Gaweda Adam E, Jacobs Alfred A, Aronoff George R, Brier Michael E
Division of Nephrology, University of Louisville, Louisville, KY 40202, USA.
Am J Kidney Dis. 2008 Jan;51(1):71-9. doi: 10.1053/j.ajkd.2007.10.003.
Variable hemoglobin (Hb) response to erythropoiesis-stimulating agents (ESAs) may result in adverse outcomes. New methods are needed to determine the appropriate dose of ESA to maintain the target Hb level.
(1) Observational study to develop an algorithm for model predictive control (MPC) by using an artificial neural network model of Hb response to ESA. (2) Computer simulation to test MPC versus a conventional anemia management protocol (AMP). (3) Clinical trial to test MPC.
SETTING & PARTICIPANTS: The MPC was developed from historic data from 186 long-term hemodialysis patients at the University of Louisville, KY. Testing by simulation occurred in 60 hypothetical patients generated from random sampling of the 186 patients. The trial included 9 hemodialysis patients who received ESA doses based on MPC recommendations over 6 months.
Management by means of MPC or AMP. OUTCOME OF INTEREST: Achieved Hb level and variability measured by means of the difference between achieved Hb level and target Hb level of 11.5 g/dL and erythropoietin dose. In the trial, Hb level deviation from target was compared in the same subjects between the study (last 4 of 6 months on MPC) and control (4 months on AMP immediately proceeding the study period) periods.
In simulation, achieved Hb levels were 12.3 +/- 0.6 g/dL for AMP and 11.6 +/- 0.4 g/dL for MPC (P < 0.001), mean SDs were 0.75 +/- 0.30 g/dL for AMP and 0.60 +/- 0.21 g/dL for MPC (P < 0.01), and mean absolute differences from target were 0.8 +/- 0.6 g/dL for AMP and 0.3 +/- 0.3 g/dL for MPC (P < 0.001). In the trial, achieved Hb levels were 11.9 +/- 1.1 g/dL for AMP and 11.8 +/- 0.6 g/dL for MPC (P = 0.8), mean SDs were 0.86 +/- 0.60 g/dL for AMP and 0.64 +/- 0.33 g/dL for MPC (P = 0.4), and mean absolute differences from target were 1.19 +/- 0.79 g/dL for AMP and 0.79 +/- 0.50 g/dL for MPC (P = 0.02).
MPC of ESAs may result in improved anemia management.
血红蛋白（Hb）对促红细胞生成素（ESA）的反应存在差异，这可能导致不良后果。需要新的方法来确定合适的ESA剂量，以维持目标Hb水平。
（1）观察性研究，通过使用Hb对ESA反应的人工神经网络模型来开发模型预测控制（MPC）算法。（2）计算机模拟，用于测试MPC与传统贫血管理方案（AMP）。（3）临床试验，用于测试MPC。
MPC是根据肯塔基州路易斯维尔大学186例长期血液透析患者的历史数据开发的。通过模拟进行测试的对象是从这186例患者中随机抽样产生的60例虚拟患者。该试验纳入了9例血液透析患者，他们在6个月内根据MPC建议接受ESA剂量。
采用MPC或AMP进行管理。感兴趣的结果：达到的Hb水平以及通过达到的Hb水平与目标Hb水平11.5g/dL之间的差异和促红细胞生成素剂量来衡量的变异性。在试验中，比较了同一受试者在研究期（MPC治疗的6个月中的最后4个月）和对照期（研究期之前立即接受4个月AMP治疗）的Hb水平与目标值的偏差。
在模拟中，AMP组达到的Hb水平为12.3±0.6g/dL，MPC组为11.6±0.4g/dL（P<0.001）；AMP组的平均标准差为0.75±0.30g/dL，MPC组为0.60±0.21g/dL（P<0.01）；AMP组与目标值的平均绝对差异为0.8±0.6g/dL，MPC组为0.3±0.3g/dL（P<0.001）。在试验中，AMP组达到的Hb水平为11.9±1.1g/dL，MPC组为11.8±0.6g/dL（P=0.8）；AMP组的平均标准差为0.86±0.60g/dL，MPC组为0.64±0.33g/dL（P=0.4）；AMP组与目标值的平均绝对差异为1.19±0.79g/dL，MPC组为0.79±0.50g/dL（P=0.02）。
ESA的MPC可能会改善贫血管理。
