中药药物警戒初探

目的:对中药药物警戒理论进行初步探讨,为中药药物警戒工作的开展提供依据。方法:整理药物警戒理论的起源、定义和发展,与我国传统药物警戒理论进行对比,并进一步对中药药物警戒工作的主要内容进行探讨。结果:开展药物警戒工作除应对中药的种植、采集、加工炮制乃至生产、上市后进行监管外,还应对合理的临床应用的全过程进行监管,尤其应加强对有毒中药的监控。结论:重视中药使用过程中的安全性问题才能不断地完善中药药物警戒工作。

Preliminary Study on Traditional Chinese Medicine Pharmacovigilance

OBJECTIVE：To discuss the theory of traditional Chinese medicine （TCM） pharmacovigilance preliminarily, and to provide reference for the development of TCM pharmacovigilance. METHODS：By summarizing the origin, definition and development of pharmacovigilance theory and comparing with the theory of traditional pharmacovigilance in China, TCM pharmacovigilance was discussed preliminarily. RESULTS： The carrying out of TCM Pharmacovigilance should supervise the whole process from cultivation, collection, processing to production, post-marketing study to rational clinical usage of TCM, especially the supervision of toxic herbs. CONCLUSION：The constant perfection of TCM pharmacovigilance need to pay attention to the safety problems in the application of TCM.