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首页> 外文期刊>International Journal of Molecular Sciences >RUCAM in Drug and Herb Induced Liver Injury: The Update
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RUCAM in Drug and Herb Induced Liver Injury: The Update

机译：RUCAM在药物和草药引起的肝损伤中的应用：更新

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RUCAM (Roussel Uclaf Causality Assessment Method) or its previous synonym CIOMS (Council for International Organizations of Medical Sciences) is a well established tool in common use to quantitatively assess causality in cases of suspected drug induced liver injury (DILI) and herb induced liver injury (HILI). Historical background and the original work confirm the use of RUCAM as single term for future cases, dismissing now the term CIOMS for reasons of simplicity and clarity. RUCAM represents a structured, standardized, validated, and hepatotoxicity specific diagnostic approach that attributes scores to individual key items, providing final quantitative gradings of causality for each suspect drug/herb in a case report. Experts from Europe and the United States had previously established in consensus meetings the first criteria of RUCAM to meet the requirements of clinicians and practitioners in care for their patients with suspected DILI and HILI. RUCAM was completed by additional criteria and validated, assisting to establish the timely diagnosis with a high degree of certainty. In many countries and for more than two decades, physicians, regulatory agencies, case report authors, and pharmaceutical companies successfully applied RUCAM for suspected DILI and HILI. Their practical experience, emerging new data on DILI and HILI characteristics, and few ambiguous questions in domains such alcohol use and exclusions of non-drug causes led to the present update of RUCAM. The aim was to reduce interobserver and intraobserver variability, to provide accurately defined, objective core elements, and to simplify the handling of the items. We now present the update of the well accepted original RUCAM scale and recommend its use for clinical, regulatory, publication, and expert purposes to validly establish causality in cases of suspected DILI and HILI, facilitating a straightforward application and an internationally harmonized approach of causality assessment as a common basic tool.
机译：RUCAM（罗素·乌克拉夫因果关系评估方法）或其先前的同义词CIOMS（国际医学组织理事会）是一种公认​​的常用工具，可用于定量评估可疑药物性肝损伤（DILI）和草药性肝损伤的因果关系（HILI）。历史背景和原始工作证实了RUCAM作为将来案例的唯一术语，出于简单和清楚的原因，现在不再使用CIOMS。 RUCAM代表一种结构化，标准化，经过验证且具有肝毒性的诊断方法，该方法将评分归因于各个关键项目，并在病例报告中为每种可疑药物/药草提供了因果关系的最终定量等级。欧美专家先前已在共识会议上确定了RUCAM的第一个标准，以满足临床医生和从业人员对疑似DILI和HILI患者的护理要求。 RUCAM通过其他标准完成并得到验证，从而有助于高度确定性地建立及时诊断。在许多国家和超过二十年的时间里，医生，监管机构，病例报告作者和制药公司成功地将RUCAM用于可疑的DILI和HILI。他们的实践经验，有关DILI和HILI特性的新数据，以及在酒精使用和排除非药物原因等领域中的模棱两可的问题导致了RUCAM的最新更新。目的是减少观察者之间和观察者内部的差异，提供准确定义的客观核心要素，并简化物品的处理。现在，我们介​​绍公认的原始RUCAM量表的更新，并建议将其用于临床，法规，出版物和专家目的，以在怀疑有DILI和HILI的情况下有效地确定因果关系，从而促进直接应用和国际统一的因果关系评估方法作为常见的基本工具。

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