West Midlands Centre for Adverse Drug Reactions, City Hospital, Birmingham, UK.
Drug Saf. 2010 Jan 1;33(1):15-23. doi: 10.2165/11318910-000000000-00000.
The mechanisms of adverse drug effects have not been adequately classified. Here, we propose a comprehensive mechanistic classification of adverse drug effects that considers five elements: the Extrinsic chemical species (E) that initiates the effect; the Intrinsic chemical species (I) that it affects; the Distribution (D) of these species in the body; the (physiological or pathological) Outcome (O); and the Sequela (S), which is the adverse effect. This classification, which we have called EIDOS, describes the mechanism by which an adverse effect occurs; it complements the DoTS classification of adverse effects (based on clinical pharmacology), which takes into account Dose responsiveness, Time course, and Susceptibility factors. Together, these two classification systems, mechanistic and clinical, comprehensively delineate all the important aspects of adverse drug reactions; they should contribute to areas such as drug development and regulation, pharmacovigilance, monitoring therapy, and the prevention, diagnosis, and treatment of adverse drug effects.
药物不良反应的机制尚未得到充分分类。在这里，我们提出了一种全面的药物不良反应机制分类，考虑了五个要素：引发效应的外源性化学物质 (E)；它所影响的内源性化学物质 (I)；这些物质在体内的分布 (D)；（生理或病理）结果 (O)；以及后遗症 (S)，即不良反应。这种分类方法，我们称之为 EIDOS，描述了不良反应发生的机制；它补充了基于临床药理学的 DoTS 不良反应分类（基于剂量反应、时间过程和易感性因素）。这两种分类系统，即机制和临床分类，全面描述了药物不良反应的所有重要方面；它们应该有助于药物开发和监管、药物警戒、治疗监测以及预防、诊断和治疗药物不良反应等领域。
