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Maclure于1991年提出的病例交叉研究是一种评估短暂效应所致罕见急性事件发生危险的方法。该研究方法的特点为:仅需患者的资料;对照为患者自身;患者的混杂变量(如性别)易控制;可避免对照组选择偏倚。病例交叉研究最适于有如下特征的因果关系的评价:个体暴露不时变化;疾病发生突然、潜伏期短暂;诱导期短暂。病例交叉研究现已用于多种药物不良反应事件的评估,例如:疫苗的安全、药物性皮肤反应、药物暴露与不良后果,以及应用违禁药的风险等。病例交叉研究值得应用于急性不良事件的调查研究。
The case-by-case study proposed by Maclure in 1991 is a method of assessing the risk of a rare acute event caused by a transient effect. The characteristics of this method are: patient data only; control patient self; easy control of patient’s miscellaneous variables (eg gender); avoidance of selection bias in the control group. Case-crossover studies are best suited for the evaluation of causality with the following characteristics: Individual exposure changes from time to time; Sudden onset of disease with short incubation period; Induction period short. Case-crossover studies are now being used to assess a number of adverse drug reactions, such as vaccine safety, medicinal skin reactions, drug exposure and adverse consequences, and the risks of illicit drug use. Case-crossover studies should be used in the investigation of acute adverse events.