous iron sucrose is effective and safe in treating anemic hemodialysis patients.