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单病例药物不良事件的因果关系评估或诊断,不仅涉及临床的治疗决策,而且也是药物不良反应研究的方法学内容.《Adverse Drug Reaction.A Practical Guide to Diagnosis and Management》介绍了一种新方法—RUCAM(Roussed Uclaf Causality Assessment Method),现编译如下:评价项目、计分标准及药源性急性肝损害评估的具体标准见附表.从理论上讲,根据表1,累计总分的范围为-9~15分,但实践中几百例各种药物不良事件评估结果表明,总分波动在-5~13分之间.累计总分的含义与通用的分级含义比较,用于急性肝损害时,其对应关系为:≤0分,不可能(excluded);1~2分,可疑(unlikely);3~5分,可能(possible);6~8分,很可能(probable);>8分,极可能(Righly).
The causal evaluation or diagnosis of single-case adverse drug events not only involves clinical treatment decisions but also the methodological content of adverse drug reactions studies. “Adverse Drug Reaction. A Practical Guide to Diagnosis and Management” describes a new approach - The RUCC (Roussed Uclaf Causality Assessment Method) is compiled as follows: The specific criteria for evaluation items, scoring criteria and drug-induced acute liver damage assessment are listed in the attached table. Theoretically, according to Table 1, the cumulative total score range is - 9 to 15 points, but in practice, hundreds of cases of adverse events in a variety of drug evaluation results show that the total score fluctuations in the -5 to 13. The meaning of the cumulative score with the general classification meaning, for acute liver injury , The corresponding relationship is: ≤ 0 points, excluded; 1 to 2 points, unlikely; 3 to 5 points, possible; 6 to 8 points, probable;> 8 points Most likely (Righly).