ObjectiveTo investigate the drugs responsible for drug-induced liver injury (DILI) in children and related risk factors, and to provide a reference for safe drug use in children in clinical practice. MethodsA retrospective analysis was performed for the clinical data of 187 children with DILI, aged 0-14 years, who were treated in The Fifth Medical Center of Chinese PLA General Hospital from January 2008 to December 2017, including medication history, biochemical parameters, symptoms/signs, and clinical outcome. Based on the method of integrated evidence chain, 127 children with medication information were divided into Western medicine-induced DILI group (Western medicine group with 75 children), traditional Chinese medicine (TCM)-induced DILI group (TCM group with 15 children), and the group with DILI induced by Western medicine and TCM (TCM-Western medicine group with 37 children). The reason for medication, medication time, latency of DILI, and drug classification were compared between groups. The Kruskal-Wallis H test was used for comparison of continuous data with skewed distribution between multiple groups, and the Nemenyi test was used for further comparison between two groups; the chi-square test was used for comparison of categorical data between groups. ResultsOf all 187 children with DILI, 116 (62%) had severe liver injury or above, among whom 3 underwent liver transplantation and 1 died, and 45 (24%) developed chronicity. In the Western medicine group and the TCM-Western medicine group, major suspected drugs for DILI were antibiotics, antipyretics, analgesics, and anti-inflammatory drugs, which accounted for 42%, 30%, 56%, and 31%, respectively. In the TCM group, the most common TCM drugs for DILI were those used to treat skin diseases, which accounted for 47% and were mainly the preparations of Fallopia multiflora (33%). There were significant differences between the three groups in medication time (H=11.658, P=0.003) and latency (H=10.945, P=0.004), and the TCM group had significantly longer medication time and latency than the other two groups (all P<0.05). ConclusionMost children with DILI have serious conditions. The risk of liver injury due to medication in children should be taken seriously, and particular emphasis should be placed on the risk of liver injury caused by antibiotics, antipyretics, analgesics, and anti-inflammatory drugs and long-term use of some TCM drugs for skin diseases. [ABSTRACT FROM AUTHOR]