摘要
目的比较静脉用铁剂蔗糖铁(维乐福)、口服铁剂琥珀酸亚铁(速力菲)分别与基因重组人红细胞生成素(EPO)联合应用,治疗伴有缺铁的维持性血液透析患者肾性贫血的有效性和安全性。方法采用前瞻性、随机、对照的多中心研究。120例血透患者分为静脉组和口服组,每组各60例。静脉组:200mg蔗糖铁稀释于100ml生理盐水,每次透析时使用,直至完成总预计补铁量。总预计补铁量=体重(kg)×(150-Hb实际值)(g/L)×0.24+500(mg)。口服组:琥珀酸亚铁200mg每日3次,共8周。两组患者均使用EPO治疗,剂量为120～150U·kg-1·周-1,皮下或静脉应用。观察并比较两组患者贫血治疗的效果、铁代谢指标的变化及不良反应发生情况。结果治疗前静脉组与口服组间在男女性别比例、年龄、体重和接受治疗前维持透析时间及血红蛋白(Hb)、铁蛋白和转铁蛋白饱和度等方面均无显著差异。治疗后静脉组Hb犤(90.9±15.8)比(74.6±8.3)g/L,P<0.001犦和口服组Hb犤(84.5±11.9)比(76.6±7.8)g/L,P<0.001犦均较治疗前明显升高。而静脉组Hb上升幅度明显高于口服组犤(17.9±10.1)比(7.9±11.0)g/L,P<0.001犦;其治疗时间明显短于口服组犤(5.2±0.4)比8.0周,P<0.001犦;静脉组Hb上升速度明显快于口服组犤(3.5±2.0)比(1.0±1.4)g·L-1·周-1,P=0.003犦。
Objective To determine and compare the efficacy and safety of intravenous iron sucrose with oral ferrous succinate in rHuEPO treated hemodialysis patients. Methods One hundred and twenty chronic hemodialysis patients were divided into two groups: (1) Intravenous iron group (IV group). 200 mg iron sucrose was intravenously pumped during each hemodialysis session. The total intravenous iron amount needed for each patient was calculated by the following formula:iron amount=body weight(kg)×[150-measured hemoglobin(Hb) value (g/L)]×0 24+500(mg). (2) Oral iron group (Oral group). 200 mg ferrous succinate three times a day for eight weeks. Each patient of both groups received recombinent human erythropoetin (rHuEPO) treatment,120～150 U·kg-1·week-1. The efficacy was assessed by determining the subsequent change in Hb, ferritin, and transferrin saturation values. Results There were no differences between intravenous and oral groups in sex, age, body weight, duration of hemodialysis, Hb values, ferritin and transferrin saturation before treatment. At the end of the trial, the Hb levels in both groups significantly increased[Ⅳgroup,(90 9±15 8) vs (74.6±8.3)g/L,P< 0.001; and Oral group, (84.5±11.9) vs (76.6±7.8)g/L, P< 0.001,respectively], but the Hb increment rate in Ⅳgroup was markedly faster than that in oral group[Ⅳgroup(3.5±2.0) vs Oral group(1.0±1.4)g·L-1·week-1, P=0 003]. There was no significant difference in average dosages of rHuEPO between two groups [Ⅳgroup(120±25) vs Oral group(119±37)U·kg-1·week-1, P=0.081]. The levels of ferritin and transferrin saturation significantly increased in both groups, but the levels of ferritin and transferrin saturation in Ⅳgroup were higher than that in oral group respectively [ferritin (627±354) in Ⅳgroup vs (191±274)μg/L in oral group, P< 0 001; transferrin saturation, 0.38±0.15 in IV group vs 0.27±0.10 in oral group, P=0.001]. The serum levels of Scr, BUN, AST, ALP, Alb and CRP in both groups did not change significantly. There were no s
出处
《中华肾脏病杂志》
CAS
CSCD
北大核心
2004年第1期51-55,共5页
Chinese Journal of Nephrology
