Jiang Junjie, Xie Yanming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2811-2.
The usage and dosage of Chinese patent medicine are determined by rigorous evaluation which include four clinical trail stages: I, II, III. But the usage and dosage of Chinese patent medicine are lacked re-evaluation after marketing. And this lead to unchanging or fixed of the usage and dosage of Chinese patent medicine instead of different quantity based on different situations in individual patients. The situation of Chinese patent medicine used in clinical application is far away from the idea of the "Treatment based on syndrome differentiation" in traditional Chinese medicine and personalized therapy. Human population pharmacokinetics provides data support to the personalized therapy in clinical application, and achieved the postmarking reevaluating of the usage and dosage of Chinese patent medicine. This paper briefly introduced the present situation, significance and the application of human population pharmacokinetics about re-evaluation of the usage and dosage of Chinese patent medicine after marketing.
中成药的用法用量是通过包括Ⅰ、Ⅱ、Ⅲ期四个临床试验阶段的严格评估来确定的。但中成药上市后缺乏再评价，导致中成药用法用量一成不变或固定化，而非根据个体患者的不同情况进行差异化调整。中成药在临床应用中的情况与中医“辨证论治”和个体化治疗理念相去甚远。群体药代动力学为临床应用中的个体化治疗提供数据支持，并实现了中成药上市后用法用量的再评价。本文简要介绍了群体药代动力学在中成药上市后用法用量再评价方面的现状、意义及应用。
