He Wei, Xie Yanming, Wang Yongyan
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2010 Jun;35(11):1498-500.
Re-evaluation of premarketing medicine is a important supplementary of clinical and elementary research. It is a basement that establish the medicine administration supervisition , found and integrity postmarketing washing out mechanism and define reasonable using drug. After drug marketing, we must not only concern on the re-evaluation of herbs security but also focus on evaluating herbs suitable symptom, as well as its dosage and course of treatment, ect. The re-evaluation of symptoms were seen as the core and feature of traditional Chinese medicine's clinical evaluation. It is also seen as hot spot and difficulty of the research . This article try to focus on simply illustrating the necessity and research thinking of re-evaluation symptoms of postmarketing herbs. So we can define the re-evaluation of postmarketing drug's objection, method, and basement. It will provide beneficial experience and reference to re-evaluation symptom of marketed herbs.
上市前药品再评价是临床和基础研究的重要补充。它是建立药品监管、发现和完善上市后淘汰机制以及明确合理用药的基础。药品上市后,既要关注中药安全性再评价,也要注重评价中药的适应证、剂量和疗程等。证候再评价被视为中药临床评价的核心与特色,也是研究的热点和难点。本文试图重点简要阐述上市后中药证候再评价的必要性及研究思路,从而明确上市后药品再评价的目的、方法和依据,为上市中药证候再评价提供有益的经验和借鉴。