南通市2013—2022年上报的药物性肝损伤报告的药物流行病学分析

Pharmaco-epidemiological Analysis of Drug-Induced Liver Injury Reports in Nantong from 2013 to 2022

目的:分析南通市2012—2021年上报的药物性肝损伤(drug-induced liver injury,DILI)报告的药物流行病学特点,为今后临床DILI的应对提供参考。方法:选取2013年1月—2022年12月南通市药品不良反应监测中心系统中的877例与DILI相关的药物不良反应(adverse drug reactions,ADRs)报告作为研究资料,采集所涉药物与DILI的关联性评价,以及药物的种类分布特点。结果:877例ADRs报告中,药物与DILI的关联性主要为“很可能”(517例,占58.95%)和“可能”(349例,占39.79%),其余则为“肯定”(11例,占1.25%);引发DILI的药物主要为抗肿瘤药物(268例,占30.56%)、抗感染药物(194例,占22.12%)、精神疾病用药(176例,占20.07%)和心血管系统用药(133例,占15.17%);抗肿瘤药物中主要的品种为微管蛋白抑制剂(94例)和铂类配合物(46例),抗感染药物中主要的品种为抗结核药物(105例)和抗细菌药物(65例),精神疾病用药中主要的品种为抗精神病药物(169例),心血管系统用药中主要的品种为降血脂药物(121例)。结论:抗肿瘤药物、抗感染药物、精神疾病用药和心血管系统用药是引发DILI的主要药物,临床对这几类药物及其中的主要品种应加强用药监测和宣教,以提升对DILI的应对水平,从而保证患者的用药安全。

Objective:To analyze the pharmaco-epidemiological characteristics of drug-induced liver injury(DILI)reports in Nantong from 2012 to 2021,and provide reference for clinical responses to DILI in the future.Methods:877 adverse drug reaction(ADR)reports concerning DILI from the system of Nantong Adverse Drug Reaction Monitoring Center from January 2013 to December 2022 were selected as research materials.The relevance evaluation on the involved drugs and DILI and the distribution features of drug types were collected.Results:Among 877 ADR reports,the relevance between the drugs and DILI was mainly classified as"very likely"(517 cases,58.95%),"possible"(349 cases,39.79%),and"definite"(11 cases,1.25%).The drugs inducing DILI were primarily antitumor drugs(268 cases,30.56%),anti-infective drugs(194 cases,22.12%),psychotropic drugs(176 cases,20.07%),and cardiovascular drugs(133 cases,15.17%).The main types of antitumor drugs were tubulin inhibitors(94 cases)and platinum complexes(46 cases),the main types of anti-infective drugs were antituberculosis drugs(105 cases)and antibacterial drugs(65 cases),the main type of psychotropic drugs was antipsychotic medications(169 cases),and the main type of cardiovascular drugs was lipid-lowering agents(121 cases).Conclusion:Antitumor drugs,anti-infective drugs,psychotropic drugs and cardiovascular drugs are the primary drugs inducing DILI.Clinical monitoring and education on these drug categories and their key drugs should be strengthened to improve the response to DILI,so as to ensure the medication safety of patients.