河南省儿童药品不良反应死亡病例13例分析

Analysis of 13 Cases of ADR/ADE-induced Death in Children from Henan Province

目的:深入分析和评价儿童药品不良反应(ADR)死亡病例报告,以期发现用药风险,为儿童用药提供参考。方法:通过河南省ADR信息监测网络管理平台,筛选出2004-2013年10年间所有儿童ADR死亡病例报告,参考药品说明书、文献报道、国家ADR信息通报等对报告中儿童用药风险进行分析。结果:共收集到13份死亡病例报告,怀疑药品均为注射剂及静脉给药,其中头孢菌素类注射剂ADR报告较多,占37.50%;立即报告的仅为5份,占38.46%,延迟上报时间最长为29 d;均存在不同程度的不合理用药问题,包括抗菌药物滥用、用药错误、超剂量用药、违反禁忌证用药等主要风险因素。结论:临床应通过制订儿童用药诊疗指南、减少多药联用、严格按照说明书规定用药等措施来规范儿童合理用药;并要及时提交完整、准确的ADR报告。

OBJECTIVE：To analyze and evaluate ADR-induced death cases in children in order to find drug use risk and provide reference drug use in children. METHODS：All ADR-induced death cases were selected from Henan ADR Information Monitoring System during 2004-2013,and then the risk of drug use in children was analyzed in terms of drug package inserts,literature report,ADR information bulletin,etc. RESULTS：Of 13 death cases,suspected drugs were all injection via intravenous administration and the large part of them were cephalosperin injection-induced ADR reports,accouating for 37.50%;only 5 cases were reported immediately,accounting for 38.46%. The longest prolonged reporting time was 29 d. Irrational drug use existed at different levels,including antibiotics abuse,medication error,overdose use,violation of contraindication and other risk factors. CONCLUSIONS：Some measures should be taken to standardize rational drug use in children,such as formulating pediatric medication guideline,reducing drug combination,using drugs in accordance with package inserts strictly it is necessary to submit complete and accurate ADR report in time.