静脉用右旋糖酐氢氧化铁注射液治疗腹膜透析患者肾性贫血的临床研究

目的评价右旋糖酐氢氧化铁注射液治疗腹膜透析患者铁缺乏的有效性及安全性。方法选择第二军医大学附属长海医院肾内科59例长期不卧床腹膜透析(CAPD)患者,肾性贫血程度:血红蛋白(Hb)60～90g/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。检测治疗前治疗后8周时血清铁指标、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50例完成本临床研究,其中静脉组与口服组各25例,两组患者年龄、性别、贫血程度、血清铁指标及促红细胞生成素(EPO)用量相匹配。②治疗8周时,静脉组Hb及Hct显著升高,分别为(24.1±17.9)%和(27.2±19.7)%,幅度明显高于口服组(12.1±16.5)%和(15.8±11.8)%],P<0.001。③治疗8周时,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(487.3±390.8)%,TSAT(93.1±87.0)%]明显高于口服组SF(178.9±271.7)%,TSAT(38.9±41.7)%],P<0.001。④治疗8周时,静脉组血清白蛋白及血清钾较治疗前升高,白蛋白由(35.7±6.1)g/L升至(39.4±5.9)g/L,血清钾由(4.1±0.7)g/L升至(4.9±0.8)g/L,P<0.01。两组治疗前后血白细胞及其它生化指标均相近。⑤静脉组2例有不良反应,其中1例轻微心悸,1例轻度胃肠道反应。口服组7例出现明显胃肠道症状。静脉组总不良反应发生率(2/25,8.0%)明显低于口服组(7/25,28.0%),P<0.01。结论①静脉注射右旋糖酐氢氧化铁可有效纠正CAPD患者的铁缺乏、提高铁利用率及EPO的治疗效果。②静脉注射右旋糖酐氢氧化铁临床应用不良反应发生率低、安全性良好。

Intravenous iron dextran treatment in patients with renal anemia on peritoneal dialysis

Objective To investigate the safety and efficiency of intravenous iron dextran in patients on peritoneal dialysis. Methods Fifty-nine patients on peritoneal dialysis were involved in this eight-week, randomized, controlled trial. Twenty-five patients received intravenous iron dextran(IID) and 25 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 the treatments, the levels of Hb, Hct, SF and TSAT were all significantly increased in IID group, which were also significantly higher than those in FS group. The levels of serum albumin and potassium elevated significantly in IID group, but no obvious changes of above both indexes found in FS group. Seven cases in FS showed adverse gastrointestinal effects. The rate of side-effect in IID(8.0%) was significantly lower than that in FS group(2.8%, P < 0.01). Conclusion Intravenous iron dextran can effectively increase serum iron parameters and hemoglobin levels in peritoneal dialysis patients, with relatively high safety.