摘要
现代中成药的用法用量是经过严格的Ⅰ,Ⅱ,Ⅲ期临床试验确定的,上市后亦缺少关于用法用量再评价的深入研究。因此,临床应用中成药时,其用法用量基本固定,并没有依据个体情况调整给药剂量,这种用药方法不符合个体化治疗的理念。人体群体药代动力学可为临床个体化用药提供数据支持,从而实现中药上市后用法用量再评价。该文简要介绍中药上市后用法用量再评价的现状、意义,以及人体群体药代动力学在中药上市后用法用量再评价中的应用。
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 indi- vidual 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.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2011年第20期2811-2812,共2页
China Journal of Chinese Materia Medica
基金
国家"重大新药创制"科技重大专项(2009ZX09502-030)
中国中医科学院自主选题研究项目(Z0133)
关键词
人体群体药代动力学
中药上市后再评价
用法用量
human population pharmacokinetics
reassessment of Chinese medicine in the post-marketed
usage and dosage
