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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的目的是测试一种名为N-乙酰半胱氨酸(NAC)的药物静脉输注是否能提高非对乙酰氨基酚引起的急性肝功能衰竭(ALF)儿童的存活率。NAC治疗的初步依据是在对乙酰氨基酚(Tylenol)过量的受试者中表现出的益处。根据这一初步观察，成人中的非对照观察研究表明，NAC可能会改善由对乙酰氨基酚以外的原因引起的ALF的结局。NAC可能有助于肝脏从各种侮辱中恢复过来。IV-NAC在欧洲和加拿大用于治疗对乙酰氨基酚过量引起的ALF和非对乙酰氨基酚引起的ALF，最近在美国被批准用于治疗对乙酰氨基酚过量。然而，IV-NAC尚未在美国进行非对乙酰氨基酚ALF的测试或批准。这项研究是一项国家计划的一部分，该计划旨在测试静脉输注NAC(IV-NAC)对非对乙酰氨基酚所致ALF儿童的价值。在没有解毒剂或其他特殊治疗方法的ALF儿童中，静脉注射N-乙酰半胱氨酸7天疗程的安全性、有效性和总的1年存活率(有或没有肝移植)将得到研究。