Li Lian-Da, Li Yi-Kui, Li Feng-Jie
Zhongguo Zhong Yao Za Zhi. 2014 Jan;39(1):3-4.
Clinical re-evaluation is to verify the drug's safety and effectiveness again,while the drug itself has not been improved. However, due to the complexity of traditional Chinese medicine, ingredients in bulk drugs, prescription, productive processes, quality standards and other aspects need to be enhanced. So improving the quality, safety and effectiveness of traditional Chinese medicine by clinical re-evaluation is also very necessary. Therefore, except for achieving those basic requirements of medicine, it should also be improved on itself and pay full attention to the particularity, then traditional Chinese medicine's clinical re-evaluation will play its due role.
临床再评价是在药物本身未改进的情况下再次验证药物的安全性和有效性。然而,由于中药的复杂性,其原料药成分、处方、生产工艺、质量标准等方面都需要改进。因此,通过临床再评价来提高中药的质量、安全性和有效性也非常必要。所以,除了达到药品的那些基本要求外,还应自身加以改进并充分重视其特殊性,这样中药的临床再评价才能发挥应有的作用。