我国中药药物警戒的历史沿革与发展现状分析

Analysis of the Historical Evolution and Development Status of Pharmacovigilance of Traditional Chinese Medicine in China

目的:对我国中药药物警戒工作进行全面总结,梳理发展中存在的问题并提出解决思路,以期为建立符合中药特点的药物警戒体系、提高中药安全用药水平提供参考。方法:通过梳理中药药物警戒历史发展情况与现状,分析近年来应用在中药药物警戒的新技术,讨论中药药物警戒发展中存在的问题,从中药安全性研究、中药质量评价、临床警戒体系建设等方面提出解决思路。结果与结论:目前我国中药药物警戒在实际工作中还存在缺乏中药上市后安全性研究指导原则、质量评价体系及医疗机构中药药物警戒体系尚不完善等问题,需要监管部门、医疗机构和中药生产企业等各方的共同努力,加快中药安全性研究指导文件出台和医疗机构中药药物警戒体系的完善、加强中药质量评价体系和药物警戒监管科学的研究、落实中药饮片生产企业的责任等,协同推进中药药物警戒体系建设。

Objective:To comprehensively summarize the pharmacovigilance work of traditional Chinese medicine(TCM)in China,sort out the problems existing in the development and propose solutions,and so as to provide references for establishing a pharmacovigilance system in line with the characteristics of traditional Chinese medicine and improving the level of safe use of traditional Chinese medicine.Methods:By combing the historical development and current situation of TCM pharmacovigilance,this paper analyzed the new technologies applied in TCM pharmacovigilance in recent years,discussed the problems existing in the development of TCM pharmacovigilance,and proposed solutions from the aspects of TCM safety research,TCM quality evaluation and clinical vigilance system construction.Results and Conclusion:At present,there are still some problems in the practical work of pharmacovigilance of traditional Chinese medicine in China,such as the lack of guiding principles for post-marketing safety research of traditional Chinese medicine,the quality evaluation system and the imperfect pharmacovigilance system of traditional Chinese medicine in medical institutions.The regulatory authorities,medical institutions and conventional Chinese medicine production enterprises must work together to accelerate the introduction of guidance documents for the safety research of traditional Chinese medicine and the improvement of the pharmacovigilance system of traditional Chinese medicine in medical institutions,strengthen the research on the quality evaluation system of traditional Chinese medicine and the scientific supervision of pharmacovigilance,and implement the responsibilities of traditional Chinese medicine decoction pieces production enterprises,so as to jointly promote the construction of the pharmacovigilance system of traditional Chinese medicine.