毒性中药复方临床安全性再评价的思考

Consideration of clinical safety re-evaluation of toxic traditional Chinese medicine

由于含毒性中药复方制剂的临床不良反应时有报道,所以中药复方的毒性评价备受关注。本文对毒性中药复方临床安全性方面的再评价工作进行了探讨,其中包括如何从中医药的角度认识毒性中药,建立符合毒性中药复方的安全再评价标准,将基因组学、蛋白组学及代谢组学等新技术引入中药安全性再评价中等。针对中药复方在安全性评价中存在的问题进行了讨论,并提出了相应的建议,以期为构建出符合中药特点的安全性再评价方法学体系提供参考。

Clinical adverse reactions of toxic traditional Chinese medicine（ TCM） were occasionally reported,so the toxicity evaluation of TCM has drawn more concerns. In this article,the safety re-evaluation of clinical TCM compounds were discussed,including how to recognize toxic TCM from the perspective of TCM,the establishment of safety re-evaluation criteria in line with toxic TCM compounds,and the application of genomics,proteomics and metabolomics technology in safety re-evaluation of TCM. Problems in safety evaluation of TCM compounds were discussed,and the corresponding recommendations were put forward in order to build safety re-evaluation methodology system in line with the characteristics of TCM.