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目的:分析药品不良反应(ADR)信号检测中不相称性测定理论在实际应用中所存在的问题,阐明不相称性测定理论的使用条件,分析引起问题的原因。方法:通过数学计算、计算公式推导,配合实例进行分析和阐述。结果:不相称性测定理论在ADR信号检测中存在着测量值失衡、联合用药分析能力弱、产生假阳性和假阴性信号等问题,产生问题的根源在于自发呈报系统的数据特征,往往不符合不相称性测定理论的假设及相对数引起的分析偏差。结论:使用不相称性测定理论进行不良反应信号分析,需要明确方法的使用条件以及不良反应检测数据的特征;同时积极开发基于绝对数的新的信号检测方法,弥补不相称性测定理论的不足
OBJECTIVE: To analyze the problems existing in the practical application of the theory of asymmetry in the detection of adverse drug reactions (ADR) signals, to clarify the conditions for using the theory of asymmetry determination and to analyze the causes of the problems. Methods: Through mathematical calculation, calculation formula deduction, with examples to analyze and elaborate. Results: The theory of disproportionality has some problems in ADR signal measurement, such as imbalance of measurement, weak combination analysis ability, false positive and false negative signals. The origin of the problem lies in the data characteristics of spontaneous reporting system, Assumptions of the theory of proportionality determination and analytical deviations caused by relative numbers. CONCLUSIONS: The analysis of adverse reaction signals using the asymmetry assay theory requires a clear method of use conditions and the characteristics of the adverse reaction detection data; meanwhile, a new signal detection method based on absolute numbers is actively developed to make up for the shortage of the theory of asymmetry determination