THE HEPATIX EXTRACORPOREAL LIVER ASSIST DEVICE - INITIAL CLINICAL-EXPERIENCE
THE HEPATIX EXTRACORPOREAL LIVER ASSIST DEVICE - INITIAL CLINICAL-EXPERIENCE
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DOI：
10.1111/j.1525-1594.1994.tb02221.x
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发表时间：
1994-05-01
影响因子：
2.4
通讯作者：
KELLY, JH
中科院分区：
文献类型：
--
作者：
SUSSMAN, NL;GISLASON, GT;KELLY, JH
1991年6月至1993年8月期间，11例患者接受了Hepatix体外肝脏辅助装置（ELAD）治疗。前2例患者根据美国食品药品监督管理局指南（“未经批准的医疗器械的紧急使用”，1985年10月22日）进行治疗，其余9例患者根据试验用器械豁免（IDE）进行治疗。该研究的目标是确定ELAD治疗的短期安全性，重点是急性医学并发症，例如血流动力学不稳定、补体激活和重要器官功能恶化。作为次要目标，评估了ELAD笔芯的代谢能力及其临床影响。如果患者恢复了足够的肝功能，可以在脱离ELAD后存活，或者在原位肝移植前病情稳定，则认为治疗成功。没有短期安全性问题与ELAD使用相关。此外，11例患者中有10例记录了代谢支持，6例患者达到了成功的终点。Hepatix ELAD是安全的，它为晚期肝衰竭患者提供了可测量的代谢支持。这项初步研究为开展ELAD治疗各种终末期肝病的对照试验提供了动力。
Eleven patients were treated with the Hepatix extracorporeal liver assist device (ELAD) between June 1991 and August 1993. The first 2 patients were treated according to Food and Drug Administration guidelines (''Emergency Use of Unapproved Medical Devices,'' October 22, 1985), and the remaining 9 were treated according to an Investigational Device Exemption (IDE). The goal of the study was to establish the short-term safety of ELAD therapy, with a focus on acute medical complications such as hemodynamic instability, complement activation, and deterioration of vital organ function. As secondary goals, the metabolic capacity of ELAD cartridges and their clinical impact were assessed. Treatment was considered successful if the patient recovered sufficient liver function to survive weaning from the ELAD or was stabilized until orthotopic liver transplantation was performed. No short-term safety problems were associated with ELAD use. In addition, metabolic support was documented in 10 of the 11 patients, and 6 patients reached a successful end-point. The Hepatix ELAD is safe, and it provides measurable metabolic support in patients with late-stage liver failure. This pilot study provides the impetus to perform controlled trials of ELAD therapy in the treatment of various types of end-stage liver disease.