中药上市后证候临床再评价模式探索

Exploration on the Mode of Postmarketing Evaluation of Chinese Medicine on TCM Syndromes

中药上市后证候临床再评价模式是需要慎重思考的顶层设计内容,应明确其分类、适用条件及优缺点等重点内容。证候临床再评价模式大致分为病证结合再评价模式、证候再评价模式及西医病症再评价模式,其中以病证结合再评价模式最为常用,后两者应用范围有限。在中药上市后证候临床再评价中,应根据再评价目的及设计方法等要求,选取适宜的证候临床再评价模式。

The mode of postmarketing evaluation of Chinese medicine on TCM syndromes is the top design content which requires a careful thi nking.In the design,the key contents should be confirmed on the classification,application conditions,and advantages and disadvantages of the mode.The mode of TCM syndromes evaluation include the disease-syndrome in combina tion re-evaluation mode,syndrome re-evaluation mode,and disease re-evaluati on mode,of which,the first one is most commonly used,and the application of the other two is not common.In the postmarketing evaluation,the app ropriate clinical re-evaluation mode of TCM syndromes should be selected on the basis of purpose and design method.