Clinical Characteristics And Prognosis Of 314 Patients With Drug-induced Liver Injury

Objective:The clinical characteristics,prognosis and risk factors of 314 patients with drug-induced liver injury(DILI)who were hospitalized in the First Affiliated Hospital of Kunming Medical University from 2014 to 2019 were analyzed retrospectively to provide theoretical basis for clinicians to diagnose,treat and prevent DILI early.Methods:Using the digital medical record retrieval system to retrieve the medical records of DILI diagnosed in the First Affiliated Hospital of Kunming Medical University from January 2014 to December 2019.Rescreening cases based on the inclusion and exclusion criteria,314 cases were included in this study.The patient’s complete medical records were collected,and analyze the clinical characteristics,prognosis and risk factors of DILI.The statistical method was SPSS21.0.The measurement data of normal distribution were expressed by the mean ± standard deviation.The continuous data of nonnormal distribution was expressed by median and interquartile range[M(P25 to P75)].The difference between the two groups was compared by Mann Whitney test.The count data were expressed by the number of cases or the composition ratio.The difference between the two groups was compared by Chi square test or Fisher exact probability method.The risk factors were analyzed by logistic regression.Results:1.In the past six years,the number of hospitalized patients with DILI in the First Affiliated Hospital of Kunming Medical University has increased,mainly in the infectious department(53.50%)and the digestive medical department(42.04%).There were 118 males and 196 females among 314 cases,and the ratio of male to female was 1:1.66.The minimum age was 10 years,the maximum age was 84 years,on average(46.34±14.33)years old,mainly concentrated on 40 to 59 years(57.64%).The average BMI of enrolled patients was(22.55±3.31)kg/m2.The occupational distribution is mainly farmers(39.49%),and the space distribution is mainly Kunming(38.85%).2.Most of the patients were treated with basic diseases(78.66%),and some of them were used for health purposes(12.42%).The most common basic diseases are respiratory system diseases(14.01%),digestive system diseases(12.74%),endocrine diseases(7.96%)and neuropsychiatric diseases(7.64%).3.In our hospital,main medicines causing DILI were traditional Chinese medicine(61.46%),anti-tuberculosis medicines(6.05%),non-steroidal anti-inflammatory drugs(5.73%),antimicrobial drugs(4.78%),and antineoplastic drugs(4.14%).Traditional chinese medicine is mainly used to treat digestive diseases(17.10%),health care(16.06%)and gynecological diseases(9.33%).The time of onset of DILI in majority of patients was within four weeks(66.88%),mainly by oral administration(93.95%).4.The most frequent clinical features of DILI patients in our study were gastrointestinal manifestations(69.75%),jaundice(57.64%)and fatigue(52.87%).A small number of patients only showed abnormal liver biochemical indexes(16.24%).The most common clinical type was hepatocyte injury type,accounted for 88.22%,it is more common in women(177/277 cases),while cholestasis type and mixed type only accounted for 7.00%and 4.78%.5.Severity classification:mild(40.44%),moderate(10.83%),severe(47.77%),Alf(0.64%)and fatal(0.32%).314 DILI patients were divided into two groups(mild group and severe group)according to their severity levels:the mild group includes mild and moderate DILI patients,the severe group includes severe,ALF and fatal DILI patients.Compare the differences in the distribution of gender,age,BMI,allergy history,smoking history,drinking history,diabetes,chronic liver disease,fatty liver(type-B ultrasonic),combined drugs and clinical types between the two groups,it was found that the difference between the groups of fatty liver was statistically significant(p=0.001),that is,patients with fatty liver were more likely to have severe liver injury,while there was no significant difference between the groups of gender,age,BMI,allergy history,smoking history,drinking history,diabetes,chronic liver disease,combined drugs and clinical types(P＞0.05).6.The average hospitalization days of DILI patients were(12.73 ± 5.92)days,and the longest hospitalization time was 40 days.Among the 314 cases,78 cases(24.84%)achieved the standard of cure when they were discharged from the hospital,improved 205 cases(65.29%),30 cases(9.55%)remained unhealed,and 1 case(0.32%)died.To compare the general condition and liver biochemical index level between the group with good prognosis(including cure and improvement)and the group with poor prognosis(including unhealed and death).It was found that the prognosis of patients with chronic liver disease was worse than those without(P=0.019).The prognosis of cholestasis patients is worse than other types of patients(P=0.006).ALB decreased more significantly in the poor prognosis group(P=0.001),TBIL,DBIL,ibil,TBA,ALP,GGT,Pt,INR increased more significantly in the poor prognosis group(P＜0.05),ALT and AST increased more significantly in the good prognosis group than in the poor prognosis group(P＜0.05).Multi variate logistic regression analysis showed chronic liver disease(OR=3.488,P=0.012),ALP(OR=1.007,P=0.000),PT(OR=1.524,P=0.000)may be independent risk factors for prognosis.Conclusions:1.Over the past six years,the number of inpatients with DILI in the First Affiliated Hospital of Kunming Medical University has been increasing.It is more common in 40 to 59 years old,and it is more likely to occur in female patients.2.The vast majority of patients take medication for basic diseases,followed by medication for health purposes.Respiratory diseases,digestive system diseases,endocrine diseases and neuropsychiatric diseases are the most common basic diseases.3.Traditional chinese medicine is the most common cause of DILI,mainly used to treat digestive diseases,gynecological diseases and health care,followed by antituberculosis drugs,non-steroidal anti-inflammatory drugs,antimicrobial drugs and antitumor drugs.DILI mostly occurs within four weeks of taking the drug,mainly oral.4.The clinical features of DILI are non-specific.The main features are gastrointestinal symptoms,jaundice and fatigue.The clinical type is mainly hepatocyte injury type,which is more common in women.5.The degree of severity was mainly in mild and severe,patients with fatty liver are more likely to have severe liver injury.6.The majority of DILI patients had a good prognosis.Most patients with chronic liver disease,ALB significantly reduced,and TBIL,DBIL,IBIL,TBA,ALP,GGT,PT,INR significantly increased have poor prognosis.Chronic liver disease,ALP and PT may be independent risk factors for prognosis.