多糖铁复合物对肾性贫血肾功能衰竭血液透析患者的补铁疗效与安全性观察

The efficacy and safety of polysacharide iron complex on hemodialysis patients for chronic renal failure with erythropoietin therapy

目的 了解慢性肾功能衰竭 (CRF)透析患者中缺铁的发生率 ,比较多糖铁复合物 (PIC)与琥珀酸亚铁两种铁剂对纠正CRF透析合并缺铁的疗效及安全性。方法 选择用促红细胞生成素(EPO)治疗的肾性贫血的慢性肾衰透析患者 2 0 3例 ,随机分为治疗组与对照组 ,分别给予PIC 30 0mg/d或 6 0 0mg/d与琥珀酸亚铁 30 0mg/d或 6 0 0mg/d ,以 3个月为一疗程。所有入选病例均皮下注射α或 β促红素 ,每次 2 0 0 0～ 30 0 0U ,每周 2～ 3次。每 4周复查血常规、血清铁蛋白 (SF)和转铁蛋白饱和度 (TS) ,另于治疗前后各检查肝、肾功能 1次 ,观察治疗期间可能产生的不良反应 ,并进行严重程度的评估。结果 口服常规剂量的PIC 30 0mg/d或 6 0 0mg/d ,在 8～ 12周内能有效纠正慢性肾衰、肾性贫血患者的缺铁状态 ,总有效率达 94 1% ,优于琥珀酸亚铁常规剂量组 (87 5 % ,P <0 0 1) ,并且其副作用发生率远远低于琥珀酸亚铁。结论 CRF患者中缺铁发生率高 ,口服PIC对纠正缺铁是一种安全、有效 。

Objective To find the occurrence rate of iron deficiency in patients of chronic renal failure(CRF) with hemodialysis treatment. To compare the efficacy and safety of polysacharide iron complex (PIC) capsule and ferrous succinate tablet in these patients with erythropoietin (EPO) therapy. Method In a three month, open label trial, 203 CRF patients with hemodialysis treatment were given PIC 300 or 600 mg/day and ferrous succinate tablet 300 or 600 mg/day. All the patients received α or β EPO 2 000～3 000 U, two to three times a week. Hematologic assay was performed at the end of every month. The adverse reactions were monitored. Results The efficacy of PIC 300 or 600 mg/day is better than ferrous succinate 300 or 600 mg/day (94.1% vs 87.5%) in CRF patients and the tolerance to PIC is much better than that to ferrous succinate. Conclusion This study demonstrated that the occurrence rate of iron deficiency among patients of chronic renal failure(CRF)is quite high and administration of PIC orally is effective and safe for iron deficiency in CRF patients with hemodialysis treatment.