| Objective: The purpose of this study was to explore the agents implicated in drug-induced liver injury(DILI), evaluate the clinical manifestation, risk factors and prognosis of different types of DILI.Methods: We included patients in the First Hospital of Lanzhou University between January 2011 and September 2015, based on the causality relationship between the suspected drugs and the liver function abnormality and exclusion of other causes. We collected the clinical, serologic, treatment and prognosis information of those diagnosed with DILI. Statistical methods were used to explore the agents implicated in drug-induced liver injury(DILI), study the clinical manifestation, risk factors and prognosis of different types of DILI.Results: 1. Finally 103 patients had been enrolled in our research. 96.2% patients had been classified as probable or highly probable based on the RUCAM. 51.5% of the participants were male and 48.5% were women. The mean age of 103 DILI patients was 47.2±15.2 years old, 71.8% of the participants were older than 40 years old. 7.7% of cases had a history of drug allergy. 8.7% of cases had a history of diabetes mellitus. The average BMI of enrolled patients was 22.2±3.5kg/m2.2. In all enrolled patients, there were 61(59.2%) cases of the hepatocellular pattern, 23(22.3%) cases of the mixed pattern and 19(18.5%) of the cholestasis pattern. The mean age of different patterns of liver injury were 45.4±14.2, 45.3±18.0, 52.8±13.8, respectively, in hepatocellular, mixed and cholestasis pattern, which had statistically significance(p<0.05). The mean age was the highest in cholestasis pattern compared with hepatocellular(p=0.011) and mixed(p=0.028). The level of alanine aminotransferase and aspartate aminotransferase elevated highly in hepatocellular pattern compared with mixed(p=0.000) and cholestasis(p=0.000), the level of alkaline phosphatase elevated highly in mixed and cholestasis pattern compared with hepatocellular(p=0.000).3. The most frequent complains of DILI patients in our study were jaundice(62.1%), weakness(51.4%), nausea(36.0%), anorexia(24.3%), skin itching(13.6%) and fever(13.6%).4. In all enrolled patients with DILI, traditional Chinese medicine was implicated in 50 cases(48.5%), while 53 cases(51.5%) were caused by Western medicine. Multi Herbs combined was the most common, Herbs used in therapy for digestive system diseases and skin diseases were also common. Polygonum multiflorum was the major implicated Herbs with single component(3.9%). Antimicrobial and antipyretic analgesics were the major implicated Western medicine. The level of alkaline phosphatase elevated higher in Herbs-induced liver injury than Western medicine(p=0.049). Based on Roussel Uclaf Causality Assessment Method, 86.0% of cases caused by Herbs were classified as probable and only 12.0% as highly probable, significantly different from Western medicine(43.4% and 50.9%, all p =0.000).5. In all enrolled patients in this study, the severity of liver injury were mild DILI in 17.5%, moderate DILI in 14.5%, severe DILI in 43.7%, ALF in 23.3%, and death in 1.0%. The mean age was older in severe DILI than mild DILI(p=0.000) and moderate DILI(p=0.030), the mean age was higher in ALF than mild DILI(p=0.027).6. In total, 86 cases(83.5%) obtained a good prognosis after the withdrawal of the implicated agents and medical treatment for liver injury, 16(15.5%) cases developed into chronic DILI, and 1(1.0%) cases death due to liver injury. The cholestasis pattern in the chronic DILI was more than those obtained a good prognosis(p=0.034). The level of total bilirubin and direct bilirubin in serum elevated higher in the chronic DILI than those obtained a good prognosis(p=0.001, p=0.000).Conclusions: 1. DILI is a frequent cause of acute liver failure. Multi Herbs combined was the most common, Herbs used in therapy for digestive system disease and skin disease were also common. Antimicrobial and antipyretic analgesics were the major implicated Western medicine.2. Based on the RUCAM assessment, the causal relationship between Western medicine and liver injury is more accurate than Herbs. When Herbal hepatotoxicity had a low RUCAM score, DILI may still need to be alert.3. In our study, age may be the risk factor of the severity of DILI. The incidence of chronic of DILI is about 15.5%, the cholestasis pattern may predispose to chronic DILI, the level of total bilirubin and direct bilirubin in serum elevated in the early may be the risk factor of chronicity. |
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