中药临床安全性评价存在的问题与思考

Problems and thoughts in clinical safety evaluation of traditional Chinese medicine

随着中医药事业的现代化和国际化,中药安全性问题也备受关注。目前,无论是国家层面,还是科研团队与医药企业,在中药临床安全性评价的方法学和技术层面都进行了积极探索,开展了大量工作。虽然已经取得可观成绩,但其中仍存在诸多关键问题,如中药不良反应术语不规范、评价指标不清晰、判定方法不合理、评价模式有所欠缺、评价标准需突破、报告制度需完善等。因此,进一步深化中药临床安全性评价研究模式及方法迫在眉睫。基于当前国家要求的药品全生命周期管理,围绕中药临床安全性评价的规范术语、评价模式、判定方法、评价标准、报告制度等5个维度中存在的问题,提出关于构建符合中药特点的全生命周期临床安全性评价方法的初步思考,希望能够为将来开展的研究提供参考。

Amid the modernization and internationalization of traditional Chinese medicine(TCM),the safety of TCM has attracted much attention.At the moment,the government,scientific research teams,and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM.Although considerable achievements have been made,there are still many problems,such as the non-standard terms of adverse reactions of TCM,unclear evaluation indicators,urreasonable judgment methods,lack of evaluation models,out-of-date evaluation standards,and unsound reporting systems.Therefore,it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM.Based on the current national requirements for the life-cycle management of drugs,this study focused on the problems in the five dimensions of clinical safety evaluation of TCM,including normative terms,evaluation modes,judgment methods,evaluation standards,and reporting systems,and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM,hoping to provide a reference for future research.