铁指标和静脉注射铁氧体：达到稳态的时间。

Iron indices and intravenous ferumoxytol: time to steady-state.

机构信息

University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, USA.

出版信息

Ann Pharmacother. 2012 Oct;46(10):1308-14. doi: 10.1345/aph.1Q614. Epub 2012 Sep 11.

DOI:10.1345/aph.1Q614

PMID:22968523

Abstract

BACKGROUND

The ongoing nature of iron loss in patients receiving hemodialysis makes it difficult to maintain adequate iron stores without supplementation. The effects of ferumoxytol on iron indices have been measured 35 days after baseline, but no study has assessed indices at earlier points in time.

OBJECTIVE

To evaluate the time to transferrin saturation (TSAT) and ferritin stabilization, the point at which TSAT and serum ferritin levels can be accurately measured during a 13-treatment period following a loading dose of ferumoxytol.

METHODS

Ferumoxytol was administered according to the package insert to 15 adults undergoing hemodialysis. Vital signs were recorded before treatment, 30 and 60 minutes after receiving ferumoxytol, and at the end of treatment to monitor for adverse reactions and hemodynamic instability. Monitoring continued for a 13-treatment period (30 days) after drug administration. Blood was collected throughout the study to measure TSAT, ferritin, hemoglobin (Hb), and C-reactive protein (CRP).

RESULTS

TSAT values at 14, 21, and 28 days after drug administration were not significantly different from those at 7 days, signifying that TSAT values stabilized by day 7. Serum ferritin values at day 14 were significantly lower than those 7 days after drug administration (p = 0.028). Although serum ferritin values at days 21 and 28 tended to decrease relative to values at day 14, the differences were not statistically significant. Therefore, it appears that serum ferritin stabilized by day 14 after drug administration. Mean (SD) Hb values at screening and at end of the study were 11.7 (1.0) g/dL and 12.0 (0.9) g/dL, respectively (p = NS). CRP also did not change significantly throughout the study period.

CONCLUSIONS

Dialysis patients achieve stable iron indices quickly. TSAT stabilized by day 7 and ferritin stabilized 14 days after a loading dose of ferumoxytol 1 g. Adverse effects were minimal and did not necessitate discontinuation of ferumoxytol.

摘要

背景

接受血液透析的患者铁元素持续流失，因此如果不进行补充，很难维持充足的铁储存量。已有研究测量了患者接受基线治疗后 35 天铁剂相关指标的变化，但尚无研究评估更早时间点的指标变化情况。

目的

评估转铁蛋白饱和度（TSAT）和铁蛋白稳定所需的时间，即在接受负荷剂量的 ferumoxytol 后 13 次治疗期间，何时能够准确测量 TSAT 和血清铁蛋白水平。

方法

15 名接受血液透析的成年人根据说明书接受 ferumoxytol 治疗。在治疗前、接受 ferumoxytol 后 30 分钟和 60 分钟以及治疗结束时记录生命体征，以监测不良反应和血流动力学不稳定情况。药物治疗结束后继续监测 13 次治疗（30 天）。在整个研究过程中采集血液以测量 TSAT、铁蛋白、血红蛋白（Hb）和 C 反应蛋白（CRP）。

结果

药物治疗后 14、21 和 28 天的 TSAT 值与 7 天的 TSAT 值无显著差异，表明 TSAT 值在第 7 天稳定。药物治疗后 14 天的血清铁蛋白值明显低于治疗后 7 天（p = 0.028）。尽管药物治疗后 14、21 和 28 天的血清铁蛋白值与 14 天的血清铁蛋白值相比有下降趋势，但差异无统计学意义。因此，血清铁蛋白似乎在药物治疗后 14 天稳定。筛选时和研究结束时的平均（SD）Hb 值分别为 11.7（1.0）g/dL 和 12.0（0.9）g/dL（p = NS）。CRP 也在整个研究期间无明显变化。