蔗糖铁注射液治疗维持性血液透析患者肾性贫血的临床疗效

Clinical Effect of Intravenous Iron Sucrese Injection for the Treatment of Renal Anemia in Maintenance Hemodialysis Patients

【目的】比较蔗糖铁与右旋糖酐铁注射液静脉注射治疗维持性血液透析（MHD）患者缺铁性贫血的疗效与安全性。【方法】100例MHD患者随机分为试验组（蔗糖铁组）与对照组（右旋糖酐铁组），每组各50例。将100mg蔗糖铁和100mg右旋糖酐铁分别稀释100mL生理盐水，于每次血液透析时使用。每周治疗1次，治疗时间为10周，观察12周。两组患者的总铁量1000mg，所有病例都合并使用促红细胞生成素（EP0）治疗，剂量为每周120～150u／kg，皮下或者静脉应用。观察并比较两组患者治疗贫血的效果，铁代谢指标的变化及不良反应发生的情况。【结果】两组的血红蛋白（Hb）均较治疗前显著升高（均P〈0．01）；红细胞比容（HCT）也较治疗前显明升高（均P〈0．01），而试验组的上升幅度大于对照组，但两组相比较差异无统计学意义（均P〈0．01）。两组血清尿素氮、肌酐、转氨酶等均无明显变化。两组患者均无严重的不良反应发生。【结论】蔗糖铁是治疗伴有缺铁性贫血血液透析患者的一种安全有效的药物。

[Objective]To investigate the efficacy and safety of intravenous iron sucrese injection and iron dextran for the treatment of iron deficiency in renal anemia in maintenance hemodialysis （MHD） patients. [Methods]In this prospective randomized controlled multi-center clinical study, 100 MHD patients were divid ed into treatment group （iron sucrese injection group, n = 50） and control group （iron dextran group, n = 50）. The patients were treated with intravenous iron sucrese injection or iron dextran 100mg during 10 consecutive hemodialysis sessions, once a week for 10 weeks. The follow-up was 12 weeks. The total supplement iron amount of both groups was 100mg. Erythropoietin（EPO） was used at a dose of 120-150 u/（kg · week）. The efficacy and safety were assessed by evaluating the change of Hb; ferritin and the side effects in both groups before and after treatment. [Results] Compared with the pre-treatment, Hb and HCT in both groups increased significantly（ P 〈0.01）, and those in treatment group were higher than those in control group, but there was no significant difference（ P 〈0.01） between two groups. BUN, SCR and AST in serum in both groups had no obvious change. No severe complication happened in both group. [Conclusion] Intravenous iron sucrese injection is effective and safe for the treatment of iron deficiency in hemodialysis patients.