Mazariegos George V, Patzer John F, Lopez Roberto C, Giraldo Mauricio, Devera Michael E, Grogan Tracy A, Zhu Yue, Fulmer Melissa L, Amiot Bruce P, Kramer David J
Thomas E Starzl Transplantation Institute, Department of Surgery, University of Pittsburgh, PA, USA.
Am J Transplant. 2002 Mar;2(3):260-6. doi: 10.1034/j.1600-6143.2002.20311.x.
The first clinical use of the Excorp Medical Bioartificial Liver Support System (BLSS) in support of a 41-year-old African-American female with fulminant hepatic failure is described. The BLSS is currently in a Phase I/II safety evaluation at the University of Pittsburgh/UPMC System. Inclusion criteria for the study are patients with acute liver failure, any etiology, presenting with encephalopathy deteriorating beyond Parson's Grade 2. The BLSS consists of a blood pump; a heat exchanger to control blood temperature; an oxygenator to control oxygenation and pH; a bioreactor; and associated pressure and flow alarm systems. Patient liver support is provided by 70-100 g of porcine liver cells housed in the hollow fiber bioreactor. The patient exhibited transient hypotension and thrombocytopenia at initiation of perfusion. The only unanticipated safety event was a lowering of patient glucose level at the onset of perfusion with the BLSS that was treatable with intravenous glucose administration. Moderate changes in blood biochemistries pre- and post perfusion are indicative of liver support being provided by the BLSS. While the initial experience with the BLSS is encouraging, completion of the Phase I/II study is required in order to more fully understand the safety aspects of the BLSS.
本文描述了Excorp Medical生物人工肝支持系统（BLSS）首次临床应用于一名41岁暴发性肝衰竭非裔美国女性的情况。目前，BLSS正在匹兹堡大学/匹兹堡大学医学中心系统进行I/II期安全性评估。该研究的纳入标准为任何病因导致的急性肝衰竭患者，且伴有超过帕森斯2级恶化的脑病。BLSS由一个血泵、一个控制血液温度的热交换器、一个控制氧合和pH值的氧合器、一个生物反应器以及相关的压力和流量报警系统组成。患者的肝脏支持由容纳在中空纤维生物反应器中的70 - 100克猪肝细胞提供。患者在灌注开始时出现短暂性低血压和血小板减少。唯一未预料到的安全事件是在使用BLSS灌注开始时患者血糖水平降低，可通过静脉注射葡萄糖治疗。灌注前后血液生化指标的适度变化表明BLSS提供了肝脏支持。虽然BLSS的初步经验令人鼓舞，但仍需要完成I/II期研究，以便更全面地了解BLSS的安全性。
