Teschke Rolf, Danan Gaby
Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, D-63450 Hanau, Teaching Hospital of the Medical Faculty of the Goethe University, D-60590 Frankfurt/Main, Germany.
Pharmacovigilance Consultancy, F-75020 Paris, France.
Medicines (Basel). 2020 Sep 29;7(10):62. doi: 10.3390/medicines7100062.
A large number of idiosyncratic drug induced liver injury (iDILI) and herb induced liver injury(HILI) cases of variable quality has been published but some are a matter of concern if the cases were not evaluated for causality using a robust causality assessment method (CAM) such as RUCAM (Roussel Uclaf Causality Assessment Method) as diagnostiinjuryc algorithm. The purpose of this analysis was to evaluate the worldwide use of RUCAM in iDILI and HILI cases. The PubMed database (1993-30 June 2020) was searched for articles by using the following key terms: Roussel Uclaf Causality Assessment Method; RUCAM; Idiosyncratic drug induced liver injury; iDILI; Herb induced liver injury; HILI. Considering reports published worldwide since 1993, our analysis showed the use of RUCAM for causality assessment in 95,885 cases of liver injury including 81,856 cases of idiosyncratic DILI and 14,029 cases of HILI. Among the top countries providing RUCAM based DILI cases were, in decreasing order, China, the US, Germany, Korea, and Italy, with China, Korea, Germany, India, and the US as the top countries for HILI. Since 1993 RUCAM is certainly the most widely used method to assess causality in IDILI and HILI. This should encourage practitioner, experts, and regulatory agencies to use it in order to reinforce their diagnosis and to take sound decisions.
大量质量参差不齐的特异质性药物性肝损伤（iDILI）和草药性肝损伤（HILI）病例已被发表，但如果这些病例未使用如RUCAM（罗塞尔 - 优克福因果关系评估方法）这样强大的因果关系评估方法（CAM）作为诊断算法来评估因果关系，那么其中一些病例就令人担忧。本分析的目的是评估RUCAM在全球范围内用于iDILI和HILI病例的情况。通过使用以下关键词在PubMed数据库（1993年 - 2020年6月30日）中搜索文章：罗塞尔 - 优克福因果关系评估方法；RUCAM；特异质性药物性肝损伤；iDILI；草药性肝损伤；HILI。考虑到自1993年以来全球发表的报告，我们的分析显示，RUCAM用于因果关系评估的肝损伤病例有95,885例，其中包括81,856例特异质性药物性肝损伤病例和14,029例草药性肝损伤病例。提供基于RUCAM的药物性肝损伤病例的主要国家按降序排列为中国、美国、德国、韩国和意大利，而提供草药性肝损伤病例的主要国家为中国、韩国、德国、印度和美国。自1993年以来，RUCAM无疑是评估特异质性药物性肝损伤和草药性肝损伤因果关系最广泛使用的方法。这应鼓励从业者、专家和监管机构使用它，以加强诊断并做出合理决策。
