Sloand J A, Shelly M A, Erenstone A L, Schiff M J, Talley T E, Dhakal M P
Department of Medicine, Highland Hospital, University of Rochester School of Medicine and Dentistry, New York 14620, USA.
Perit Dial Int. 1998 Sep-Oct;18(5):522-7.
To determine the safety and efficacy of intravenous total dose iron (TDI) replacement in patients treated with home renal replacement therapy.
Prospective open-label study on end points in the population studied.
Institutional outpatient home dialysis program.
The study included 20 end-stage renal disease (ESRD) patients, performing chronic peritoneal or home hemodialysis, with iron deficiency defined as ferritin < 100 ng/mL and/or an iron saturation < 20%.
The total dose of iron dextran was calculated and infused at a rate not exceeding 6 mg/min. Hemoglobin, hematocrit, iron studies, and liver function tests (LFTs) were obtained before and 3 to 4 weeks after TDI infusion. Hematocrit of patients failing to achieve an increase in Hct over this period was re-examined 2 to 4 weeks later looking for a delayed response.
Primary end points for efficacy were changes in Hct, ferritin, and iron saturation. Toxicity was measured as reported immediate and delayed symptoms and elevated transaminases and/or alkaline phosphatase levels.
A median iron dose of 1000 mg (range, 325-1500 mg) was administered. The infusions were generally well tolerated. Clinical adverse effects were seen in 2 patients weighing less than 50 kg. No increase in LFT results was seen. Hematocrit increased 2.2% (95% CI, 0.5%-3.9%) from 29.0% to 31.2% (p = 0.01) within 4 weeks of infusion. Significant increases also occurred in iron saturation (from 13% to 22%, p = 0.001) and ferritin (from 234 to 305 ng/mL, p = 0.008). Among the 9 patients who did not respond with a significant increase in Hct, 2 had a delayed response, increasing the overall response from 63% at 4 weeks to 71%, 8 weeks after TDI. Inadequate erythropoietin dosing and low-grade infectious/inflammatory disorders may have contributed to a poor response in several patients.
Total dose iron is a safe and effective means of restoring iron and erythropoietic response in ESRD patients weighing more than 50 kg who receive their renal replacement therapy at home.
确定静脉注射全剂量铁剂（TDI）对接受家庭肾脏替代治疗患者的安全性和有效性。
对所研究人群的终点进行前瞻性开放标签研究。
机构门诊家庭透析项目。
该研究纳入了20例终末期肾病（ESRD）患者，这些患者进行慢性腹膜透析或家庭血液透析，缺铁定义为铁蛋白<100 ng/mL和/或铁饱和度<20%。
计算右旋糖酐铁的总剂量，并以不超过6 mg/min的速率输注。在输注TDI前及输注后3至4周获取血红蛋白、血细胞比容、铁代谢指标及肝功能检查（LFTs）结果。在此期间血细胞比容未增加的患者，在2至4周后重新检查，以寻找延迟反应。
疗效的主要终点是血细胞比容、铁蛋白和铁饱和度的变化。毒性通过报告的即时和延迟症状以及转氨酶和/或碱性磷酸酶水平升高来衡量。
中位铁剂量为1000 mg（范围325 - 1500 mg）。输注一般耐受性良好。2例体重小于50 kg的患者出现临床不良反应。肝功能检查结果未见升高。输注后4周内，血细胞比容从29.0%增至31.2%，升高了2.2%（95%CI，0.5% - 3.9%，p = 0.01）。铁饱和度（从13%增至22%，p = 0.001）和铁蛋白（从234增至305 ng/mL，p = 0.008）也显著增加。在9例血细胞比容未显著增加的患者中，2例有延迟反应，使TDI后8周时的总体反应率从4周时的63%增至71%。促红细胞生成素剂量不足和轻度感染/炎症性疾病可能导致部分患者反应不佳。
对于在家接受肾脏替代治疗、体重超过50 kg的ESRD患者，全剂量铁剂是恢复铁和促红细胞生成反应的安全有效方法。
