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目的:探讨两性霉素B相关肝损伤的发生情况并分析其影响因素。方法:通过医院信息系统收集2013年1月至2017年12月在复旦大学附属中山医院住院期间应用两性霉素B且用药前后肝功能检查结果记录完整患者的病历资料进行回顾性分析。根据《药物性肝损伤诊治指南》进行肝损伤分型与诊断，计算两性霉素B致肝损伤发生率，并将患者按年龄（≤45、>45岁），入院前3个月内有无肝损伤/肝病史，所用两性霉素B剂型（非脂质体、脂质体）、最大日剂量（<30、≥30 mg）、最大日剂量/体重（21 d）、累积剂量（<600、≥600 mg）、累积剂量/体重（45岁者26例；既往有肝损伤/肝病史者15例；应用两性霉素B者30例，应用两性霉素B脂质体者10例，2种剂型均应用者2例；两性霉素B最大日剂量<30 mg、最大日剂量/体重<0.5 mg/kg者25例，≥30 mg、≥0.5 mg/kg者17例；阶梯加量用药者28例，初始剂量即为最大日剂量者14例；累积剂量<600 mg、累积剂量/体重45 years old), with or without history of liver injury/liver disease within 3 months before admission, the dosage form of amphotericin B (non-liposome or liposome), the maximum daily dose (<30 or ≥30 mg), the maximum daily dose/body weight (21 d), the cumulative dose (<600 or ≥600 mg), cumulative dose/body mass (<10 or ≥10 mg/kg), with or without combination use of liver-protective drugs, and with or without combination use of other drugs with hepatotoxicity, the patients were divided into 2 groups, respectively. The levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), alkaline phosphatase (ALP), and gamma-glutamyltransferase (γ-GT) were compared respectively in patients in each 2 groups with above-mentioned 11 different clinical features. The influencing factors of hepatic injury related to amphotericin B were analyzed using multivariate logistic regression analysis and multiple linear regression analysis, whose effect values were expressed as odds ratio (n OR) with 95% confidence interval (n CI) and standardized regression coefficient with 95n %CI and value of n R2.n Results:A total of 42 patients were enrolled, including 31 males and 11 females with ages from 13 to 92 years old and body mass (65.0±12.3)kg. Of the 42 patients, 26 patients were ≥45 years old; 15 patients had history of hepatic injury/liver disease; 30 patients used amphotericin B, 10 used amphotericin B liposome, and 2 used both of them; 25 patients received the maximum daily dose of amphotericin B <30 mg and the maximum daily dose/body mass <0.5 mg/kg, 17 patients had the maximum daily dose ≥30 mg and the maximum daily dose/body mass ≥0.5 mg/kg; 28 patients used amphptericin B with step-up dosage, 14 patients′ initial doses were the maximum daily dose; 24 patients′ cumulative dose of amphotericin B and the cumulative dose/body mass were <600 mg and <10 mg/kg, respectively, while 18 patients′ cumulative dose of amphotericin B and the cumulative dose/body mass were ≥600 mg and 10 mg/kg, respectively; 29 patients received combination use of hepato-protective drugs; 33 patients received combination use of other hepatotoxic drugs. The levels of TBil and ALT in 42 patients after amphotericin B treatment were obviously higher than those before medication ( n P=0.019, n P=0.017). Seven patients were diagnosed as drug-induced liver injury, the incidence of drug-induced liver injury was 16.7%. The result of multivariate logistic regression analysis showed that history of hepatic injury/liver disease within 3 months before admission was the independent risk factor for elevated γ-GT level after medication ( n OR=2.029, 95n %CI: 1.037-3.970, n P=0.039). The results of multiple linear regression analysis showed that the maximum daily dose ≥30 mg and the cumulative dose ≥600 mg were the independent risk factors for elevated TBil level after medication (standardized regression coefficient: 0.59, 95n %CI: 0.28-0.90, n P=0.001; standardized regression coefficient: 1.61, 95n %CI: 0.14-3.07, n P=0.033; n Rn 2=0.524); hepatic injury/liver disease within 3 months before admission was the independent risk factor for elevated ALP and γ-GT levels after medication (standardized regression coefficient: 0.85, 95 n %CI: 0.25-1.45, n P=0.006, n Rn 2=0.205; standardized regression coefficient: 0.89, 95n %CI: 0.29-1.50, n P=0.005, n Rn 2=0.206).n Conclusions:The incidence of liver injury related to amphotericin B in Zhongshan Hospital, Fudan University is 16.7%. The maximum daily dose of amphotericin B ≥30 mg and cumulative dose ≥600 mg are the independent risk factors for the elevated level of TBil, history of hepatic injury/liver disease within 3 months before admission is the independent risk factors for elevated levels of ALP and γ-GT.