不良反应概念的合理界定

Rational Definition of the Concept of Adverse Drug Reactions

目的厘清不同研究目的下不良反应概念的合理界定,纠正实践中存在的概念混乱。方法从保证研究目的实现的角度进行分析得出结论。结果与结论因研究目的不同,药理学等实验学科药物不良反应概念与监管规章中药品不良反应概念应有不同的界定,规章中药品不良反应定义存在着不合理,需要修订。

OBJECTIVE： To make sure the rational definition of the concept of adverse drug reactions （ADRs） under different study purposes and to correct the confusion existed in the definitions of ADRs in practical use. METHODS： A conclusion was obtained by analyzing the ways to satisfy the different study purposes. RESULTS ＆ CONCLUSION： Because of the different study purposes, the definition of the concept of ADR in pharmacology and related experimental disciplines should be different from that in supervision regulations.The definition of ADRs in current regulations is somewhat irrational thus it needs to be amended.