摘要
目的:了解药物性肝损伤在自发报告中分布情况及相关药品,为临床提供风险点参考。方法:基于2016-2018年解放军ADR数据库中70 709例自发报告数据,回顾性分析目标患者的性别、年龄、致病药物及预后情况。结果:2838例肝胆损害报告中,筛选出RUCAM量表≥6分的药物性肝损伤279例(9.83%),男172例(61.65%),女107例(38.35%)。排名前5位的药物类别是抗感染药物(39.78%)、心血管系统用药(16.85%)、抗肿瘤药物(15.05%)、代谢及内分泌系统用药(5.73%)、中药(5.73%);排名前5的品种是阿托伐他汀、莫西沙星、利福平、左氧氟沙星、头孢哌酮舒巴坦。平均潜伏期27.52 d,以40~59岁患者的平均潜伏期最长(51.10 d)。结论:严重的药物性肝损伤占比相对低,呈潜伏期长、男性多于女性、涉及药物分布广等特点;提示长期使用具潜在肝毒性药物时应监测肝功能;信息详实的ADR报告数据可以满足RUCAM量表的评价标准。
OBJECTIVE To study the distribution of drug-induced liver injury in spontaneously report and related drugs,so as to provide clinical risk point of reference.METHODS Based on the PLA ADR database from 2016 to 2018,70709 cases of spontaneous reporting data,target were retrospectively analyzed the gender,age,disease,drug and prognosis of patients.RESULTS Among 2838 cases of hepatobiliary injury,279 cases(9.83%)of drug-induced liver injury with RUCAM scale≥6 were screened,172 cases(61.65%)were males and 107 cases(38.35%)were females.The top five drug categories were anti-infective drugs(39.78%),cardiovascular system drugs(16.85%),anti-tumor drugs(15.05%),metabolic and endocrine system drugs(5.73%),and traditional Chinese medicines(5.73%);the top five varieties were atorvastatin,moxifloxacin,rifampicin,levofloxacin,and cefoperazone sulbactam.The mean latency was 27.52 days,with the longest mean latency in patients aged 40 to 59 years(51.10 days).CONCLUSION Severe drug-induced liver injury accounts for a relatively low proportion,characterized by long latency period,more males than females,and wide distribution of drugs involved;it suggests that long-term use of potentially hepatotoxic drugs to monitor liver function;well-informed ADR report data can meet the evaluation criteria of RUCAM scale.
作者
孔祥豪
杨鸿溢
郭代红
范琦
刘思源
于承暄
朱雨
KONG Xiang-hao;YANG Hong-yi;GUO Dai-hong;FAN Qi;LIU Si-yuan;YU Cheng-xuan;ZHU Yu(College of Pharmacy,Chongqing Medical University,Chongqing 4016,China;Department of Pharmacy,Medical Security Center,Chinese People's Liberation Army General Hospital,Beijing 100853,China)
出处
《中国医院药学杂志》
CAS
北大核心
2020年第16期1744-1748,共5页
Chinese Journal of Hospital Pharmacy
基金
国家自然科学基金面上项目(编号:81773825)
2017年军事医学创新工程重点项目(编号:17CXZ010)。
关键词
药物性肝损伤
自发报告
不良反应
药物警戒
肝胆损害
drug-induced liver injury
spontaneous reported
adverse reactions
pharmacovigilance
hepatobiliary impairment
