Analysis of adverse reaction reports of drug induced liver injury in Ningde City in past 10 years
Objective To analyze clinical characteristics,occurrence patterns,and possible risk factors of drug-induced liver injury(DILI)in Ningde City over the past 10 years(2013-2023),in order to provide reference for rational and safe drug use in clinical practice.Methods Cases of DILI were screened from the database of the National Adverse Drug Reaction Surveillance System in Ningde between January 1,2013 and December 31,2023,and the report type,gender,age,incubation period,clinical manifestations,distribution of drug classes involved,treatment and outcome were retrospectively analyzed.Results A total of 850 DILI cases were reported,all of which were from medical institutions,of which 326(38.35％)were severely reported and 63(7.41％)were newly reported.The male-to-female ratio was 1.15∶1,and the average age was(55.14±16.56)years,and the patients were mainly 45 years old and above(638 cases,75.06％).DILI involves 260 drugs in 13 categories,mainly including anti-infective drugs,anti-tumor drugs and drugs for cardiovascular system and central nervous system,of which the top three are anti-tuberculosis drugs,lipid-regulating and anti-atherosclerotic drugs and antibiotics.The top five drugs that cause DILI frequency are atorvastatin,isoniazid,rifampicin,rosuvastatin,and pyrazinamide.DILI occurred in most patients on the 2-14 d after treatment(567 cases,66.71％)and 716 patients(84.24％)received prophylactic and/or therapeutic hepatoprotective drugs.A total of 598 patients(70.35％)improved or recovered after treatment.Conclusion When using anti-tuberculosis drugs,statins,antineoplastic drugs and antithyroid drugs in clinical treatment,it is necessary to pay close attention to the biochemical status of patients'liver function,scientifically evaluate the frequency of dynamic monitoring,strengthen the health and rational drug use education of patients,identify suspected DILI in a timely manner,and strengthen the intervention and treatment of moderate to severe DILI.
drug-induced liver injuryanti-tuberculosis drugsstatinsantineoplastic agentspharmacovigilanceadverse drug reaction
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