Initial experience with the modified extracorporeal liver-assist device for patients with fulminant hepatic failure: System modifications and clinical impact
Initial experience with the modified extracorporeal liver-assist device for patients with fulminant hepatic failure: System modifications and clinical impact
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DOI：
10.1097/01.tp.0000038483.93833.21
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发表时间：
2002-12-27
期刊：
影响因子：
6.2
通讯作者：
Maguire, P
中科院分区：
文献类型：
--
作者：
Millis, JM;Cronin, DC;Maguire, P
背景。为暴发性肝衰竭（FHP）患者寻找一种安全、有效的肝支持系统的需求仍未得到满足。使用永生化人肝细胞的系统最初是在20世纪90年代初开发的。最初的体外肝脏辅助装置（ELAD）的改进版本最近在芝加哥大学进行了初步临床试验。本研究的目的是确定该装置在一个中心的安全性，然后将研究范围扩大到其他地点。诊断为FHF并被芝加哥大学录取的患者符合ELAD研究的条件。患者获得知情同意，并在移植前和整个移植过程中接受持续的ELAD治疗。前瞻性地收集数据并随后进行分析。5名患者接受了该装置的治疗。所有患者均成功接受了移植。5名患者中有4名活到了30天的研究终点。没有发现生物力学问题。治疗期间患者血流动力学状况未见恶化。与ELAD连接后，成年患者的临床病程趋于稳定（平均动脉压范围80 ~ 97，平均88.6；脑灌注压范围62 ~ 88，平均76.5）。患者4在ELAD治疗期间有显著改善：消除苯肾上腺素，多巴胺从20马克杯/分钟降至5马克杯/分钟，呼吸支持从100% O-2, 10厘米呼气末正压降至60% O-2, 5厘米呼气末正压。在整个研究期间，该装置继续具有代谢活性，通过氧气使用记录（所有接受治疗的患者从药筒前取样口到药筒后取样口的平均O-2变化= 55 mm Hg）。患者对ELAD治疗耐受性良好。没有意外的安全问题。墨盒中的细胞具有代谢活性。所有患者均成功接受了移植。单机构试验的结果表明，应该进行更大规模的随机多中心试验。
Background. The need to find a safe, effective liver support system for patients with fulminant hepatic failure (FHP) continues to be unmet. A system using immortalized human hepatocytes was originally developed in the early 1990s. A modified version of the initial extracorporeal liver-assist device (ELAD) was recently placed into an initial clinical trial at the University of Chicago. The goal of this study was to determine the safety profile of the device at one center before broadening the study to other sites.Methods. Patients who were diagnosed with FHF and admitted to the University of Chicago were eligible for the ELAD study. Informed consent was obtained, and patients received continuous ELAD therapy until and throughout transplantation. Data were prospectively collected and subsequently analyzed.Results. Five patients were treated with the device. All patients successfully underwent transplantation. Four of the five patients survived to the 30-day end-point of the study. There were no biomechanical problems identified. The patients' hemodynamic conditions did not deteriorate during treatment. The adult patients' clinical courses appeared to stabilize while connected to the ELAD (mean arterial pressure range 80-97, mean 88.6; cerebral perfusion pressure range 62-88, mean 76.5). Patient 4 experienced remarkable improvement during ELAD therapy: elimination of phenylephrine, reduction of dopamine from 20 mug/min to 5 mug/min, and reduction of respiratory support from 100% O-2, 10 cm positive end-expiratory pressure to 60% O-2, and 5 cm H2O positive end-expiratory pressure. The device continued to be metabolically active throughout the study period as documented by oxygen use (mean O-2 change from sampling port before cartridge to sampling port after cartridge for all patients treated = 55 mm Hg).Conclusions. The patients tolerated treatment with the ELAD well. There were no unanticipated safety issues. The cells in the cartridges were metabolically active. All patients successfully underwent transplantation. The results from this single-institution experience indicates that larger randomized multicenter trials should proceed.