临床药物评价的意义和方法

近年来不断有新药及改变剂型或用途的老药投入临床使用.为了达到临床用药符合安全、有效、经济之目的,临床医生重视并学习临床药物评价的意义及方法是很有必要的.本文简要介绍了有关临床药物评价的概念和药物安全性、有效性、药物经济学、药剂学评价的基本方法.儿科临床药物评价的特点主要在于重视药物在小儿不同发育阶段的疗效与不良反应的差异,以及开展用无痛苦或最小痛苦手段对临床药物进行监测.

Meaning and method of clinical drug evaluation

In recent years, more and more new drugs and old drugs which changed their use or forms are put in clinical practice. It is important for doctors to pay attention and study the meaning and the method of clinical drug evaluation (CDE). This paper simply introduce the concept of CDE and the basic method of drug' s safety, effectiveness, economics and medicament. The characteristic of pe-diatric CDE mainly focus on the difference of drug' effectiveness and adverse reaction in developing children, and carry out some methods without pain or with the lowest pain to monitor clinical drugs.