静脉用右旋糖酐氢氧化铁注射液治疗血液透析患者肾性贫血的随机及多中心对照临床研究

目的 评价右旋糖酐氢氧化铁注射液治疗维持性血液透析(血透)患者铁缺乏的有效性与安全性。方法 159例维持性血透患者,肾性贫血程度:血红蛋白(Hb)60～90 g/L,或红细胞压积(Hct)0.18～0.27,随机分为静脉组与口服组,分别采用静脉注射右旋糖酐氢氧化铁及口服琥珀酸亚铁进行补铁治疗,总疗程8周。检测治疗前后血清铁指标、红细胞相关指标及生化指标,并对不良反应进行监测。结果 (1)共136例完成本研究,其中静脉组70例、口服组66例,两组患者年龄、性别、贫血程度、血清铁指标及EPO用量相匹配。(2)治疗8周时,静脉组Hb及Hct显著升高,分别上升(25.5±18.7)％和(28.9±21.1)％,幅度明显高于口服组[(12.0±16.8)％和(16.7±22.5)％],P<0.001。(3)治疗8周后两组血清铁蛋白(SF)与转铁蛋白饱和度(TSAT)均较治疗前显著升高,且静脉组升高幅度[SF(316.0±398.0)％,TSAT(89.7±99.0)％】明显高于口服组[SF(157.0±454.0)％,TSAT(35.2±57.0)％】,P<0.001。(4)治疗8周后静脉组血清白蛋白及血清钾较治疗前升高,白蛋白由(36.9±5.2)g/L升至(39.3±5.9)g/L,血清钾由(4.8±0.8)mmol/L升至(5.1±0.9)mmol/L,P<0.01。两组治疗前后血WBC及其它生化指标均相近。(5)静脉组4例有不良反应,1例出现药物相关皮疹,停药后消失,1例轻微心悸,2

Intravenous iron dextran treatment in chronic hemodialysis

Objective To investigate the safety and efficiency of intravenous iron-dextran in chronic hemodialysis patients. Methods One hundred and thirty-six patients on chronic hemodialysis were involved in this eight-week, randomized, controlled, multicenter trial. Seventy patients received intravenous iron dextran (IID) and 66 received ferrous succinate (FS). Levels of serum ferritin (SF), transferrin saturation (TSAT), hemoglobin (Hb) and hematocrit (Hct) were tested before and after the treatment. Results After treatment, the levels of Hb, Hct, SF and TSAT were all significantly increased in IID, which were also significantly higher than those in FS. The levels of serum albumin and potassium elevated significantly in IID, but no obvious changes of above both indexes were found in FS. One case in IID presented rash during the treatment and recovered soon after drug withdrawal. Seventeen cases in FS showed adverse gastrointestinal effects. The rate of side-effect in IID(5. 7% ) was significantly lower than that in FS (25.8% , P < 0.005) . Conclusion Intravenous iron dextran can effectively increase serum iron parameters and hemoglobin levels in chronic hemodialysis patients, with relatively high degree of safety.