Advances in Roussel Uclaf Causality Assessment Method for diagnosis of drug-induced liver injury and its comparison with structured expert opinion process
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摘要: 药物性肝损伤(DILI)的诊断迄今仍主要依赖排除法,其中最常用的是Roussel Uclaf因果关系评估法(RUCAM)。自1993年发布第一版RUCAM量表以来,2015年又推出了第二版RUCAM量表,对各要素的定义和评分标准进行了适当修订和具体阐述。结构化专家观点评估法(SEOP)是美国DILI网络前瞻性研究所采用的因果关系判断法,因程序过于复杂和耗时耗力,故难以在临床上应用。介绍了RUCAM的研发历史、应用方法,以及2015版RUCAM的改进之处,并简要比较了RUCAM和SEOP诊断DILI的倾向性差异。指出RUCAM和SEOP均存在明显的观察者之间和观察者内部的评估差异,因此有必要探索更为客观、可重复性好、准确且简便的DILI诊断策略。
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关键词:
- 药物性肝损伤 /
- Roussel Uclaf因果关系评估法 /
- 结构化专家观点评估法 /
- 诊断
Abstract: Up to now,the diagnosis of drug- induced liver injury( DILI) still relies on the exclusive method,and the Roussel Uclaf Causality Assessment Method( RUCAM) is the most commonly used scale. Since the release of the first version of RUCAM scale in 1993,the second version was released in 2015,in which the definition and scoring criteria of each key element were revised appropriately and explained in detail. The Structured Expert Opinion Process( SEOP) was designed by the workgroup of DILI network prospective study,but since it is too complicated and time- and energy- consuming,its application in clinical practice is limited. This article introduces the research and development history and application method of RUCAM,as well as the modifications made in the 2015 version of RUCAM,and briefly compares the difference in bias between RUCAM and SEOP in the diagnosis of DILI. It is pointed out that both RUCAM and SEOP have marked interobserver and intraobserver variabilities,and therefore,it is necessary to explore a more objective,reproducible,accurate,and convenient strategy for the diagnosis of DILI. -
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