临床试验的伦理审查:关注药代动力学差异引起的不良事件

摘要

在新药临床试验中,引起不良事件的因素很多,而受试者存在药代动力学差异就是其中一个重要因素,并已受到广泛关注.药代酶的基因多态性、儿童和老人不同的药代动力学特点,以及合并用药产生的药物相互作用等均可引起不良事件.作为药物临床试验的伦理审查者应熟悉常见不良事件的类型及成因,了解不同人群药代动力学的特征,尽量避免由此引起的不良事件,最大程度的保护受试者的健康和利益.%In clinical trials, there are many factors that cause adverse events, while the pharmacokinetic difference of the subjects is one of the important factors and has received extensive attention. The metabolic enzyme gene polymorphism, different pharmacokinetic characteristics of children and the elderlies, and drug interactions can cause adverse events. The ethics reviewers of drug clinical trials should be familiar with the types and causes of common adverse events, understand the pharmacokinetic characteristics of different populations, and try to avoid adverse events, to protect the health and benefit of the subjects as far as possible.