目的:比较蔗糖铁(静脉注射)与富马酸亚铁(口服)治疗老年维持性血液透析(MHD)患者肾性贫血的有效性及安全性。方法采用随机、对照的多中心研究,将80例老年血液透析患者随机分为蔗糖铁组(n=40,0.9%氯化钠溶液100ml+蔗糖铁100mg,静脉滴注,2次/周,透析结束前30min执行)及富马酸亚铁组(n=40,每天口服富马酸亚铁颗粒200mg,3次/d,餐前1h或餐后2h服用),两组均采用促红细胞生成素(EPO)治疗,剂量为120∽150U/(kg·周)皮下或静脉应用。观察比较两组患者血红蛋白(Hb)及铁代谢指标的变化及不良反应发生情况。结果治疗4周后,与富马酸亚铁组比较,蔗糖铁组Hb、血细胞比容(Hct)、血清铁蛋白(SF)及血清铁蛋白饱和度(TS)升高更明显(P〈0.05);治疗12周后,两组的Hb、HCT、SF及TS均增高(P〈0.01),与富马酸亚铁组比较,蔗糖铁组增加更显著(P〈0.05)。蔗糖铁组的总有效率高于富马酸亚铁组(92.5%vs75.0%),不良反应发生率低于富马酸亚铁组(2.5%vs14.2%),差异有统计学意义(P〈0.05)。结论与富马酸亚铁口服铁剂比较,蔗糖铁(静脉注射)有效地增加了老年MHD肾性贫血患者Hb浓度、铁的利用和贮存,可作为此类患者长期补铁的方法之一。
Objective To compare the efficacy and safety of iron sucrose (intravenous injection) and ferrous fumarate granules (oral medication) in the treatment of renal anemia on elderly patients undergoing maintenance hemodialysis. Methods In this randomized controlled multi-center clinical study,80 elderly maintenance hemodialysis patients were divided into two groups:iron sucrose group (n=40,receiving iron sucrose 100 mg twice a week.);ferrous fumarate group (n=40,receiving ferrous fumarate 200 mg three times per day).Patients of both groups received recombinant human ery-thropoietin (EPO) treatment,120-150 U/(kg·week).The efficacy was assessed by determining the subsequent change in hemoglobin (Hb),ferritin and transferrin saturation values etc. Results Compared with the ferrous fumarate group,the levels of Hb,hematocrit (Hct),serum ferritin (SF),transferrin saturation (TS) of the iron sucrose group were higher than those of the ferrous fumarate group at 4 weeks after treatment (P〈0.05);Compared with baseline levels,the levels of Hb, Hct,SF and TS of all patients increased at 12 weeks after treatment (P〈0.01);the Hb,Hct,SF and TS levels of iron su-crose group were higher than those of the ferrous fumarate group (P〈0.05).The effective rate of the iron sucrose group was higher than that of the ferrous fumarate group (92.5% vs 75.0%,P〈0.05),and there were less adverse effects in the iron sucrose group than that in the iron sucrose group (2.5% vs 14.2%,P〈0.05). Conclusion Compared with the fer rous fumarate (oral medication),iron sucrose (intra-venous injection) can effectively increase hemoglobin concentration and raise the usage and the storage of the old-aged maintenance hemodialysis patients.Iron su-crose can be uesd as long-term iron supplementation for them.