Department of Nephrology, Kasturba Medical College, Manipal, Karnataka,India.
BMC Nephrol. 2013 Mar 20;14:64. doi: 10.1186/1471-2369-14-64.
Anemia secondary to iron deficiency is common in patients with non-dialysis dependent chronic kidney disease (ND-CKD) but it is unclear if oral supplementation is as effective as intravenous (IV) supplementation in re-establishing iron stores. The purpose of this study was to determine if oral Heme Iron Polypeptide (HIP) is as effective as IV iron sucrose in the treatment of iron-deficiency anemia for patients with ND-CKD.
Forty ND-CKD patients were randomized; 18 to HIP 11 mg orally 3 times per day and 22 to IV iron sucrose 200 mg monthly for 6 months. Baseline clinical and laboratory data were collected for all patients. The primary and secondary outcomes for the study were hemoglobin (Hgb) concentration and iron indices [ferritin and percentage transferrin saturation (TSAT)] at the end of 6 months respectively. Adverse events were also compared.
The baseline demographic characteristics and laboratory values were similar for the two groups. After 6 months of treatment, Hb in the HIP group was 117 g/L and 113 g/L in the IV sucrose group (p = 0.37). The TSAT at 6 months was not different between the two groups {p = 0.82}but the serum ferritin was significantly higher in the IV iron sucrose group {85.5 ug/L in HIP and 244 ug/L; p = 0.004}. Overall adverse events were not different between the groups.
HIP is similar in efficacy to IV iron sucrose in maintaining hemoglobin in ND-CKD patients with no differences in adverse events over 6 months. It is unclear if the greater ferritin values in the IV iron sucrose group are clinically significant.
ClinicalTrials.gov: NCT00318812.
非透析依赖性慢性肾脏病（ND-CKD）患者常出现缺铁性贫血，但目前尚不清楚口服补充剂与静脉（IV）补充剂在重新建立铁储存方面是否同样有效。本研究旨在确定口服血红素多肽（HIP）与静脉铁蔗糖在治疗 ND-CKD 患者缺铁性贫血方面是否同样有效。
40 名 ND-CKD 患者被随机分为 HIP 组（18 名患者，每天口服 HIP 11mg，分 3 次）和 IV 铁蔗糖组（22 名患者，每月静脉注射 IV 铁蔗糖 200mg，共 6 个月）。所有患者均采集基线临床和实验室数据。该研究的主要和次要终点分别为 6 个月时的血红蛋白（Hgb）浓度和铁指标（铁蛋白和转铁蛋白饱和度百分比（TSAT））。还比较了不良反应。
两组患者的基线人口统计学特征和实验室值相似。治疗 6 个月后，HIP 组的 Hgb 为 117g/L，IV 蔗糖组为 113g/L（p=0.37）。两组的 TSAT 在 6 个月时无差异（p=0.82），但 IV 铁蔗糖组的血清铁蛋白明显更高{HIP 组为 85.5ug/L，IV 铁蔗糖组为 244ug/L；p=0.004}。两组的总体不良事件无差异。
HIP 在维持 ND-CKD 患者的血红蛋白方面与 IV 铁蔗糖相似，在 6 个月内不良事件无差异。IV 铁蔗糖组铁蛋白值较高是否具有临床意义尚不清楚。
ClinicalTrials.gov：NCT00318812。
