Abstract: Objective To analyze the causes and clinical characteristics of the children with drug-induced liver injury (DILI) in our hospital. Methods A total of 41 patients with DILI under 14 years in our hospital from January 2008 to June 2019 were included, by searching the medical records management system. The diagnosis was established according to DILI standard proposed in 2004. Danan regimen was adopted in the clinical classification of DILI. The measurement data of normal distribution are presented as mean ± standard deviation, the measurement data of non-normal distribution are presented as median (percentage 25, percentage 75), and the count data are presented as percentage. Results Among the patients included, 24 were male (58.5%) and 17 were female (41.5%). The average age was (8.3 ± 3.5) years, ranging from 5 months to 14 years. Among them, 3 were under 1 year (7.3%), 4 were 1 to 3 years old (9.8%), 16 were 4 to 9 years old (39.0%), and 18 were 10 to 14 years old (43.9%). The alanine aminotransferase was 925 (458, 1655) U/L, the aspartate aminotransferase was 525 (175, 1284) U/L, the alkaline phosphatase was 325 (248, 486) U/L, and the total bile acid was 108 (28, 198) mol/L. A total of 14 patients underwent liver biopsy, among whom 9 cases (64.3%) were diagnosed as hepatocellular injury, 2 cases (14.3%) as cholestatic injury and 3 cases (21.4%) as mixed type. The drugs causing DILI included antibacterial drugs (16, 39.0%), Chinese patent medicines or Chinese medicine preparations (13, 31.7%), chemotherapeutic or immunosuppressive drugs (6, 14.6%), anti-tuberculosis drugs (2, 4.9%), antipyretic analgesics and psychotropic drugs (4, 9.8%). Furthermore, antibacterial drugs included macrolides (9, 22.0%), penicillins (4, 9.7%) and cephalosporins (3, 7.3%). And clinical symptoms of these DILI patients included fatigue (23, 56.1%), loss of appetite (31, 75.6%), nausea (16, 39.0%), icteric skin or dark urine (11, 26.8%), vomiting (7, 17.1%), and pruritus or rash (6, 14.6%). Conclusion DILI in children can occur in different ages, and the main drugs leading to the disease are antibiotics, traditional Chinese medicine, chemotherapeutic and immunosuppressive drugs. In the future, these drugs should be appropriately used in children with caution.

Key words: Drug-induced liver injury, Children, Antibacterial agents, Clinical characteristics