Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reactions
Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reactions
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DOI：
10.1016/s0168-8278(00)80127-0
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发表时间：
2000-12-01
影响因子：
25.7
通讯作者：
Day, CP
中科院分区：
文献类型：
--
作者：
Aithal, GP;Rawlins, MD;Day, CP
背景/目的：由于缺乏特异性标志物，药物性肝毒性的诊断必须基于间接证据，而且往往不准确。我们评价了临床诊断量表（CDS）在肝毒性药物不良反应（ADR）报告的因果关系评估中的应用。方法：对1992年至1996年向英格兰东北部药品安全委员会报告的135例肝毒性药物不良反应进行了评价。最初，使用“国际共识标准”将反应分类为“药物相关”、“药物无关”和“不确定”，然后使用CDS将每种ADR分类为明确的药物肝毒性（评分>17）、很可能（14-17）、可能（10-13）、不太可能（6-9）或排除药物肝毒性（
Background/Aim: Due to an absence of specific markers, the diagnosis of drug-induced hepatotoxicity is necessarily based on circumstantial evidence and is often inaccurate. We have evaluated the use of the clinical diagnostic scale (CDS) in the causality assessment of hepatotoxic adverse drug reaction (ADR) reports.Methods: 135 hepatic adverse ADRs reported to the Committee on Safety of Medicines in North East England 1992-6 were evaluated. Initially, "International Consensus Criteria" were used to classify reactions as "drug-related", "drug-unrelated" and "indeterminate", Using the CDS, each ADR was then categorised as either definite drug hepatotoxicity (score >17), probable (14-17), possible (10-13), unlikely (6-9), or drug hepatotoxicity excluded (