用 nR 改良海氏法则及 PALT 评估药物性肝损伤研究进展

doi:10.19803/j.1672-8629.20230615

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (1): 117-120.
DOI: 10.19803/j.1672-8629.20230615

• 国际研究进展 • 上一篇

用 nR 改良海氏法则及 P_ALT 评估药物性肝损伤研究进展

詹姆斯·布坎南

CovilanceLLC, 美国加利福尼亚州贝尔蒙特市

收稿日期:2023-09-28 出版日期:2024-01-15 发布日期:2024-01-18
作者简介:詹姆斯·布坎南（JAMES Buchanan）,博士,药品安全及临床毒理。E-mail: Jbuchanan@covilance.com

Assessment of drug-induced liver injury via nR modified Hy’s law and P_ALT

BUCHANAN James

Covilance LLC, Belmont, CA, USA

Received:2023-09-28 Online:2024-01-15 Published:2024-01-18

摘要/Abstract

摘要： 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。

关键词: 药物性肝损伤（DILI）, 草药, 补充疗法, 替代疗法, 海氏法则, 药物引起严重肝毒性的四象限评价图表, R值, nR值, 谷丙转氨酶的P值

Abstract: 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.

Key words: drug-induced liver injury(DILI), herbal medications, complementary therapies, alternative therapies, Hy’s Law, eDISH, R value, nR value, P_ALT

中图分类号:

R969
R994.11

詹姆斯·布坎南. 用 nR 改良海氏法则及 P_ALT 评估药物性肝损伤研究进展[J]. 中国药物警戒, 2024, 21(1): 117-120.

BUCHANAN James. Assessment of drug-induced liver injury via nR modified Hy’s law and P_ALT[J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 117-120.

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用 nR 改良海氏法则及 P_ALT 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

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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 PALT

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用 nR 改良海氏法则及 P_ALT 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