基于“药性”的中药“毒-效”认知与药物警戒思考

Traditional Chinese Medicine Property-Based Understanding of Toxicity, Efficacy and Pharmacovigilance

目的围绕"药性"探讨中药"毒-效"认知与药物警戒,为中药药物警戒的理论研究与实践提供借鉴。方法以药性理论为基础,结合临床用药实际情况与实验研究,分析和提炼临床有效性与安全性影响因素,探讨论证"性""毒""效"关系,构建以"药性"为核心的中药药物警戒模式。结果 "效""毒"分别是"药性"的正、负向表达,可相互转化。中药药物警戒可从"药性"出发,认识药物特点、促进"毒"转为"效"、防范"效"转为"毒"、解除药物毒性,根据药物自身因素、患者机体因素与临床用药因素,通过源头质量把控、终端信号监测、过程控制预警,实现中药全程警戒。结论 "药性"是中药的临床特色,中药药物警戒应考虑"药性"认知,体现中药"毒-效"应用特点,构建中药特色的药物警戒模式,促使药性理论更好地为临床合理用药服务,为中药药物警戒实践的开展提供新思路。

Objective To explore toxicity, efficacy and pharmacovigilance of traditional Chinese medicine(TCM) based on the property of TCM so as to provide reference for research on and implementation of Chinese medicine pharmacovigilance. Methods Based on related theories, actual clinical medication and experimental research, the factors that influenced the effectiveness and safety of TCM were analyzed, and the relationship between the property, toxicity and efficacy was studied. Meanwhile, a TCM property-based pharmacovigilance model was established. Results Efficacy and toxicity were positive and negative expressions of TCM property, and one could be transformed into the other. Pharmacovigilance of TCM was supposed to start with the property of TCM, which involved advancing our understanding of properties of TCM, facilitating "toxicity to efficacy" transformation, preventing "efficacy to toxicity" transformation and detoxification. Factors including drugs, patients and medication had to be taken into consideration in the whole process of pharmacovigilance by means of quality control, terminal signal monitoring and process warning. Conclusion The medicinal property is the clinical feature of TCM. Pharmacovigilance of TCM calls for keen insights into the property of TCM while giving weight to toxicity and efficacy so as to establish a model of pharmacovigilance that could provide new ideas and guide rational use of TCM.