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: 7605100
• 负责人: MICHAEL R. NARKEWICZ
• 金额: $ 0.55万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605100
• 关键词: Acetaminophen; Acetylcysteine; Acute Liver Failure; Adult; Antidotes; Canada; Child; Computer Retrieval of Information on Scientific Projects Database; Europe; Funding; Grant; Institution; Intravenous; Intravenous infusion procedures; Liver; Observational Study; Outcome; Overdose; Pharmaceutical Preparations; Purpose; Research; Research Personnel; Resources; Safety; Source; Testing; Tylenol; United States National Institutes of Health; base; day; improved; intravenous administration; liver transplantation; programs

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是测试静脉注射 N-乙酰半胱氨酸 (NAC) 的药物是否可以改善非对乙酰氨基酚引起的急性肝衰竭 (ALF) 儿童的生存率。 NAC 治疗的最初基础是对对乙酰氨基酚 (Tylenol) 过量的受试者所显示的益处。根据这一初步观察，在成人中进行的不受控制的观察性研究表明，NAC 可能会改善由对乙酰氨基酚以外的原因引起的 ALF 的结果。 NAC 可以帮助肝脏从各种损伤中恢复过来。 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 尚未在美国针对非对乙酰氨基酚 ALF 进行测试或批准。 这项研究是一项国家计划的一部分，该计划旨在测试静脉注射 NAC (IV-NAC) 对于非对乙酰氨基酚引起的 ALF 儿童的价值。将研究对于没有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、有效性以及总体 1 年生存率（有或没有肝移植）。