在ADR程度判断中,severe reaction是否即指serious reaction?
WHO国际药物监测合作中心对severe一词已作了说明,即severe并非serious的同义词。
Severe通常用于表达强度(intensity),如severe(重度)、moderate(中度)、mild(轻度)。因此,severe reaction一般译为重度或剧烈反应,而serious reaction译为严重反应。 例如,心肌梗死为严重反应,但它可以表现为轻度心肌梗死(mild myocardial infarction)或重度心肌梗死(severe myocardial infarction)。又如头痛可能表现为重度或剧烈头痛(severe headache),但一般不是严重反应。英国黄卡系统对severe reaction所作解释如下:
A severe reaction might be one that is not life-threatening or disabling but in the individual patient it is extreme. An example would be headache which would not normally be considered serious but may be very severe.