Investigate Drug-induced Liver Injury In Clinical Research And Diagnostic Criteria

Objective To investigate the etiology,clinical manifestation and prognosis of drug-induced liver injury(DILI).Furthermore,to investigate the congruity,advantages and disadvantages between CDS and RUCAM scales,and improve on RUCAM scale to perfect the diagnosis of DILI.Methods 33 patients were diagnosed as DILI from2003 to 2008 in the China-Japan Friendship Hospital.Elements included their medicine history,clinical manifestation,results of laboratory tests,and prognosis.Each case was assessed with CDS and RUCAM scales by the same investigator and requirements of each system.Finally,suggestions of improvement were advanced to RUCAM scale.Results1.In the total 33 DILI patients,19 patients were males and 14 patients were females.The incidence male/female ratio was 1.36.Age ranging from 18 to 76 years old,averageage was 49.91 soils 15.45 years old.2.The drugs causing DILI could be classified as follow:Chinese herbal medicine(33.33%),antipyretic analgesics(15.15%),antibiotics(15.15%), immunosuppressive drugs(6.06%) and so on.One of those patients was caused by food supplement.3.No specific clinical manifestation of DILI was found in this study. Major symptoms were anepithymia,nausea and vomit,abdominal pain, jaundice,febricityand hepatomegaly.But four cases were asymptomatic.4.The ALT,ALP,TBIL,DBIL,GGT and AST were elevated obviously.However, 39.39%patients abdominal ultrasonic and CT were normal.5.DILI could be classified as acute hepatocellular injury(63.64%),acute cholestasis(15.15%) and mixtures(6.06%).Nevertheless,five cases couldn't be classified.6.Comparing with two clinical scales,the RUCAM scale showed better discriminative power and produced assessment closer to clinical diagnosis. But the improved RUCAM was closer to clinical diagnosis than the primitive one. 7.51.52%patients were cured,36.36%patients were relieved,while 12.12% patients got worse and left the hospital or died finally.Conclusions1.In the total 33 DILI patients,the incidence male/female ratio was 1.36, and the average age was 49.91 soils 15.45 years old.2.The drugs most commonly causing DILI were Chinese herbal medicine (33.33%),antipyretic analgesics(15.15%) and antibiotics(15.15%).3.No specific clinical manifestation of DILI was found in this study, and asymptomatic cases were not rare.Among those results of laboratory tests,the ALT was most obviously elevated.4.The hepatocellular injury was common in clinic manifestation(63.64%), the cholestasis was relatively less and mixtures were least.5.Comparing with two clinical scales,the RUCAM scale produced assessment closer to clinical diagnosis,but the improved RUCAM was closer than the primitive one.6.Most patients recovered rapidly after stopping the relevant medicine, but a few patients were serious and the prognosis was worse.