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草药性肝毒性的临床与因果关系评估。

Clinical and causality assessment in herbal hepatotoxicity.

机构信息

Academic Teaching Hospital of Goethe University of Frankfurt/Main, Department of Internal Medicine II, Klinikum Hanau, Leimenstrasse 20, D-63450 Hanau, Germany.

出版信息

Expert Opin Drug Saf. 2013 May;12(3):339-66. doi: 10.1517/14740338.2013.774371. Epub 2013 Mar 5.

DOI:10.1517/14740338.2013.774371
PMID:23458441
Abstract

INTRODUCTION

Herbal hepatotoxicity represents a poorly understood, neglected and multifaceted disease with numerous confounding variables and missing established causality in the majority of cases. This review discusses overt shortcomings in its clinical and causality assessment and suggests improvements.

AREAS COVERED

A selective literature search of PubMed using the terms herbal hepatotoxicity, herb-induced liver injury, drug hepatotoxicity and drug-induced liver injury was performed to identify published case reports, spontaneous case reports, case series and review articles regarding hepatotoxicity due to herbs, herbal drugs and herbal dietary supplements. Covered areas focused on confounding variables related to the documentation of the herbal product and the clinical course, hepatotoxicity and reexposure criteria, temporal association, comedication and alternative causes with special attention to preexisting diseases of the liver, bile ducts and the pancreas. Of particular interest were recent discussions of approaches designed and validated for hepatotoxicity causality, such as the scale of CIOMS (Council for International Organizations of Medical Sciences).

EXPERT OPINION

The authors call for substantial improvements in data quality of herbal products and case characteristics and strongly recommend using the CIOMS scale to assess causality in suspected herbal hepatotoxicity.

摘要

简介

草药性肝毒性是一种尚未被充分认识、被忽视的多因素疾病,在大多数情况下,其临床和因果关系评估存在诸多混杂因素和尚未确定的因果关系。本综述讨论了其临床和因果关系评估中的明显缺陷,并提出了改进建议。

涵盖领域

使用术语草药性肝毒性、草药肝损伤、药物肝毒性和药物性肝损伤,对 PubMed 进行了选择性文献检索,以确定有关草药、草药药物和草药膳食补充剂引起肝毒性的已发表病例报告、自发性病例报告、病例系列和综述文章。涵盖的领域主要集中在与草药产品和临床病程相关的记录、肝毒性和再暴露标准、时间关联、合并用药和其他原因的混杂因素上,特别关注肝脏、胆管和胰腺的潜在疾病。特别感兴趣的是最近讨论的用于药物肝毒性因果关系评估的方法,如 CIOMS(医学科学理事会国际组织)量表。

专家意见

作者呼吁大幅提高草药产品和病例特征的数据质量,并强烈建议在疑似草药性肝毒性中使用 CIOMS 量表来评估因果关系。

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