儿童中药新药临床试验用药品的设计选择

The design and choice of clinical experiment drug of children's Chinese new medicine

试验药品是指用于临床试验的试验药、阳性对照药及其模拟剂,由申办单位根据随机和盲法原则生产、包装、提供。任何一项临床试验,首先接触到的就是临床试验药品,其品质的优劣、模拟剂制做的水平、盲法设立的执行,都直接影响着试验的结果与整体试验质量的高低。尤其对于儿童中药新药的临床试验,由于儿童各项生理指标处于变化之中,更增加了中药这一多组分混合物临床试验的复杂性,不良事件较成人高发。因此,了解试验药品应具备的文件、安慰剂制做的方法、设盲的过程与包装标识的要求,不论对临床试验的设计者,还是研究者都不无裨益,对不良反应的判断和试验质量的提高大有好处。

Test drug is referred as experiment drug, positive control and imitation agent, which is manufactued, packaged and supplied by application unit, according to random and blind principle. The first thing contacted in any clinical experiment is test drug, and the good and bad of its quality, the level of imitation agent manufacture and the execution of blind establishment directly influence the result of experiment and global test quality. Especially, regarding the clinical experiment of children new medicine , the diversity of children＇ s physiological indicators raises the complexity of clinical experiment and the incidence of adverse event is higher than that of adult. Therefore, to understand the program file which the experimental drugs should have, the making method of placebo, the process of blind design and the requirements of packaging and labeling is beneficial for clinical test designers and researchers,which is useful in the judge of adverse reaction and the elevation of test quality.