201例儿童药物性肝损伤不良反应/事件报告分析

201 Cases of Drug-induced Liver Injury in Children

目的探讨儿童药物性肝损伤(DILI)不良反应/事件发生的临床特点和规律,为临床合理用药提供参考。方法采用回顾性研究的方法,从山东省药品不良反应/事件数据库中筛选出201例年龄≤18岁儿童药物性肝损伤病例,进行统计与分析。结果统计数据显示儿童药物性肝损伤中,年龄≥13岁的青少年患者发生率最高,占61.70%。引起DILI的前3大类药物依次为抗感染药、中枢神经系统药、抗肿瘤药;引起儿童DILI频次较高的药物有甲氨蝶呤、利福平、奥氮平等;DILI发生时间以用药后2周内多见(155例,54.20%),其中,给药途径为口服或静脉滴注发生DILI的中位时间有差异。大部分儿童DILI病例在停药及对症治疗后好转。结论临床医务人员应加深对儿童DILI的认识,加强对抗感染药、中枢神经系统药、抗肿瘤药等用药后肝功能的监测,保障患者用药安全。

Objective To investigate the clinical characteristics and patterns of drug-induced liver injury(DILI)in children so as to promote appropriate medication.Methods A total of 201 cases of DILI in children aged 18 or above were collected between January 2013 and December 2017 from the database of Shandong ADR Monitoring Center and analyzed retrospectively.Results Statistical data showed that the incidence of druginduced liver injury in children aged 13 or above was the highest,accounting for 61.70%.The three dominating types of drugs were anti-infective agents,nervous system drugs,and anti-tumor drugs.The top three drugs that were likely to cause DILI were methotrexate,rifampicin and olanzapine.Most of the cases of DILI occurred within 2 weeks of administration(155 cases,54.20%),and the median time of DILI occurrence was different between oral administration and intravenous infusion.Most of these patients recovered after discontinuation of drugs and symptomatic treatment.Conclusion Clinicians should learn more about drug-induced liver injury and strengthen the monitoring of anti-infective agents,nervous system drugs,and anti-tumor drugs to ensure the safety of drug use.