hemoglobin stability and erythropoiesis-stimulating agent utilization. Background Anemia is common among patients on hemodialysis. Maintaining stable hemoglobin levels within predefined target levels can be challenging, particularly in patients with frequent hemoglobin fluctuations both above and below the desired targets. We conducted a multicenter, randomized controlled trial comparing our anemia therapy assistance software against a standard population-based anemia treatment protocol. We hypothesized that personalized dosing of erythropoiesis-stimulating agents (ESAs) improves hemoglobin target attainment. Methods Ninety-six patients undergoing hemodialysis and receiving methoxy polyethylene glycol-epoetin beta were randomized 1:1 to the intervention group (personalized ESA dose recommendations computed by the software) or the standard-of-care group for 26 weeks. The therapy assistance software combined a physiology-based mathematical model and a model predictive controller designed to stabilize hemoglobin levels within a tight target range (10–11 g/dl). The primary outcome measure was the percentage of hemoglobin measurements within the target. Secondary outcome measures included measures of hemoglobin variability and ESA utilization. Results The intervention group showed an improved median percentage of hemoglobin measurements within target at 47% (interquartile range, 39–58), with a 10% point median difference between the two groups (95% confidence interval, 3 to 16; P = 0.008). The odds ratio of being within the hemoglobin target in the standard-of-care group compared with the group receiving the personalized ESA recommendations was 0.68 (95% confidence interval, 0.51 to 0.92). The variability of hemoglobin levels decreased in the intervention group, with the percentage of patients experiencing fluctuating hemoglobin levels being 45% versus 82% in the standard-of-care group. ESA usage was reduced by approximately 25% in the intervention group. Conclusions Our results demonstrated an improved hemoglobin target attainment and variability by using personalized ESA recommendations using the physiology-based anemia therapy assistance software. Clinical Trial registration number: NCT04360902....

中文翻译：

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个体化贫血治疗对血红蛋白稳定性的影响：血液透析患者的随机对照预试验


血红蛋白稳定性和红细胞生成刺激剂的利用。背景 贫血在血液透析患者中​​很常见。将稳定的血红蛋白水平维持在预定的目标水平内可能具有挑战性，特别是对于血红蛋白频繁波动高于和低于预期目标的患者。我们进行了一项多中心、随机对照试验，将我们的贫血治疗辅助软件与基于人群的标准贫血治疗方案进行比较。我们假设红细胞生成刺激剂（ESA）的个性化给药可以改善血红蛋白目标的实现。方法 将 96 名接受血液透析并接受甲氧基聚乙二醇-促红细胞生成素β治疗的患者按 1:1 随机分配到干预组（由软件计算的个性化 ESA 剂量建议）或标准护理组，为期 26 周。该治疗辅助软件结合了基于生理学的数学模型和模型预测控制器，旨在将血红蛋白水平稳定在严格的目标范围内（10-11 g/dl）。主要结果指标是血红蛋白测量值在目标范围内的百分比。次要结果指标包括血红蛋白变异性和 ESA 利用率的指标。结果 干预组显示，血红蛋白测量值在目标范围内的中位百分比提高了 47%（四分位数范围，39-58），两组之间的中位差异为 10%（95% 置信区间，3 至 16；P = 0.008 ）。与接受个性化 ESA 建议的组相比，标准护理组处于血红蛋白目标范围内的优势比为 0.68（95% 置信区间，0.51 至 0.92）。 干预组中血红蛋白水平的变异性降低，出现血红蛋白水平波动的患者比例为 45%，而标准治疗组为 82%。干预组中 ESA 的使用量减少了约 25%。结论 我们的结果表明，通过使用基于生理学的贫血治疗辅助软件的个性化 ESA 建议，可以改善血红蛋白目标的实现和变异性。临床试验注册号：NCT04360902....