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Zhonghua yi xue za zhi · Feb 2009
Randomized Controlled Trial[Intravenous iron sucrose in maintenance dialysis patients with renal anemia: a clinical study].
- Han Li and Shi-Xiang Wang.
- Blood Purification Center, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China.
- Zhonghua Yi Xue Za Zhi. 2009 Feb 24; 89 (7): 457-62.
ObjectiveTo explore the safety and efficacy of intravenous iron sucrose in maintenance dialysis and to establish the optimal administration frequency and dose.MethodsOne hundred and ninety-four patients on maintenance dialysis with the hemoglobin (Hb) level of 60 - 100 g/L and hematocrit (Hct) of 18% - 30% were randomly divided into 2 sex, age, duration of dialysis, weekly erythropoietin dosage, and hematological parameters-matched groups: intravenous iron sucrose group (n = 102) and oral medication group (n = 92). The intravenous iron sucrose group were sub-divided into 2 subgroups: (1) hemodialysis (HD) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 100 mg once a week for a further 8 weeks, and (2) peritoneal dialysis (PD) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 200 mg once every other week for a further 8 weeks. The oral medication group received ferrous succinate 200 mg tid for 12 weeks. The levels of serum ferritin (SF), transferrin saturation (TSAT), Hb, and Hct were examined before treatment and 4, 8, and 12 weeks after treatment.Results(1) Compared with baseline levels, the levels of Hb, Hct, SF, and TSAT significantly increased 2 weeks after treatment in the intravenous iron sucrose group, and 4 weeks after treatment in the oral medication group (all P < 0.05). (2) The Hb, Hct, SF, and TSAT levels 4, 6, 8, and 12 weeks after treatment of the 2 intravenous iron sucrose subgroups were all significantly higher than those of the oral medication group (all P < 0.05). (3) The Hb, Hct, SF, and TSAT levels 12 weeks after treatment 6, 8, and 12 weeks after treatment were not significantly different from those 4 weeks after treatment in the intravenous iron sucrose group (all P > 0.05). (4) The response rate of the intravenous iron sucrose group was 95.09%, significantly higher than that of the oral medication group (55.44%, P < 0.05). (5) The mean EPO doses 6, 8 and 12 weeks after treatment of the intravenous iron sucrose group were significantly lower than that before treatment and those of the oral medication group (all P < 0.05). (6) The Hb, Hct, SF, and TSAT levels maintained stable during the period 6, 8, and 12 weeks after treatment in the intravenous iron sucrose group despite the decrease in dose and frequency. (7) The Hb, Hct, SF, and TSAT levels were significantly higher in the intravenous PD subgroup than in the intravenous HD subgroup. (8) No adverse event was found in the intravenous iron sucrose group, and adverse gastrointestinal effects occurred in 12 patients of the oral medication group. (9) After 12 weeks, the cost of EPO + intravenous iron sucrose was significantly higher than that of EPO + ferrous succinate.ConclusionIntravenous iron sucrose effectively increases the serum iron parameters and hemoglobin levels during maintenance peritoneal dialysis and is well tolerated. Infusing intravenous iron sucrose 200 mg every two weeks can maintain the serum iron parameters and hemoglobin level in maintenance peritoneal dialysis patients and n permits reduction of the required dose of EPO. However, the total cost of intravenous iron treatment is relatively high.
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