对乙酰氨基酚致肝损伤机制的NRCT临床研究

Yawo M Akrodou
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引用次数: 0

摘要

对乙酰氨基酚(n -乙酰基-对氨基酚)是一种化学分子,在扑热息痛药物中用于缓解疼痛和退烧。美国食品和药物管理局(FDA)咨询小组在2009年6月警告说,由于APAP的副作用,包括药物性肝病,APAP过量使用的风险很大。此外,FDA已经开始了多中心非干预性病例对照研究,以收集儿童和青少年APAP毒性生物标志物的数据。FDA下属的国家毒理学研究中心(NCTR)与美国各地的其他卫生机构(医院、大学和临床中心)合作,协调APAP临床试验的执行。这些临床试验的目标是收集足够的数据,以创建与对乙酰氨基酚毒性相关的生物标志物列表,这些生物标志物可以与特定的加合物蛋白相匹配;这些信息可以用来检查和预测服用对乙酰氨基酚的儿童未来的危害。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
NRCT Clinical Study in to Identify Acetaminophen-Induced Liver Injury Mechanism
Acetaminophen (APAP) (N-acetyl-p-aminophenol) is a chemical molecule used to relieve pain and lower fever in paracetamol medications. The Food and Drug Administration (FDA) advisory group warned in June 2009 about the risk of APAP overdose due to its side effects, which include drug-induced liver disease. In addition, the FDA has begun multicenter non-interventional case-control studies to collect data on APAP toxicity biomarkers in children and adolescents. The National Center for Toxicological Research (NCTR), which is part of the FDA, coordinates the execution of APAP clinical trials in collaboration with other health institutes (hospitals, universities, and clinical centres) around the United States. The goal of these clinical trials is to gather enough data to create a list of biomarkers connected to acetaminophen toxicity that can be matched with specific adduct proteins; this information can then be used to examine and predict future hazards in children who are taking acetaminophen.
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