药物相互作用早期临床研究在创新降糖药中的应用进展

Application Progress of Early Phase Clinical Drug Interaction Studies in Innovative Hypoglycemic Agents

患者在同时使用多种药物时,常常会发生药物-药物相互作用(DDI),其结果可能导致严重不良反应或改变治疗效果。在糖尿病治疗中,患者合用药物十分普遍,在创新降糖药上市前对其进行DDI临床研究十分必要,而现有的指导原则并未对创新降糖药的DDI临床研究设计和实施做出明确规定。目前该类研究在设计上呈现出多样性和复杂性的特点。现对创新降糖药DDI早期临床研究设计中的一些关键因素:研究类型选择、纳入人群和样本量确定、研究设计方法、给药方案、试验实施及试验结果进行综述,为创新降糖药的DDI早期临床研究提供参考。

Drug-drug interactions(DDI)often occur when patients use multiple medications simultaneously,and the results may lead to severe adverse reactions or altered treatment effects.In the field of diabetes treatment,the combination of medications is very common.It is very necessary to conduct clinical DDI studies on innovative hypoglycemic agents before they are launched.However,the existing guiding principles do not make clear requirements on the design and implementation of clinical DDI studies on such innovative medications.Besides,at present,this kind of studies is characterized by diversity and complexity in design.This article mainly reviews some critical factors in early phase clinical DDI study design:the selection of research type,the determination of the research population and sample size,the study design methods,the dosing schedule,the trial implementation and the interpretation of the study results,to provide a reference for corresponding studies of innovative hypoglycemic agents.