Dialysis and Transplantation Center, Parhon University Hospital, Laşi, Romania.
Nephrol Dial Transplant. 2010 Aug;25(8):2722-30. doi: 10.1093/ndt/gfq069. Epub 2010 Feb 26.
Patients with chronic kidney disease (CKD) often present with iron depletion and iron deficiency anaemia (IDA) because of frequent blood (and iron) loss. Therapy consists of repletion of iron stores and intravenous (i.v.) iron has become the standard care in this setting. However, older i.v. iron preparations have their limitations. This study primarily investigated the safety, and also the efficacy, of ferric carboxymaltose (FCM), a next-generation i.v. iron formulation, given as a bolus-push injection in patients with CKD undergoing maintenance haemodialysis (HD).
Patients (aged 18-65 years) with IDA undergoing HD received 100-200 mg of iron as FCM via an i.v. bolus-push injection into the HD venous line, two to three times weekly for <or=6 weeks. Safety assessments included incidence of adverse events (AEs). Treatment responders were patients attaining >or=1.0 g/dl increase in haemoglobin (Hb) from baseline at any time during the study. Enrolled patients (safety population) receiving >or=1 dose of study medication were included in the efficacy analyses [intent-to-treat (ITT) population].
Of 163 patients enrolled, 150 (92%) completed the study. The mean +/- SD total cumulative dose of iron as FCM administered was 2133.3 +/- 57.7 mg. In total, 193 AEs were reported in 89 out of 163 (54.6%) patients. Almost three-quarters of patients (73.6%) received erythropoiesis-stimulating agents (ESAs), but the dose remained stable during the study. Serious AEs occurred in 12 out of 163 (7.4%) patients and two patients died; none of these was considered by the investigator to be related to the study medication. Only five out of 163 (3.1%) patients discontinued study medication due to an AE. Overall, 100 out of 162 (61.7%; ITT population) patients were treatment responders, and mean Hb levels increased from 9.1 +/- 1.30 g/dl at baseline to 10.3 +/- 1.63 g/dl at follow-up.
FCM is well-tolerated and effective in the correction of Hb levels and iron stores in patients with IDA undergoing HD. As changes in anaemia treatment other than i.v. FCM (e.g. increased ESA doses) were not permitted during the study, the clinically relevant increase in Hb in the majority of patients can be solely attributed to efficient iron utilization. The incidence of AEs was as expected for this population.
慢性肾脏病（CKD）患者常因频繁失血（和铁）而出现缺铁和缺铁性贫血（IDA）。治疗包括补充铁储存，静脉（iv）铁已成为该情况下的标准治疗。然而，较旧的 iv 铁制剂有其局限性。本研究主要考察了铁羧麦芽糖（FCM）的安全性，以及在接受维持性血液透析（HD）的 CKD 患者中，作为静脉推注给予的新一代 iv 铁制剂的疗效。
接受 IDA 治疗且正在接受 HD 的患者（18-65 岁）通过静脉内（iv）推注将 100-200mg 的铁给予 FCM，每周 2-3 次，持续 6 周。安全性评估包括不良事件（AE）的发生率。在研究期间任何时候血红蛋白（Hb）从基线增加≥1.0g/dl 的患者被视为治疗应答者。接受≥1 剂研究药物的入组患者（安全性人群）被纳入疗效分析[意向治疗（ITT）人群]。
在 163 名入组患者中，150 名（92%）完成了研究。给予 FCM 的总累积铁剂量的平均值±SD 为 2133.3±57.7mg。共有 193 例不良事件报告发生于 163 例患者中的 89 例（54.6%）。近 3/4 的患者（73.6%）接受了促红细胞生成素刺激剂（ESA）治疗，但在研究期间ESA 剂量保持稳定。163 例患者中有 12 例（7.4%）发生严重不良事件，有 2 例患者死亡；研究者认为这些均与研究药物无关。由于 AE，163 例患者中有 5 例（3.1%）停止使用研究药物。总体而言，162 例患者中有 100 例（61.7%；ITT 人群）为治疗应答者，Hb 水平从基线时的 9.1±1.30g/dl 增加到随访时的 10.3±1.63g/dl。
FCM 在接受 HD 的 IDA 患者中纠正 Hb 水平和铁储存方面具有良好的耐受性和疗效。由于研究期间不允许除 iv FCM 以外的贫血治疗方法（如增加 ESA 剂量）发生变化，因此大多数患者的 Hb 水平的临床相关增加可归因于铁的有效利用。AE 的发生率与该人群预期的一致。
