116例药物性肝损伤的临床特征及相关因素分析

An analysis of the clinical characteristics and related factors of 116 cases of drug-induced liver injuries

目的探讨药物性肝损伤(DILI)患者的临床特征及相关因素。方法对泉州市中医院2015年至2019年116例DILI病例进行回顾性分析,统计分析DILI患者的年龄、性别、基础疾病、饮酒史,可疑药物及其关联性评价,DILI的临床症状、临床分型、严重程度和转归等临床资料。结果116例DILI患者男女比例1∶1.15,年龄主要集中在41~70岁;引起DILI的主要药物依次是中成药、抗菌药物、抗消化性溃疡药、抗甲状腺药、抗肿瘤药物等,给药途径以口服为主共计172例次(83.50%);RUCAM量表评价结果以很可能为主共计59例(50.86%);临床症状以乏力、身目黄染、尿黄、口干及食欲减退、上腹不适等消化道症状居多,40例患者无症状;DILI中肝细胞损伤型比例最高为102例(87.93%)、胆汁淤积型次之为11例(9.48%)、混合型最少为3例(2.59%),3种分型之间的ALT、ALP、GGT水平比较差异均有统计学意义(F=4.151、109.50、39.27,P<0.05);严重程度分级以1级肝损伤为主共计88例(75.86%);DILI临床转归良好,痊愈及好转率达93.11%。结论多种药物可引起DILI,最主要药物为中成药,DILI临床症状无特异,临床分型以肝细胞损伤型为主,多数患者预后良好。

Objective To explore the clinical characteristics and related factors of drug-induced liver injuries(DILI).Methods A retrospective analysis was conducted on 116 cases of DILI inpatients in Quanzhou Hospital of Traditional Chinese Medicine from January 2015 to December 2019.The age,gender,underlying diseases,drinking history,suspicious drugs and their causality correlation assessment,clinical symptoms,clinical classification,severity and outcome of these patients were analyzed statistically.Results The ratio of male to female of these DILI cases was 1:1.15,and their ages mainly distributed between 41~70 years-old(59.48%).The common medicine causing DILI were Chinese patent medicine,antibacterials,anti-peptic ulcer agents,antithyroid drugs and antineoplastic agents.Oral administration was the most common route(83.50%).According to the Roussel Uclaf Causality Assessment Method(RUCAM),the causality correlation assessment results of these drugs to liver injuries were mostly probable(59 cases,50.86%).The main clinical symptoms included fatigue,yellow skin,darker urine,thirst and gastrointestinal symptoms such as decreased appetite and discomfort in abdomen,while 44 cases were asymptomatic.The types of injuries were hepatocellular injury(102 cases,87.93%),cholestasis type(11 cases,9.48%)followed by mixed type(3 cases,2.59%).There were significant differences in the levels of Alanine aminotransferase(ALT),alkaline?phosphatase?(ALP)andγ-glutamyl transpeptidase(GGT)among these three different types of DILI(P<0.05).Grade 1 liver lesion was the most common,with 88 cases(75.86%).The prognosis of DILI was good,and the improvement/cure rate was 93.11%.Conclusion A number of drugs may cause DILI,and Chinese patent medicine was the most common medicine.The clinical symptoms were nonspecific and the clinical types were mainly hepatocellular injury.Most patients had a good prognosis.