The Collaborative Group of Hepatobiliary Diseases of the Chinese Medical Association Division of Gastroenterology formulated the diagnosis and exclusion criteria of drug-related liver injury. 1.Diagnostic criteria: ①There is a regularity with the time of drug treatment and the appearance of symptoms: the incubation period of liver injury after the first use of drugs is within 5~90d (suggestive), the incubation period of those with idiosyncratic reaction can be less than 5d, and the incubation period of liver injury caused by slow metabolizing drugs (e.g., iododine) can be more than 90d (doubtful). The latency period for hepatocellular injury after drug discontinuation is ≤15d, and the latency period for cholestatic liver injury is ≤30d (suspicious). ② There is a course of rapid improvement of liver biochemical indexes after stopping the drug: serum ALT level decreases >50% within 8d (highly suggestive) or ≥50% within 30d (suggestive) for hepatocellular injury type; serum ALP or TB decreases ≥50% within 180d (suggestive) for cholestatic type. ③ Liver injury due to other etiologies or diseases must be excluded. ④ Positive response to re-administration: after re-administration of the drug, liver injury is rapidly stimulated, and the elevation of liver enzyme activity level is at least greater than the upper limit of the normal range by a factor of 2 or more. If ①+②+③ of the above diagnostic criteria are met, or 2 out of the first 3 items are met, together with item ④, it can be diagnosed as drug-induced liver injury. Liu Xiaofeng, Department of Gastroenterology, Jinan General Hospital, Jinan Military Region 2, exclusion criteria: ① does not meet the regularity of drug treatment and the time of symptoms. That is, liver injury has occurred before taking the drug, or liver injury occurred after stopping the drug >15d, the occurrence of cholestatic or mixed liver injury >30d (in addition to slow metabolizing drugs). (ii) Abnormally elevated liver biochemistry does not recover rapidly after drug discontinuation. In the hepatocellular injury type, serum ALT level decreased <50% within 30d; in the cholestatic type. Serum ALP or TB levels decreased <50% within 180d. (iii) There is clinical evidence of other etiologies or diseases leading to liver injury. If there is ③ and any 1 of ① ②, it is considered that there is no correlation between drugs and liver injury, and drug liver injury can be clinically excluded. Suspected cases: mainly include the following two conditions: ① there is a reasonable time relationship between medication and liver injury, but at the same time there are other causes of liver injury or disease state; ② the evaluation of the time relationship between medication and liver injury did not reach the level of relevance evaluation of the prompt, but there is no clinical evidence of other causes of liver injury or disease.