為改善兒童用藥現(xiàn)狀,提高兒童用藥水平,保障兒童健康,國家陸續(xù)推出了一系列鼓勵兒童藥物研發(fā)的利好政策。隨著政策的推行,兒科藥物的臨床研究勢必會越來越多。從事藥物研發(fā)相關(guān)人員應(yīng)該根據(jù)患兒疾病譜、死亡率及死因順位、疾病負擔等臨床需求的迫切程度以及兒童用新藥的研發(fā)需求,選擇優(yōu)先關(guān)注的領(lǐng)域,開發(fā)以臨床價值為導向、與臨床實際需求嚴密結(jié)合的兒童用新藥。著重介紹了近年來兒童疾病的相關(guān)情況以及兒童用藥研發(fā)方向,旨在為兒童藥物臨床研發(fā)立項的前期評估提供一定參考。

In order to improve children's medication information, the government has launched a series of positive policies to encourage clinical research on pediatric drugs. Thus the prophase of the project is of great importance, so as to develop clinical value oriented new drugs that focused on the priority area of concern according to the urgent degree of clinical demands. Researchers have to get familiar with the situation of childhood diseases as well as the clinical demand of pediatric medication. This article introduces the children's mortality rate and disease burden, as well as the changes of disease spectrum in recent years. Its purpose is to give reference to pediatric R&D relevant personnel for the prophase of the project.