Clinical Features Of 141 Cases Of Severe Drug-induced Liver Injury

Objective:(1)To analyze the causes and clinical characteristics of 141 cases of severe druginduced liver injury.(2)To observe the efficacy and safety of glucocorticoids in the treatment of severe druginduced liver injury.MATERIALS AND METHODS:We collected the data of 141 patients with severe drug-induced liver injury,according to the inclusion and exclusion criteria,who were admitted to the Department of Hepatobiliary and Pancreatic Medicine in our hospital from January 2018 to July 2020,and analyzed the general characteristics(gender,age),pathogenic drugs,the main clinical symptoms,liver function index,classification,treatment and clinical outcome,etc.Patients were divided into steroids use group(n=49)and no steroids use group(n=92).The no steroids use group received routine medical treatment,while the steroids use group were treated with glucocorticoid combined with routine medical treatment.Comparing the general characteristics(gender,age,indubation period,clinical classification,hospital stays),biochemical characteristics(ALT、AST、GGT、ALP、TBIL、DBIL 、TBA、ALB、Hb、PLT、INR、BUN、CR、fasing glucose and so on),adverse reactions(infection,liver failure,elevated blood glucose,elevated white blood cells,hypokalemia and so on)between the two grougs,then screening out different indicators.The clinical efficacy was estimated by percentage of the increase or decrease of biochemistry liver functional indexes to basic values.The period of observation was last for 4 weeks.Efficacy judgment: obvious efficacy indicated AST,ALT,and TBIL were descended to 2ULN within 4 weeks of the observation;efficacy meant these indexes mentioned above were descended to half of the basic values within 4 weeks,but still ≥2ULN.Inefficacy meant the indexes pointed above were not reached the standard or disease aggravation.Result:(1)The top three drugs that cause severe DILI in this study:Chinese herbal medicine/Chinese patent medicine(66.67%),combination drugs(8.51%),and non-steroidal anti-inflammatory drugs(5.67%).(2)The clinical classification of severe DILI in this study: 92 cases of hepatocyte type(65.3%),26 cases(18.4%)of cholestatic type,and 23 cases(16.3%)of mixed type.The average age of the three types of patients with hepatocyte injury type,cholestasis type,and mixed type were(47 ± 12)years,(55 ± 13)years,and(51 ± 13)years,respectively.There are statistical differences between the three types(P=0.023).These results suggested that age may affect the phenotype of DILI.Young people are prone to hepatocyte injury type,while the elderly tend to have cholestasis type.(3)Among 141 cases of severe DILI,there were 46 males and 95 females.The ratio of male to female was 1:2.1.The highest incidence rate was at age between 40 to 60 years(83/141,58.9%).(4)The baseline level of TBi L and the peak level of DBi L in the steroids use group were significantly higher than those in the no steroids use group,and the median hospitalization time and ALT recovery time of the patients were longer than those in the no steroids use group,indicating that patients in the steroids use group were more severe.(5)In the subgroup analysis: the median time for the peak TBi L to 50% reduction was 8days in the steroids use group,which was significantly shorter than that in the no steroids use group(10 days,P<0.01).These results suggested that the administration of glucocorticoid hastened the resolution of liver injury.(6)The adverse reactions of the steroids use group and the no steroids use group were11(22.4%)and 11(12.1%)respectively,and there were no statistical difference between the two groups(P>0.05),which were improved after symptomatic treatment.Conclusion:(1)The higher incidence of severe drug-induced liver injury was at age between 40 to 60 years,and in females the morbidity was much higher than in males.(2)Chinese herbal medicine is a major reason which causes severe drug-induced liver injury,followed by combination drugs and non-steroidal anti-inflammatory drugs.(3)The main clinical type is hepatocellular damage one.Age may affect the phenotype of DILI,patients with hepatocyte injury are younger than those with cholestasis.(4)Empirical and short-term use of glucocorticoid therapy is safe and has certain effect.