近年来中草药引发肾损害的报道日益增多，已影响到相关药物的临床使用。但这些中药具有“肾毒性”（中草药肾病）的报道主要见于动物实验研究（肾损害发生率几乎是100%）及临床个案报道，而在长期中医临床辨证论治使用中，中药肾毒性并非如有些报道的那么高。有鉴于此，本课题拟通过大数据研究阐明上述有“肾毒性”的中药在中医理论指导下，在真实使用环境中这些药物是否有“肾毒性”？若有毒性，其毒性程度如何？肾毒性与性别、年龄、患者肾功能的状态、原发疾病、药物的用量、频次等是否有关？在此基础上根据《内经》“有故无殒”理论，通过动物实验进一步探析中草药引发肾损害的报道多见于动物实验研究，而在中医理论指导下，在真实使用环境中，中药肾损害的发生率远低于文献报道那么高的原因，阐明中药药性（毒性）和“病证”之间的密切关系（“有病则病当之，反之无病则体受之”）。也为“有毒”中药须在中医理论指导下进行安全性评价作出有益的尝试。

In recent years, the reports of nephrotoxicity of Chinese herb Medicine has increased a lot, which has a great impact on its clinical usage. However, the reports of the nephrotoxicity of these herb medicine (Chinese Herbs Nephropathy) are mainly based on the animal experiments and individual clinical cases (almost 100% renal damage). In the long-term use of Chinese herb Medicine guided by. differentiation of TCM, the incidence of renal damage of these Chinese的herbs is not as high as the reported. On this account, our study aims to observe that in the guidance of TCM theory, whether these Chinses herb medicine which are reported to be nephrotoxicial has exactly nephrotoxicity in the real ues of clinical environment. If it is really nephrotoxicial, what degree of its toxicity? Is the toxicity related to gender, age, renal function state, primary disease, dosage and frequency? On this basis, according to the theory of “YOU-GU-WU-YUN” from“Huangdi Neijing”, our study will use the animal experiment to explore the reason why the renal damage caused by Chinese herb medicine is mainly reported in animal experiments and in the real clinical environment, guided by TCM theory, the incidence of renal toxicity caused by Chinese herb medicine is considerably lower than which is reported in literatures. The study also aims to clarify the close relationship between the herbal nature (toxicity) with Disease and Syndrome. It will make a beneficial trial for safety assessment of toxic herbs which should be guided by TCM theory.