Linden Michael, Strauß Bernhard, Scholten Saskia, Nestoriuc Yvonne, Brakemeier Eva-Lotta, Wasilewski Janice
Forschungsgruppe Psychosomatische Rehabilitation, Charité Universitätsmedizin Berlin.
Institut für Psychosoziale Medizin und Psychotherapie, Universitätsklinikum Jena.
Psychother Psychosom Med Psychol. 2018 Sep;68(9-10):377-382. doi: 10.1055/a-0619-5949. Epub 2018 Oct 4.
There is no generally accepted definition of side effects, which causes problems in research and clinical practice. Not even the distinction between main and side effects is always clear. Several judgments are needed in the assessment of side effects. First, it must be decided where to look for unwanted events. Events are defined by the temporal contingency with the treatment. Second, it must be made a judgement whether it is an unwanted or wanted event. Everything is unwanted, which would be problematic, if it would be possible to do without it. Thirdly, a causal relationship with the treatment must be made plausible. Fourthly, a decision must be made that the treatment has been adequate and not malpractice or other unethical behavior. Side effects can be defined as unwanted consequences of correct treatment. The relevance of side effects is depending on severity and duration.
副作用尚无普遍接受的定义，这在研究和临床实践中引发了问题。甚至主效应和副作用之间的区分也并非总是清晰的。评估副作用需要进行多项判断。首先，必须确定在何处寻找不良事件。事件是由与治疗的时间相关性来定义的。其次，必须判断它是不良事件还是有益事件。如果没有某事物可行，那么一切不可行的事物都是不良的。第三，必须使与治疗的因果关系具有合理性。第四，必须判定治疗是恰当的，而非存在医疗过失或其他不道德行为。副作用可被定义为正确治疗产生的不良后果。副作用的相关性取决于严重程度和持续时间。
