关键词: 药物性肝损伤, 药品不良反应, 临床特征, 回顾性分析

Abstract: Objective To explore the clinical characteristics and related factors of drug-induced liver injuries (DILI).Methods A retrospective analysis was conducted on 116 cases of DILI inpatients in Quanzhou Hospital of Traditional Chinese Medicine from January 2015 to December 2019. The age, gender, underlying diseases, drinking history, suspicious drugs and their causality correlation assessment, clinical symptoms, clinical classification, severity and outcome of these patients were analyzed statistically. Results The ratio of male to female of these DILI cases was 1:1.15, and their ages mainly distributed between 41~70 years-old (59.48%). The common medicine causing DILI were Chinese patent medicine, antibacterials, anti-peptic ulcer agents, antithyroid drugs and antineoplastic agents. Oral administration was the most common route (83.50%). According to the Roussel Uclaf Causality Assessment Method (RUCAM), the causality correlation assessment results of these drugs to liver injuries were mostly probable (59 cases, 50.86%). The main clinical symptoms included fatigue, yellow skin, darker urine, thirst and gastrointestinal symptoms such as decreased appetite and discomfort in abdomen, while 44 cases were asymptomatic. The types of injuries were hepatocellular injury (102 cases, 87.93%), cholestasis type (11 cases, 9.48%) followed by mixed type (3 cases, 2.59%). There were significant differences in the levels of Alanine aminotransferase (ALT), alkaline?phosphatase?(ALP) and γ-glutamyl transpeptidase (GGT) among these three different types of DILI (P<0.05). Grade 1 liver lesion was the most common, with 88 cases (75.86%). The prognosis of DILI was good, and the improvement/cure rate was 93.11%.Conclusion A number of drugs may cause DILI, and Chinese patent medicine was the most common medicine. The clinical symptoms were nonspecific and the clinical types were mainly hepatocellular injury. Most patients had a good prognosis.

Key words: Drug-induced liver injuries, Adverse drug reactions, Clinical characteristics, Retrospective analysis