Sussman N L, Gislason G T, Conlin C A, Kelly J H
Hepatix Incorporated, Houston, Texas 77082.
Artif Organs. 1994 May;18(5):390-6. doi: 10.1111/j.1525-1594.1994.tb02221.x.
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.
1991年6月至1993年8月期间，11名患者接受了Hepatix体外肝脏辅助装置（ELAD）治疗。前2名患者根据美国食品药品监督管理局的指南（“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名患者根据研究性器械豁免（IDE）进行治疗。该研究的目的是确定ELAD治疗的短期安全性，重点关注急性医学并发症，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滤筒的代谢能力及其临床影响。如果患者恢复了足够的肝功能以在脱离ELAD后存活，或者在进行原位肝移植之前病情稳定，则认为治疗成功。使用ELAD未出现短期安全问题。此外，11名患者中有10名记录到了代谢支持，6名患者达到了成功的终点。Hepatix ELAD是安全的，并且它为晚期肝功能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治疗各种类型终末期肝病的对照试验提供了动力。
