| Objective: The purpose of this study is to raise clinicians’ attention to DILI,provide help for the diagnosis of DILI and then put forward some problems which need to be noticed in diagnosis and treatment of DILI by analyzing its incidence and clinical characteristics.Methods:1.The patients who were admitted to the second hospital of Dalian Medical University from 2013.01.01 to 2019.12.31 and diagnosed with DILI were screened.All clinical data of patients that met the inclusion criteria for this study were collected.2.Calculated the annual proportion of DILI to the total hospitalizations(DILI’s total number per year/total number of hospitalizations per year).Analyzed the general clinical characteristics of all patients with DILI,including age and gender characteristics,common clinical symptoms,types and severity of liver injury,the course of DILI,etc.3.The characteristics of intrinsic,idiosyncratic and special type DILI were analyzed respectively.Among them,all patients with idiosyncratic DILI were applied the new version of the RUCAM to determine the causality,and drug categories were classified by the highest RUCAM score.Then the categories and proportions of the drugs that caused idiosyncratic DILI were analyzed.Also the patients were divided into groups according to drug category and liver injury types,and the clinical data between each group were compared.4.The proportion of acute liver failure(ALF)in patients who fulfilled Hy’s law criteria was counted,and the clinical data between the two groups were compared according to whether they fulfilled Hy’s law criteria or not.Results:1.From 2013 to 2019,the proportion of DILI in all inpatients fluctuated between0.45 ‰ and 0.57 ‰,with an average ratio of 0.51‰.This radio gradually increased from 2013 to 2015,reached the highest value of 0.57‰ in 2015.While from 2016 to2018,it fluctuated around 0.52‰,and decreased to 0.47‰ in 2019.2.There were 123 males and 221 females in 344 patients.The ratio of male to female was 1: 1.8.The age range is 18～86 years old,and the average age was55.08±15.28 years old.The number of DILI patients in the 50～69 age group was the largest,accounting for more than 50% of all cases.3.The common clinical symptoms of DILI are jaundice,anorexia,fatigue and nausea.4.A total of 3 patients with intrinsic DILI,6 patients with sinusoidal obstruction syndrome,2 patients with drug-induced autoimmune hepatitis,and 333 patients with idiosyncratic DILI were included.Among the idiosyncratic DILI,271 cases(81.4%)were hepatocellular injury,35 cases(10.5%)were mixed injury,and 27 cases(8.1%)were cholestatic injury.5.164 patients(47.7%)were mild liver injury,59 patients(17.2%)were moderate liver injury,110 patients(32.0%)were severe liver injury,10 patients(2.9%)were ALF,and 1 patient(0.3%)died of DILI.A total of 133 patients met Hy’s law,among which 6cases progressed to ALF,accounting for 4.5%.6.Among the case of idiosyncratic DILI,44 patients scored RUCAM≥9(highly probable),281 patients scored 6 to 8(probable),and 8 patients scored 3 to 5(possible).All RUCAM results were consistent with their liver pathological diagnosis.7.More than half of the drugs which caused DILI were traditional Chinese medicines(TCM).The top five western medicines were NSAIDs,antibiotics,lipid-lowering drugs,anti-rheumatic drugs and anti-tumor drugs.Among the cases of idiosyncratic DILI,the proportion of mixed and cholestatic injury in western medicine group was larger,while the proportion of severe liver injury in TCM group was greater.8.Among the 277 patients with complete data,253 patients(91.3%)were acute injury and 24 patients(8.7%)were chronic injury.However,in the cases of chronic DILI,15 patients’ liver function returned to normal after 1 year,so only 9 patients(3.2%)were really progressed to chronic liver injury.The course of hepatocellular and mixed injury cases were mainly acute,while cholestatic injury accounted for a larger proportion in chronic injury.Conclusion:1.In recent years,the proportion of DILI in all inpatients has not increased continuously but fluctuated within a certain range,and currently showed a downward trend.2.There were more female patients with DILI,and onset age was mainly over 50 years old.3.The common clinical symptoms of DILI are jaundice,anorexia,fatigue and nausea.4.Idiosyncratic DILI was more common than intrinsic and special phenotypes.Hepatocellular injury was the most common type in idiosyncratic DILI.5.The severity of liver injury caused by DILI was mainly mild,while severe liver injury was also very common.A few patients developed into ALF,but very few patients died of DILI.There were many cases met Hy’s law,but only 4.3% of them progressed to ALF.6.RUCAM has great value in diagnosis of DILI.7.Traditional Chinese medicine is the most common drug causing DILI.Among western medicines,NSAIDs,antibiotics,lipid-lowering drugs,anti-rheumatic drugs and anti-tumor drugs are commonly used.Traditional Chinese medicine causes more serious liver damage,while Western medicine causes more mixed and cholestatic DILI.8.Most patients with DILI have a good prognosis,and the course is mainly acute.A few patients may develop into chronic DILI.Compared with hepatocellular and mixed injury,patients with cholestatic DILI progress to chronic injury more likely. |
