维持非贫血慢性肾脏病患者的铁指标高于生理范围与维持生理铁指标的随机对照试验。

Maintenance of elevated versus physiological iron indices in non-anaemic patients with chronic kidney disease: a randomized controlled trial.

机构信息

Department of Renal Medicine, Eastern Health, Melbourne, Victoria, Australia.

出版信息

Nephrol Dial Transplant. 2010 Mar;25(3):920-6. doi: 10.1093/ndt/gfp584. Epub 2009 Nov 10.

DOI:10.1093/ndt/gfp584

PMID:19906658

Abstract

BACKGROUND

An optimal haemoglobin (Hb) response to erythropoietin requires elevated iron indices in dialysis patients; however, it is unknown if the same applies in chronic kidney disease (CKD).

METHODS

One hundred patients [CKD Stages 3-5, Hb >or= 110 g/L, iron replete, erythropoietin-stimulating agent (ESA)-naive, 47% diabetic, median age 69.5 years] were block-randomized in an open-label study to receive up to 200 mg intravenous iron sucrose (Group A, n = 52) bimonthly or oral iron sulphate (Group B) to maintain raised and normal iron indices (respectively) over 12 months. The primary endpoint was the change in Hb concentration at 12 months or at termination after at least 6 months of treatment.

RESULTS

Eighty-five patients reached the primary endpoint (43, Group A; 42, Group B). Initial Hb was 119 +/- 7 vs 116 +/- 12 g/L (mean +/- standard deviation); ferritin 122 (71-176), median (inter-quartile range), vs 90 microg/L (58-150); transferrin saturation (TSat) 22 (18-26) vs 21% (15-24); and creatinine 240 (195-313) vs 230 micromol/L (184-352). Ferritin and TSat differed by month 2 [157 (103-220) vs 96 microg/L (73-162), P = 0.003] and month 6 [25 (20-31) vs 21% (17-27), P = 0.02], respectively. At study end, Hb did not differ between groups (121 +/- 10 vs 117 +/- 13 g/L). Ferritin was 362 (310-458) vs 125 microg/L (84-190), P < 0.001; TSat 30 (23-34) vs 21% (18-24), P < 0.001; and creatinine 229 (188-326) vs 272 micromol/L (195-413), P = NS. For patients (Groups A and B, n = 27 in each group) whose creatinine regression slope increased (indicating worsening function), the fall in Hb over 12 months also did not differ between groups despite adequate separation in iron indices. Serious adverse events overall did not differ between groups.

CONCLUSIONS

Elevated iron indices did not increase Hb synthesis in ESA-naive, iron replete, pre-dialysis patients with Hb >110 g/L.

摘要

背景

促红细胞生成素需要升高的铁指标才能使透析患者产生最佳的血红蛋白（Hb）反应；然而，在慢性肾脏病（CKD）患者中是否同样适用尚不清楚。

方法

100 例患者[CKD 分期 3-5 期，Hb≥110g/L，铁充足，未使用促红细胞生成素刺激剂（ESA），47%为糖尿病患者，中位年龄 69.5 岁]按开放标签研究分为两组，每组 50 例，接受静脉注射蔗糖铁（200mg，每 2 月 1 次，A 组）或口服硫酸亚铁（B 组），以在 12 个月内维持升高和正常的铁指标。主要终点是 12 个月时或至少 6 个月治疗后终止时 Hb 浓度的变化。

结果

85 例患者达到主要终点（A 组 43 例，B 组 42 例）。初始 Hb 为 119±7 与 116±12g/L（均值±标准差）；铁蛋白分别为 122（71-176）与 90μg/L（58-150）；转铁蛋白饱和度（TSat）分别为 22（18-26）与 21%（15-24）；肌酐分别为 240（195-313）与 230μmol/L（184-352）。铁蛋白和 TSat 在第 2 个月[157（103-220）与 96μg/L（73-162），P=0.003]和第 6 个月[25（20-31）与 21%（17-27），P=0.02]分别有差异。研究结束时，两组 Hb 无差异（121±10 与 117±13g/L）。铁蛋白分别为 362（310-458）与 125μg/L（84-190），P＜0.001；TSat 分别为 30（23-34）与 21%（18-24），P＜0.001；肌酐分别为 229（188-326）与 272μmol/L（195-413），P=NS。对于肌酐回归斜率增加（提示肾功能恶化）的患者（每组 27 例），尽管铁指标有明显差异，但 12 个月时 Hb 下降在两组之间没有差异。两组总体严重不良事件无差异。