中文摘要：

药物毒性分为固有毒性（intrinsic toxicity）和特异质毒性（idiosyncratic toxicity）两类,前者在临床前安全性评价阶段通过常规毒理学实验大多可以被发现,而后者往往在临床评价阶段才被发现,是当前药物上市后出现严重不良反应以及导致药物退市的主要原因。评价和预测药物特异质毒性是极具挑战的国际性难题,也是转化毒理学和精准医学发展的必然要求。中药（复方）已有数千年的人体应用历史和安全性经验,除小部分毒剧类中药为固有毒性外,大部分传统无毒中药的临床不良反应或与特异质毒性有关,即其发生与临床疾病、证候、机体状态、体质等个体因素不无关系。然而,这些病、证相关因素在常规毒理学实验中往往难以涉及和评价,造成中药安全性实验评价结果难以指导临床精准用药的困境。为此,本文跳出当前化学药临床前安全性评价模式的传统思维,在系统对比分析中药和化学药在毒性特点、用药规律、评价需求等方面异同的基础上,提出中药病证毒理学（disease-syndrome-based toxicology）理念,构建关联临床病证的中药安全性评价新策略和方法,以期科学认知和精准评价中药毒性的相对性、易感性及可控性,践行和发展中医药辨证用药减毒理论,促进中医药精准医学发展。

英文摘要：

Drug toxicity is commonly divided into intrinsic and idiosyncratic types. The former can be generally uncovered in the preclinical safety evaluation stage by conventional toxicological experiments, while the latter is usually found only in the clinical evaluation stage, which is the main cause of severe adverse reactions and withdrawal of post-marketing drugs. Assessment and prediction of idiosyncratic toxicity is a challenging problem worldwide, and is an essential in the development of translational toxicology and precision medicine. Since traditional Chinese medicines （TCMs） have been applied for thousands of years with long experience in clinical efficacy and safety, idiosyncratic toxicity is regarded as an important factor for traditional ＂non-toxic＂ medicines and is associated with multiple individual states including different diseases, syndromes, habitus, etc. However, these individual conditions related to disease are often difficult to be resolved in conventional toxicological experiments, leading to insufficient translation of the experimental results into clinical application. We took an approach of systematic analysis of the differences and similarities in toxic property, medication rule and evaluating requirement between TCMs and chemical synthetic medicines. We present a novel and clinic-associated safety assessment strategy, namely as ＂disease-syndrome-based toxicology＂, for TCMs. The strategy is able to access the relativity, susceptibility and controllability of the toxicity of TCMs. The new strategy provides a theoretical and methodological guidance to practice and development of the TCM in favor of t~recision medicine.