右旋糖酐氢氧化铁治疗肾性贫血的临床研究

目的比较静脉注射右旋糖酐氢氧化铁(科莫非)与口服多糖铁复合物(力蜚能)治疗维持性血液透析患者肾性贫血的疗效与安全性。方法 40例病情稳定的血液透析患者,规律透析2～3次/周。所有患者血红蛋白(Hb)60～100 g/L或红细胞压积(Hct)<30%,血清铁蛋白(SF)<200μg/L,转铁蛋白饱和度(TSAT)<30%,接受皮下注射重组人促红细胞生成素(rHuEPO)每周100～150 U/kg。将上述患者随机分为口服治疗组和静脉治疗组,每组20例,观察期为24周。口服组予多糖铁复合物150 mg/d。静脉组每次透析时静脉滴注右旋糖酐氢氧化铁100 mg,累计1 000 mg后每2周给予维持量100 mg。若患者的Hb达到110 g/L或Hct达到33%以上,则将rHuEPO减量以维持Hb及Hct水平。检测补铁前及补铁4、8、12、24周时患者Hb、Hct、SF以及TSAT水平。结果治疗后两组Hb、Hct、SF、TSAT均较治疗前有明显升高(P<0.05),静脉组Hb、Hct、SF、TSAT上升幅度均高于口服组(P<0.05)。治疗后24周静脉组rHuEPO用量较治疗前及口服组明显减少(P<0.05)。两组治疗前后肝功能差异无统计学意义。治疗后静脉组血清C反应蛋白高于治疗前及口服组,但仍在正常范围内。静脉组不良反应1例,口服组不良反应4例。结论静脉用右旋糖酐氢氧化铁治疗肾性贫血安全有效,不良反应少,且可减少rHuEPO用量。

Effect of iron dextran injection on renal anemia

Objective To determine the effect of iron dextran injection on renal anemia and its influence on erythropoietin(EPO)dose in maintenance hemodialysis patients. Methods 40 maintenance hemodialysis patients were enrolled in the clinical trial,whose hemoglobin(Hb)ranged between 60～100 g/L or hematocrit(Hct)was less than 30%.At the same time,serum ferritin(SF)was less than 200 μg/L and transferring saturation(TSAT)was less than 30%.All patients received recombinant human erythropoietin(rHuEPO)at the dose of 100～150 U/kg each week.The patients were randomly divided into two groups and observed for six months.Oral group(n=20)received polysaccharide-iron complex(PIC)at the dose of 150 mg/d;and intravenous iron group received iron dextran injection(IDI)at the dose of 100 mg during every hemodialysis for 10 times,then they were intravenously treated with 100 mg IDI every two weeks.The dose of rHuEPO reduced when Hb raised to more than 110 g/L or Hct increased to more than 33%.Levels of SF,TSAT,Hb and Hct were examined during the experiment. Results Levels of SF,TSAT,Hb and Hct significanly increased in both PIC group and IDI group(P<0.05).However,the increase of these laboratory parameters was significantly higher and faster in IDI group than that of PIC group(P<0.05).After treatment of 24 weeks,the dose of rHuEPO in IDI group was significantly less than that before treatment and in PIC group(P<0.05).There were less adverse events in IDI group than PIC group(1 cases vs 6 cases).No difference was observed in liver function and serum CRP between the two groups before and after the experiment. Conclusion IDI is more effective and safer for treatment of renal anemia in maintenance hemodialysis patients than PIC,and can decrease the dose of rHuEPO.