326例药物相关肝脏不良反应病例分析  

Drug-related liver adverse reactions:a report of 326 cases

作　　者：任晓蕾[1] 詹轶秋[1] 张春燕[1] 黄琳[1] 张晓红[1] REN Xiaolei;ZHAN Yiqiu;ZHANG Chunyan;HUANG Lin;ZHANG Xiaohong(Department of Pharmacy,Peking University People’s Hospital,Beijing 100044,China)

机构地区：[1]北京大学人民医院药学部,北京100044

出　　处：《中国医院药学杂志》2024年第14期1693-1696,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:分析北京大学人民医院近十年药物相关肝脏不良反应的病例特点,为临床药物警戒和安全用药提供参考。方法:对该院2013年1月1日至2022年12月30日上报至国家药品不良反应监测系统中的326例药物相关肝脏不良反应病例进行回顾性分析。结果:326例患者中男性161例(49.39%),女性165例(50.61%),平均年龄(47.54±23.02)岁。一般的药品不良反应265例(81.29%),严重的药品不良反应61例(18.71%)。参照《新编药物学》(第18版)对可疑药物进行分类,位于前3位的药物类别为抗肿瘤药物(29.48%)、心血管系统药物(23.34%)和抗感染药物(21.62%)。以R值作为判断标准,57例检测指标满足分型标准的肝损伤病例以肝细胞损伤型为主(39例),其次为混合型(11例)与胆汁淤积型(7例)。RUCAM评分:>8分为118例;6~8分为208例。326例患者中检测指标满足肝损伤严重程度分级标准的有141例,其中1级99例,2级42例。肝脏不良反应发生时间平均为(28.76±68.08) d,82.21%的患者发生在用药后1个月内。共94.17%患者使用了保肝药物,其中216例详细报告了保肝药的使用情况,保肝药物品种数为1~5种不等,平均使用(1.82±0.87)种。结论:引起肝脏不良反应的药物种类繁杂,临床表现无特异性,临床应加强对高危药物的监测,尤其在用药后1个月内。OBJECTIVE To explore the characteristics of drug-related liver adverse reactions at Peking University People's Hospital over the last decade and provide references for clinical pharmacovigilance and safe drug dosing.METHODS Retrospective analysis was conducted for 326 cases of drug-related liver adverse reactions reported to the national adverse drug reaction monitoring system from January 1,2013 to December 30,2022.RESULTS There were 161 males(49.39%) and 165 females(50.61%) with an average age of(47.54±23.02) year.There were 265 cases of general ADR(81.29%) and 61 cases of severe ADR(18.71%).According to the New Pharmacology(Edition ⅩⅧ),suspected drugs were classified.Top three drug categories were anti-neoplastic agents(29.48%),cardiovascular system drugs(23.34%) and antibiotics(21.62%).Using R-value as a judgment criterion,57 eligible cases of liver injury were predominantly liver cell injury(n=39),followed by mixed type(n=11) and cholestasis type(n=7).Roussel Uclaf Causality Assessment Method(RUCAM) score was >8(n=118) and 6-8(n=208).Among 326 patients,141 patients fulfilled the criteria of liver injury severity.The grade was Ⅰ (n=99) and Ⅱ (n=42).The average occurring time of liver adverse reactions was(28.76±68.08) day and 82.21% occurred within 1 month after medication.A total of 94.17% of patients took liver protective drugs and 216 of them detailed the use of liver protective drugs.The number of liver protective drugs varied from 1 to 5 with an average use of(1.82±0.87).CONCLUSION Types of drugs causing liver adverse reactions are rather complex and clinical manifestations are generally non-specific.Therefore monitoring high-risk drugs should be strengthened in clinical practices,especially within 1 month after medication.

关 键 词：药物不良反应 肝脏不良反应 临床特征 回顾性分析 

分 类 号：R969[医药卫生—药理学]