Division of Nephrology, Department of Medicine, Faculty of Medicine, Thammasat University, Pathumthani, 12120, Thailand.
Chulabhorn International College of Medicine, Thammasat University, Pathumthani, 12120, Thailand.
Sci Rep. 2023 Jan 23;13(1):1287. doi: 10.1038/s41598-023-28440-3.
In patients on chronic hemodialysis, there is no standard protocol for maintenance iron supplementation. This study aimed to compare two fixed-dose intravenous (IV) iron protocols to reduce erythropoiesis-stimulating agents (ESA). We conducted a double-blinded, randomized controlled study on hemodialysis patients having ferritin levels between 200 and 700 ng/dl and transferrin saturation values between 20 and 40%. Patients were assigned to receive either 100 or 200 mg of IV iron each month. ESA was adjusted every month to keep Hb between 10 and 12 g/dl. ESA dose at 12 months was the primary outcome. The secondary outcomes were all-cause mortality, cardiovascular events, absolute iron deficiency anemia (IDA), blood transfusion, adverse events, and iron withholding rate. Of the 79 eligible patients, 40 received 100 mg of IV iron, while 39 received 200 mg. At month 12, the mean monthly ESA dose in the 100-mg IV iron group was 35,706 ± 21,637 IU, compared to 26,382 ± 14,983 IU in the 200-mg group (P = 0.03). IDA was found in twelve patients (30%) in the 100-mg group and four patients (10.5%) in the 200-mg group (P = 0.05). In each group, three patients died (P = 0.9). Hospitalization, venous access thrombosis, and infection rates were similar in both groups. The withholding rate of IV iron was higher in 200-mg group (25% vs. 64.1%), but the protocol compliance was found more in 100-mg group (50% vs. 28.2%) (P = 0.001). In conclusion, monthly 200-mg IV iron infusions significantly reduce ESA doses but have a higher withholding rate. (Funded by the Kidney Foundation of Thailand and the Research Group in Nephrology and Renal Replacement Therapy from the Faculty of Medicine, Thammasat University).Thai Clinical Trials Registry number, TCTR20190707001.
在接受慢性血液透析的患者中，没有标准的维持铁补充方案。本研究旨在比较两种固定剂量的静脉（IV）铁方案，以减少红细胞生成刺激剂（ESA）的使用。我们对铁蛋白水平在 200 至 700ng/dl 之间且转铁蛋白饱和度值在 20 至 40%之间的血液透析患者进行了一项双盲、随机对照研究。患者被分配每月接受 100 或 200mg 的 IV 铁治疗。每个月调整 ESA 的剂量以保持 Hb 在 10 至 12g/dl 之间。12 个月时的 ESA 剂量为主要结局。次要结局包括全因死亡率、心血管事件、绝对缺铁性贫血（IDA）、输血、不良事件和铁剂停药率。在 79 名符合条件的患者中，40 名患者接受 100mg 的 IV 铁治疗，39 名患者接受 200mg 的 IV 铁治疗。在第 12 个月时，100mg IV 铁组的平均每月 ESA 剂量为 35706±21637IU，而 200mg 组为 26382±14983IU（P=0.03）。100mg 组有 12 名患者（30%）出现 IDA，而 200mg 组有 4 名患者（10.5%）出现 IDA（P=0.05）。每个组各有 3 名患者死亡（P=0.9）。两组的住院率、静脉通路血栓形成和感染率相似。200mg 组的 IV 铁停药率较高（25% vs. 64.1%），但 100mg 组的方案依从性较高（50% vs. 28.2%）（P=0.001）。总之，每月 200mg IV 铁输注可显著减少 ESA 剂量，但停药率较高。（由泰国肾脏基金会和玛希隆大学医学院肾脏病学和肾脏替代治疗研究组资助）。泰国临床试验注册中心编号，TCTR20190707001。
