Objective  To investigate situations of gender, age, smoking, drinking, distribution of traditional Chinese medicine (TCM) syndromes, symptom distribution, TCM diseases, tongue and pulse in patients with acute drug-induced liver injury, analyze the correlation between the characteristics of syndrome elements and diseases.

  Methods  The clinical data of 234 patients with acute drug-induced liver injury who were hospitalized in the Department of Liver Diseases in five tertiary Chinese medicine hospitals in Shaanxi Province and were first diagnosed as acute drug-induced liver injury were retrospectively investigated, and 194 patients were finally included according to various criteria. The related factors of acute drug-induced liver injury and the distribution of TCM syndromes were observed, the distribution and characteristics of TCM syndromes of acute drug-induced liver injury were analyzed, and the standard of syndrome differentiation and treatment was initially established.

  Results  The proportion of hospitalized patients with acute drug-induced liver injury in the liver disease departments of Shaanxi Province of traditional Chinese medical hospitals accounted for 0.9%, and the misdiagnosis rate accounted for 17.1%; of 194 patients with acute drug-induced liver injury, 98 patients (50.5%) had liver injury caused by traditional Chinese medical preparations, 30 cases (15.5%) by anti-tuberculosis drugs, 47 cases (24.2%) by dermatological drugs, and 19 cases (9.8%) by other drugs. Acute drug-induced liver injury was not associated with gender, smoking or drinking, but the incidence rates were higher in 19 to 39 and 40 to 60 age groups. Fatigue of TCM symptoms occurred in 182 cases (93.8%), loss of appetite in 158 cases (81.4%), epigastric fullness in 118 cases (60.8%), nausea in 66 cases (34.0%), vomiting in 30 cases (15.5%), and oil aversion in 34 cases (17.5%), yellow body and eyes in 84 cases (43.3%), yellow urine in 88 cases (45.4%), dry stool in 36 cases (18.6%), loose stool in 8 cases (4.1%), fever in 8 cases (4.1%), pruritus in 32 cases (16.5%). TCM diseases were mainly liver diseases, such as jaundice and hypochondriasis, followed by spleen and stomach diseases, such as distention and fullness, dampness blockage, stomach pain, etc., and lung diseases such as pulmonary atrophy, tuberculosis and cough. The distributions of TCM syndromes were mainly liver stagnation and spleen deficiency syndrome (37.1%), liver and gallbladder damp-heat syndrome (33.0%), damp-heat accumulating spleen syndrome (20.6%), and other syndromes (9.3%). The patients with the disease commonly presented light red tongue with thin white moss, or red tongue with yellow and greasy moss. Pulse conditions were mainly stringy and slippery, stringy or stringy and thin.

  Conclusion  Acute drug-induced liver injury is mainly induced by TCM preparations, dermatological treatment drugs and anti-tuberculosis drugs, and is high in clinical misdiagnosis rate. The TCM manifestations of this disease are jaundice and hypochic pain, common syndromes are liver depression and spleen deficiency, damp-heat of liver and gallbladder, etc. Therefore, correct judgment and TCM syndrome differentiation are helpful to reduce the misdiagnosis rate and improve the clinical efficacy.