藥動學-藥效動力學（pharmacokinetic-pharmacodynamic，PK-PD）結(jié)合模型是研究藥物劑量與藥物效應之間定量關(guān)系的有效工具，能較客觀地闡明“時間-血藥濃度-效應”之間三維關(guān)系，對于制劑的研發(fā)、作用機制研究、臨床用藥優(yōu)化及合理應用有重要的參考價值。因此，建立能體現(xiàn)中醫(yī)藥特色的PK-PD結(jié)合模型十分必要。針對PK-PD模型在新藥研發(fā)中的應用趨勢進行展望的同時對其在中醫(yī)藥研究領域的應用現(xiàn)狀進行較系統(tǒng)的闡述，并就中藥效應物質(zhì)基礎的確定、效應指標的選擇等關(guān)鍵問題進行探討并提出建議，以期為今后的相關(guān)研究提供參考。

Abstract: Pharmacokinetics-pharmacodynamics (PK-PD) combined model is an effective tool for studying the quantitative relationship between the drug dose and drug effect, it could clarify the three-dimensional relationship of “time-concentration-effect” more scientifically and provide the reference for the preparation development, mechanism research, clinical treatment optimization, and rational use. It is very necessary to establish the PK-PD combined model that embodies the characteristics of traditional Chinese medicine (TCM). In this paper, the application trends of PK-PD combined model in the development of new drugs are discussed. The application status in the field of TCM research has been systematicly explained and the key problems, such as the investigation of material basis of TCM effects and the selection of effect indicators are studied to make recommendations so as to provide the important reference for future research.

上海市教育委員會重點學科資助項目（J50302）