Abstract: Objective To study ways to discover risk signals of drug-induced liver injury by using the big data platform of the hospital, to screen out the related traditional Chinese medicines that may induce liver injury, and to analyze the risk factors for liver injury. Methods The diagnosis of DILI started with confirmation of liver injury with the data from June 1, 2019 to June 1, 2023, followed by the exclusion of other liver diseases before the causal relationship between drugs and liver injury was quantitatively evaluated using the Roussel-Uclaf causality assessment method (RUCAM). Experienced experts were consulted to exclude inpatients who used chemical drugs (mostly class A and class B drugs) for drug-induced liver injury caused by drug combination before suspicious Chinese medicine varieties were found and sorted out, which were divided into four categories: possible, probable, unlikely and impossible. Results A total of 2 056 patients with abnormal liver function were collected, 142 of whom with possible Chinese medicine-related liver injury were screened out. The types of possible and probable drugs included antidepressants, herbal medicines for removing heat and toxins, activating blood circulation and reducing blood stasis, and for dispelling winddampness. Conclusion There is a wide range of suspected traditional Chinese medicines. The occurrence of drug-induced liver injury may be related to the state of the human body and the drug itself. The mechanism of drug-induced liver injury may be related to immune inflammation.

Key words: HILI, DILI, herb, antidepressants, purgatives to remove heat and toxins, activating blood circulation and removing blood stasis, expelling wind-dampness, clinical features, mechanism