N-ACETYLCYSTEINE IN TREATMENT OF ACUTE LIVER FAILURE NOT CAUSE BY ACETAMINOPHEN

N-乙酰半胱氨酸治疗非对乙酰氨基酚引起的急性肝衰竭

• 批准号: 7374386
• 负责人: MICHAEL R. NARKEWICZ
• 金额: $ 0.41万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-24 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374386
• 关键词: acetaminophen; children; liver failure

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to test whether a drug called N-Acetylcysteine (NAC) given as an intravenous (in the vein) infusion improves survival for children with acute liver failure (ALF) that is not due to acetaminophen.The initial basis for this treatment with NAC is the benefit demonstrated in subjects with acetaminophen (Tylenol) overdose. From this initial observation, uncontrolled observational studies in adults suggest that NAC may improve the outcome of ALF from causes other than acetaminophen. NAC may help the liver's ability to recover from a variety of insults. IV- NAC is used in Europe and Canada for treatment of acetaminophen overdose induced ALF and non-acetaminophen induced ALF and has recently been approved for this use in acetaminophen overdose in the US. However, IV-NAC has not been tested or approved in the U.S. for non-acetaminophen ALF. This study is part of a national program to test the value of an IV infusion of NAC (IV-NAC) in those children with ALF NOT due to acetaminaphen. Safety and efficacy and overall 1 year survival (with or without liver transplantation) of a 7 day course of intravenous N-Acetylcysteine in children with ALF for whom no antidote or other specific treatment is available will be studied.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是测试一种名为n -乙酰半胱氨酸（NAC）的药物作为静脉输注是否能提高非对乙酰氨基酚引起的急性肝衰竭（ALF）患儿的生存率。NAC治疗的最初基础是对乙酰氨基酚（泰诺）过量的受试者的益处。从这一初步观察结果来看，在成人中进行的非对照观察性研究表明，NAC可能改善非扑热息痛原因引起的ALF的预后。NAC可以帮助肝脏从各种损伤中恢复。IV- NAC在欧洲和加拿大用于治疗对乙酰氨基酚过量诱导的ALF和非对乙酰氨基酚诱导的ALF，最近在美国被批准用于对乙酰氨基酚过量。然而，IV-NAC尚未在美国测试或批准用于非对乙酰氨基酚ALF。本研究是国家项目的一部分，旨在测试对乙酰氨基酚引起的ALF患儿静脉注射NAC （IV-NAC）的价值。将研究无解毒剂或其他特异性治疗的ALF儿童静脉注射n -乙酰半胱氨酸7天疗程的安全性和有效性以及1年总生存率（伴有或不伴有肝移植）。