蔗糖铁注射液治疗维持性血液透析患者肾性贫血的前瞻性、随机对照多中心研究

Intravenous iron sucrose in maintenance hemodialysis patients: a prospective randomized controlled multi-center clinical trial

目的比较蔗糖铁(森铁能)与右旋糖酐铁(科莫非)静脉注射液治疗维持性血液透析(MHD)患者缺铁性贫血的疗效与安全性。方法采用前瞻性、随机对照的多中心研究。 80例MHD患者分为试验组(蔗糖铁组)与对照组(右旋糖酐铁组),每组各40例。治疗前,两组患者男女性别比例、年龄、维持透析时间、血红蛋白(Hb)、红细胞比容(Hct)、铁蛋白(SP)和转铁蛋白饱和度(TSAT)等均无显著性差异。将100 mg蔗糖铁和100 mg右旋糖酐铁分别稀释于 100 ml生理盐水,于每次血透时使用。每周治疗2次,治疗时间为5周,观察时间共8周。两组患者的总补铁量均为1000 mg。全部病例都合并使用红细胞生成素(FPO)治疗,剂量为120～150 U·kg-1·周-1,皮下或静脉应用。观察并比较两组患者治疗贫血的效果、铁代谢指标变化及不良反应发生情况。结果经治疗后,试验组与对照组的Hb均较治疗前显著升高,分别为[(98．85± 17．45)g／L比 (75．20±9．66)g／L,P<0．01]和[(94．93±14．03)g／L比(75．53±10．61)g／L,P< 0．01];Hct也较治疗前明显升高(P<0．01),而试验组的上升幅度大于对照组,但差异无统计学意义。治疗后两组铁蛋白和转铁蛋白饱和度均明显高于治疗前,试验组铁蛋白为[(399．92± 200．90)μg／L比(106．61±78．24)μg／L,P<0．01];转铁蛋白饱和度为[(27．28±11．87)μg／L比 (17．95±9．17)μg/L,P<0．01]。试验组的上升幅度大于对照组,但两组相比差异无统计学意义。两组患者血清BUN、Scr、ALT和AST等均无明显变化。两组患者均无严重不良反应发生,对照组有1例发生下肢肌肉酸痛。结论蔗糖铁是治疗伴有缺铁的血液透析患者肾性贫血的一种安全而有效的药物。

Objective To investigate and compare the efficacy and safety of intravenous iron sucrose and iron dextran for the treatment of iron deficiency in anemic hemedialysis patients. Methods In this prospective randomized controlled multi-center clinical study, 80 chronic hemodialysis patients were divided into two groups： treatment group （iron sucrose group, n=40） and control group （iron dextran group, n=40）. There were no significant differences in the basic data （gender, age, duration of hemodialysis , Hb,Hct, ferritin and transferring saturation,etc）between two groups at pre-treatment. The patients were treated with iron sucrose or iron dextran, 100 mg intravenous, during 10 consecutive hemodialysis sessions, twice a week for five weeks. The durationof follow-up was eight weeks. The total supplement iron amount of both groups was 1000 mg. Erythropoietin （EPO） was used at a dose of 120-150 U-kg^-1·week^-1. The efficacy and safety were assessed by evaluating the changes in Hb, Hct, ferritin, transferring saturation and side effects in both groups pre- and post-treatment. Results Compared with the pre-treatment, the Hb levels in both groups significantly increased at post-treatment [iron sucrose group： （98.85±17.45）g/L vs （75.20±9.66） g/L,P 〈 0.01, iron dextran group： （94.93±14.03） g/L vs （75.53±10.61） g/L,P 〈 0.01, respectively]. The Hct levels in both groups significantly increased （P〈 0.01）. The levels of ferritin and transferring saturation increased significantly in both groups. The increament rates of Hb, Hct, ferritin and transferring saturation in iron sucrose group were higher than those in iron dextran group, although no significant difference occurred. There were no obvious changes in BUN, Scr, ALT and AST. There were no severe adverse events in both groups and 1 case suffered from muscular soreness in the lower limbs in iron dextran group. Conclusion Intravenous iron sucrose is an effective and safe agent for the treatment of iron deficiency in anemic hemodialysis patients.