Feasibility study of cytokine removal by hemoadsorption in brain-dead humans*
Feasibility study of cytokine removal by hemoadsorption in brain-dead humans*
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通过血液吸附去除脑死亡人类细胞因子的可行性研究*
作者：
J. Kellum;R. Venkataraman;D. Powner;M. Elder;G. Hergenroeder;M. Carter
背景：脑死亡后，炎性细胞因子存在于循环和组织中，并与移植前后供体器官的功能障碍有关。目的：探讨血液吸附装置去除细胞因子的可行性。设计：双中心、随机、开放标签、可行性研究，将脑死亡受试者随机分配至两个治疗组。地点：两所美国学术医院。受试者：8名脑死亡受试者，均被各自的器官获取组织认为不适合器官捐献。主要结局指标：在获得家属同意后，使用CytoSorb对受试者进行4小时的血液吸附治疗。随着时间的推移，评估了器械和血浆中对细胞因子（肿瘤坏死因子、白细胞介素[IL]-6和IL-10）的影响。使用客观标准评估细胞因子清除的可行性。结果：CytoSorb器械的细胞因子清除率范围为4%-30%，1小时至4小时无显著差异。IL-6的总清除率最高，为28%（p = 0.006），肿瘤坏死因子的总清除率最低，为8.5%（p = 0.13）。在治疗的第一个小时后，IL-6和肿瘤坏死因子的血浆浓度显著降低，但IL-10的血浆浓度没有显著降低; IL-6的平均差异为-13% ± 7%（p = 0.039），肿瘤坏死因子的平均差异为-23% ± 9%（p = 0.02），IL-10的平均差异为-2% ± 7%（p = 23）。然而，所有三种细胞因子的血浆浓度随时间增加，并且在干预结束时高于基线。未观察到治疗的不良反应。然而，皮质醇和三碘甲腺原氨酸的去除与细胞因子的去除相似。结论：血液吸附用于脑死亡患者细胞因子的清除是可行的。对可能的临床获益的评估需要在实际供体中进行对照试验。然而，细胞因子清除的显著能力和无不良事件表明此类试验是必要的。
Background:Inflammatory cytokines occur in the circulation and in the tissues after brain death and have been associated with dysfunction of donor organs before and after transplantation. Objective:To determine the feasibility of removing cytokines using a hemoadsorption device. Design:Two-center, randomized, open-label, feasibility study in which brain-dead subjects were randomized to two treatment groups. Setting:Two U.S. academic hospitals. Participants:Eight brain-dead subjects deemed unsuitable for organ donation by respective organ procurement organizations. Main Outcome Measures:After obtaining consent from families, subjects were treated with hemoadsorption for 4 hrs using CytoSorb. Effects on cytokines (tumor necrosis factor, interleukin [IL]-6, and IL-10) were assessed both across the device and in the plasma over time. Feasibility for cytokine removal was assessed using objective criteria. Results:Cytokine removal across the CytoSorb device ranged from 4% to 30% and was not significantly different from 1 hr to 4 hrs. Overall removal was greatest for IL-6, 28% (p = .006), and least for tumor necrosis factor, 8.5% (p = .13). Plasma concentrations of both IL-6 and tumor necrosis factor, but not IL-10, were significantly reduced after the first hour of therapy; mean differences were −13% ± 7% for IL-6 (p = .039), −23% ± 9% for tumor necrosis factor (p = .02), and −2% ± 7% of IL-10 (p = 23). However, plasma concentrations for all three cytokines increased over time and were above baseline by the end of the intervention. No adverse effects of therapy were observed. However, removal of cortisol and triiodothyronine was similar to removal of cytokines. Conclusions:Hemoadsorption for removal of cytokines in brain-dead subjects is feasible. Evaluation of possible clinical benefit will require controlled trials in actual donors. However, the significant capacity for cytokine removal and absence of adverse events suggest that such trials are warranted.
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