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草药性肝毒性:因果关系评估方法的挑战和误区。

Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods.

机构信息

Division of Gastroenterology and Hepatology, Department of Internal Medicine II, Klinikum Hanau, D-63450 Hanau, Germany.

出版信息

World J Gastroenterol. 2013 May 21;19(19):2864-82. doi: 10.3748/wjg.v19.i19.2864.

Abstract

The diagnosis of herbal hepatotoxicity or herb induced liver injury (HILI) represents a particular clinical and regulatory challenge with major pitfalls for the causality evaluation. At the day HILI is suspected in a patient, physicians should start assessing the quality of the used herbal product, optimizing the clinical data for completeness, and applying the Council for International Organizations of Medical Sciences (CIOMS) scale for initial causality assessment. This scale is structured, quantitative, liver specific, and validated for hepatotoxicity cases. Its items provide individual scores, which together yield causality levels of highly probable, probable, possible, unlikely, and excluded. After completion by additional information including raw data, this scale with all items should be reported to regulatory agencies and manufacturers for further evaluation. The CIOMS scale is preferred as tool for assessing causality in hepatotoxicity cases, compared to numerous other causality assessment methods, which are inferior on various grounds. Among these disputed methods are the Maria and Victorino scale, an insufficiently qualified, shortened version of the CIOMS scale, as well as various liver unspecific methods such as the ad hoc causality approach, the Naranjo scale, the World Health Organization (WHO) method, and the Karch and Lasagna method. An expert panel is required for the Drug Induced Liver Injury Network method, the WHO method, and other approaches based on expert opinion, which provide retrospective analyses with a long delay and thereby prevent a timely assessment of the illness in question by the physician. In conclusion, HILI causality assessment is challenging and is best achieved by the liver specific CIOMS scale, avoiding pitfalls commonly observed with other approaches.

摘要

草药性肝毒性或草药相关肝损伤(HILI)的诊断是一个具有挑战性的临床和监管问题,对于因果关系评估存在重大陷阱。一旦怀疑患者存在 HILI,医生就应开始评估所用草药产品的质量,优化临床数据的完整性,并应用国际医学组织理事会(CIOMS)量表进行初步因果关系评估。该量表具有结构性、定量性、肝脏特异性,并经过肝毒性病例验证。其各项提供个体评分,这些评分共同产生高度可能、可能、可能、不太可能和排除的因果关系级别。在完成包括原始数据在内的其他信息后,应将包含所有项目的 CIOMS 量表报告给监管机构和制造商,以进行进一步评估。与其他许多因果关系评估方法相比,CIOMS 量表是评估肝毒性病例因果关系的首选工具,因为其他方法在各种方面都存在不足。其中有争议的方法包括 Maria 和 Victorino 量表,这是 CIOMS 量表的一个不充分合格、缩短版本,以及各种非肝脏特异性方法,如临时因果关系方法、Naranjo 量表、世界卫生组织(WHO)方法和 Karch 和 Lasagna 方法。药物性肝损伤网络方法、WHO 方法和其他基于专家意见的方法需要专家小组,这些方法提供回顾性分析,延迟时间长,从而阻止医生及时评估所关注的疾病。总之,HILI 因果关系评估具有挑战性,最好通过肝脏特异性的 CIOMS 量表来实现,避免其他方法常见的陷阱。

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