用nR改良海氏法则及PALT评估药物性肝损伤研究进展

Assessment of drug-induced liver injury via nR modified Hy’s law and P_(ALT)

与药物、草药和其他补充或替代疗法相关的肝毒性一直是全球安全专业人员和监管机构关注的问题。在临床开发和上市后阶段及时识别肝损伤仍是一项挑战。目前,用于识别最有可能发展为肝衰竭或死亡的肝毒性病例标准已经取得最新进展,并建立了可用于评估与肝损伤相关肝细胞损失程度的新方法。本文将对这些新方法及其在相关肝毒性持续监测和评估中的应用进行回顾。

Hepatotoxicity associated with drugs,herbal medications and other complementary or alternative therapies has been a global concern for safety professionals and regulatory authorities.Instant identification of liver injury remains a challenge during both clinical development and in the post-marketing period.Advances have been made in the criteria used to identify cases of hepatotoxicity that are most likely to progress to liver failure or death.In addition,new methods are available to estimate the magnitude of hepatocyte loss associated with liver injury.This paper reviews these new methodologies and their applications to the ongoing monitoring and evaluation of product-related hepatoxicity.