Drug-related liver adverse reactions:a report of 326 cases
OBJECTIVE To explore the characteristics of drug-related liver adverse reactions at Peking University People's Hospital over the last decade and provide references for clinical pharmacovigilance and safe drug dosing.METHODS Retrospec-tive analysis was conducted for 326 cases of drug-related liver adverse reactions reported to the national adverse drug reaction moni-toring system from January 1,2013 to December 30,2022.RESULTS There were 161 males(49.39％)and 165 females(50.61％)with an average age of(47.54±23.02)year.There were 265 cases of general ADR(81.29％)and 61 cases of severe ADR(18.71％).According to the New Pharmacology(Edition ⅩⅧ),suspected drugs were classified.Top three drug catego-ries were anti-neoplastic agents(29.48％),cardiovascular system drugs(23.34％)and antibiotics(21.62％).Using R-value as a judgment criterion,57 eligible cases of liver injury were predominantly liver cell injury(n=39),followed by mixed type(n=11)and cholestasis type(n=7).Roussel Uclaf Causality Assessment Method(RUCAM)score was＞8(n=1 18)and 6-8(n=208).Among 326 patients,141 patients fulfilled the criteria of liver injury severity.The grade was Ⅰ(n=99)and Ⅱ(n=42).The aver-age occurring time of liver adverse reactions was(28.76士68.08)day and 82.21％occurred within 1 month after medication.A total of 94.17％of patients took liver protective drugs and 216 of them detailed the use of liver protective drugs.The number of liver protective drugs varied from 1 to 5 with an average use of(1.82±0.87).CONCLUSION Types of drugs causing liver adverse reactions are rather complex and clinical manifestations are generally non-specific.Therefore monitoring high-risk drugs should be strengthened in clinical practices,especially within 1 month after medication.
adverse drug reactionliver adverse reactionsclinical featuresretrospective analysis
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