Department of Medicine and.
J Am Soc Nephrol. 2014 Jan;25(1):159-66. doi: 10.1681/ASN.2013010089. Epub 2013 Sep 12.
One-size-fits-all protocol-based approaches to anemia management with erythropoiesis-stimulating agents (ESAs) may result in undesired patterns of hemoglobin variability. In this single-center, double-blind, randomized controlled trial, we tested the hypothesis that individualized dosing of ESA improves hemoglobin variability over a standard population-based approach. We enrolled 62 hemodialysis patients and followed them over a 12-month period. Patients were randomly assigned to receive ESA doses guided by the Smart Anemia Manager algorithm (treatment) or by a standard protocol (control). Dose recommendations, performed on a monthly basis, were validated by an expert physician anemia manager. The primary outcome was the percentage of hemoglobin concentrations between 10 and 12 g/dl over the follow-up period. A total of 258 of 356 (72.5%) hemoglobin concentrations were between 10 and 12 g/dl in the treatment group, compared with 208 of 336 (61.9%) in the control group; 42 (11.8%) hemoglobin concentrations were <10 g/dl in the treatment group compared with 88 (24.7%) in the control group; and 56 (15.7%) hemoglobin concentrations were >12 g/dl in the treatment group compared with 46 (13.4%) in the control group. The median ESA dosage per patient was 2000 IU/wk in both groups. Five participants received 6 transfusions (21 U) in the treatment group, compared with 8 participants and 13 transfusions (31 U) in the control group. These results suggest that individualized ESA dosing decreases total hemoglobin variability compared with a population protocol-based approach. As hemoglobin levels are declining in hemodialysis patients, decreasing hemoglobin variability may help reduce the risk of transfusions in this population.
一刀切的基于方案的贫血管理方法与促红细胞生成素刺激剂（ESA）可能导致血红蛋白变异性的不良模式。在这项单中心、双盲、随机对照试验中，我们检验了这样一个假设，即 ESA 的个体化剂量可改善血红蛋白变异性，优于基于人群的标准方法。我们纳入了 62 名血液透析患者，并对其进行了为期 12 个月的随访。患者被随机分配接受智能贫血管理算法（治疗）或标准方案（对照）指导的 ESA 剂量。每月进行的剂量建议由一位专家医生贫血管理者进行验证。主要结局是在随访期间，血红蛋白浓度在 10 到 12 g/dl 之间的百分比。在治疗组中，有 258/356（72.5%）的血红蛋白浓度在 10 到 12 g/dl 之间，而在对照组中为 208/336（61.9%）；在治疗组中有 42（11.8%）的血红蛋白浓度<10 g/dl，而在对照组中为 88（24.7%）；在治疗组中有 56（15.7%）的血红蛋白浓度>12 g/dl，而在对照组中为 46（13.4%）。两组患者的平均每周 ESA 剂量为 2000IU。在治疗组中有 5 名患者接受了 6 次输血（21U），而在对照组中有 8 名患者和 13 次输血（31U）。这些结果表明，与基于人群的方案相比，个体化 ESA 剂量可降低总血红蛋白变异性。随着血液透析患者的血红蛋白水平下降，降低血红蛋白变异性可能有助于降低该人群的输血风险。
