Xiao Xiao-He, Zhao Xu, Bai Zhao-Fang, Wang Jia-Bo, Song Hai-Bo
Department of Hepatology,The Fifth Medical Centre of Chinese PLA General Hospital Beijing 100039,China.
School of Traditional Chinese Medicine,Capital Medical University Beijing 100069,China.
Zhongguo Zhong Yao Za Zhi. 2023 May;48(10):2557-2564. doi: 10.19540/j.cnki.cjcmm.20230309.601.
Profound changes have taken place in human disease spectrum, constitution spectrum, and drug use behavior, and the safety of traditional Chinese medicine(TCM) faces new trends and problems. In particular, serious adverse reactions/events such as liver injury and kidney injury caused by non-toxic TCM have been frequently reported, overturning people's understanding of TCM safety, and even shaking the public's confidence in the development of TCM. In the new era of globalization, correctly understanding the situation and problems of TCM safety and addressing the dilemmas in safety evaluation and risk prevention of TCM are the key missions to be undertaken by TCM practitioners. This paper suggests that the situation and problems of TCM safety should be viewed objectively and dialectically, and the use standard of TCM should be advanced with the times. Furthermore, this paper puts forward the new conception and methodology of TCM safety(including one innovative understanding, two types of evaluation modes, tri-elements injury hypothesis; four-quadrant risk decision processes, and five-grade safety evidence body) for the first time, hoping to provide new theories, new strategies, new methods and successful examples for solving the safety problems of TCM.
人类疾病谱、体质谱和用药行为发生了深刻变化，中药安全性面临新的趋势和问题。特别是，无毒中药引起的肝损伤、肾损伤等严重不良反应/事件屡有报道，颠覆了人们对中药安全性的认识，甚至动摇了公众对中药发展的信心。在全球化的新时代，正确认识中药安全性的形势和问题，解决中药安全性评价和风险防控中的困境，是中药从业者肩负的关键使命。本文建议应客观辩证地看待中药安全性的形势和问题，与时俱进推进中药使用标准。此外，本文首次提出了中药安全性的新概念和新方法（包括一种创新性认识、两种评价模式、三元损伤假说、四象限风险决策流程和五级安全证据体），希望为解决中药安全性问题提供新理论、新策略、新方法和成功范例。
