Ajayi F O, Sun H, Perry J
Office of Clinical Pharmacology & Biopharmaceutics, Food and Drug Administration, Rockville, Maryland 20857, USA.
J Clin Pharmacol. 2000 Oct;40(10):1093-101.
We examined some of the factors that contribute to the development of adverse drug reactions (ADRs) and analyzed postmarketing ADR reports for 22 drugs. The role of metabolic-based drug-drug interaction in the development of ADRs can not be overstated. Assessment of the postmarketing ADR data for 22 drugs revealed that drugs with high potential for eliciting clinically significant ADRs are usually detected and either withdrawn from the market or placed on restricted use within the first year or two of marketing. Postmarketing data could be a useful tool for understanding the ADR profile of drugs if reporting can be adequately monitored and verified. It is hoped that early evaluation of the clinically meaningful factors such as metabolism, pharmacogenetics, and effect of physiologic and pathophysiologic states on the clinical effect of a drug during drug development would significantly reduce the incidence and severity of post-marketing ADRs.
我们研究了一些导致药物不良反应（ADR）发生的因素，并分析了22种药物的上市后ADR报告。基于代谢的药物相互作用在ADR发生过程中的作用再怎么强调也不为过。对22种药物的上市后ADR数据评估显示，具有引发临床显著ADR高潜力的药物通常会在上市后的头一两年内被检测到，要么从市场上撤下，要么被限制使用。如果报告能够得到充分监测和核实，上市后数据可能是了解药物ADR概况的有用工具。希望在药物研发过程中对代谢、药物遗传学以及生理和病理生理状态对药物临床效果的影响等具有临床意义的因素进行早期评估，将显著降低上市后ADR的发生率和严重程度。
