281例药物性肝损伤不良反应分析  

Analysis of 281 cases of adverse reactions of drug-induced liver injury

作　　者：范玲 顾琴华 吴燕 朱晓静 FAN Ling;GU Qinhua;WU Yan;ZHU Xiaojing(Department of Pharmacy,Suzhou Hospital of Integrated Traditional Chinese and Western Medicine,Suzhou 215101,Jiangsu,China)

机构地区：[1]苏州市中西医结合医院药剂科,江苏苏州215101

出　　处：《中国现代医生》2025年第11期50-53,共4页China Modern Doctor

摘　　要：目的 探讨药物性肝损伤(drug-induced liver injury,DILI)患者的特征、怀疑药物及转归,为临床规范使用药物、减少DILI不良反应提供参考依据。方法 回顾性分析苏州市中西医结合医院2016至2023年期间共计281例DILI不良反应病例资料。对患者年龄、性别、严重程度、临床表现、临床分型、鲁塞尔·乌克拉夫的因果关系评估方法(Roussel Uclaf causality assessment method,RUCAM)评分、损伤程度、联用情况、疾病种类、怀疑药物及转归进行统计分析。结果 在筛选到的281例DILI患者中,一般药品不良反应(adverse drug reaction,ADR)83例,严重ADR 198例。从临床表现来看,主要为皮肤巩膜发黄、纳差、乏力等;从损伤程度来看,轻度肝损伤156例,中度肝损伤121例,重度肝损伤4例;从联用与否来看,联合用药164例,单一用药117例。患者疾病种类排名靠前的是肿瘤、呼吸科疾病、结核感染等。怀疑药物中,排名前3位的药物依次是中药、抗肿瘤类药、抗结核类药,不同怀疑药物类别与是否联用间差异有统计学意义(P<0.05)。最后患者的临床分型与有效性间差异有统计学意义(P<0.05)。结论 中药、抗肿瘤药、抗结核药等相对易引发DILI。患者肝细胞损伤类型、联合用药、疾病种类、基础疾病等均影响DILI的发生。Objective To explore characteristics of patients with drug-induced liver injury(DILI),suspected drugs and outcomes,and to provide reference for clinical standard use of drugs and reduce adverse reactions of DILI.Methods Retrospective analysis of adverse drug reactions of 281 patients with DILI in Suzhou Hospital of Integrated Traditional Chinese and Western Medicine from 2016 to 2023.Age,sex,severity,clinical manifestations,clinical classification,Roussel Uclaf causality assessment method(RUCAM)score,injury degree,combination,disease type,suspected drugs and outcomes of patiengs were statistically analyzed.Results Among 281 patients with DILI,there were 83 general ADRs cases and 198 serious ADRs cases.In terms of clinical manifestations,main manifestations were yellow skin sclera,poor appetite,fatigue and so on.In terms of injury degree,156 cases suffered mild liver injury,121 cases suffered moderate liver injury,and 4 cases suffered severe liver injury.There were 164 cases of combined drug use and 117 cases of single drug use.The top diseases of patients were tumor,respiratory disease,tuberculosis infection and so on.Among the suspected drugs,the top three drugs were Chinese medicine,anti-tumor drugs and anti-tuberculosis drugs in order,and there were significant differences between different types of suspected drugs and whether they were used in combination(P<0.05).There were significant differences in clinical classification and effectiveness(P<0.05).Conclusion Chinese medicine,anti-tumor drugs and anti-tuberculosis drugs are relatively easy to cause DILI.The type of liver cell damage,combination of drugs,types of diseases,and underlying diseases all affect the occurrence of DILI.

关 键 词：药物性肝损伤 中药 抗肿瘤药 抗结核药 

分 类 号：R969.3[医药卫生—药理学]