Fuertinger Doris H, Wang Lin-Chun, Jörg David J, Rivera Fuentes Lemuel, Ye Xiaoling, Casper Sabrina, Zhang Hanjie, Mermelstein Ariella, Cherif Alhaji, Ho Kevin, Raimann Jochen G, Tisdale Lela, Kotanko Peter, Thijssen Stephan
Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.
Renal Research Institute, New York, New York.
Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1138-1147. doi: 10.2215/CJN.0000000000000488. Epub 2024 Jun 11.
We conducted a randomized controlled pilot trial in patients on hemodialysis using a physiology-based individualized anemia therapy assistance software. Patients in the group receiving erythropoiesis-stimulating agent dose recommendations from the novel software showed improvement in hemoglobin stability and erythropoiesis-stimulating agent utilization.
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.
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.
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; = 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.
Our results demonstrated an improved hemoglobin target attainment and variability by using personalized ESA recommendations using the physiology-based anemia therapy assistance software.
: NCT04360902.
我们使用基于生理学的个体化贫血治疗辅助软件，对接受血液透析的患者进行了一项随机对照试验。接受该新型软件推荐的促红细胞生成素剂量的组中的患者，血红蛋白稳定性和促红细胞生成素利用率均有所改善。
贫血在血液透析患者中很常见。将血红蛋白水平维持在预定义的目标水平内可能具有挑战性，尤其是在血红蛋白频繁波动于目标值上下的患者中。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。我们假设促红细胞生成素（ESA）的个性化给药可提高血红蛋白目标达成率。
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随机分为干预组（由软件计算的个性化ESA剂量推荐）或标准治疗组，为期26周。治疗辅助软件结合了基于生理学的数学模型和旨在将血红蛋白水平稳定在狭窄目标范围（10 - 11 g/dl）内的模型预测控制器。主要结局指标是目标范围内血红蛋白测量值的百分比。次要结局指标包括血红蛋白变异性和ESA利用率的测量。
干预组目标范围内血红蛋白测量值的中位数百分比提高到47%（四分位间距，39 - 58），两组之间的中位数差异为10个百分点（95%置信区间，3至16；P = 0.008）。与接受个性化ESA推荐的组相比，标准治疗组血红蛋白在目标范围内的比值比为0.68（95%置信区间，0.51至0.92）。干预组血红蛋白水平的变异性降低，血红蛋白水平波动的患者百分比为45%，而标准治疗组为82%。干预组的ESA使用量减少了约25%。
我们的结果表明，使用基于生理学的贫血治疗辅助软件进行个性化ESA推荐可提高血红蛋白目标达成率并降低变异性。
NCT04360902。
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