117例新的/严重的儿童药品不良反应分析

Analysis of 117 New/serious Adverse Drug Reactions in Children

目的:分析某院新的/严重的儿童药品不良反应(ADR)的特点,为促进儿童安全用药提供参考。方法:对2017~2018年某院上报的新的/严重的儿童ADR报告进行回顾性分析,内容包括性别、年龄、既往ADR史、家族ADR史,ADR涉及药品品种、剂型及给药途径、是否超说明书用药,ADR累及的系统/器官、发生时间、对原患疾病的影响及转归、关联性评价等。结果:2017~2018年某院上报117例新的/严重的儿童ADR,其中新的ADR 46例(39.32%),严重的ADR 68例(58.12%),新的严重的ADR 3例(2.56%)。关联性评价结果:肯定1例(0.85%),很可能112例(95.73%),可能4例(3.42%)。男性患儿78例(66.67%),女性患儿39例(33.33%);1~3岁患儿所占比例最高。药品剂型以注射剂(52.99%)为主;给药途径以静脉滴注(68.38%)为主。涉及药品品种14类58种,构成比最多的为抗感染药物(47.01%);22例(18.80%)ADR存在超说明书用药。ADR累及系统/器官以皮肤及其附件系统(60.68%)为主,引起严重皮疹23例(19.66%)。用药后0~5 min内(41例)发生ADR比例最高。115例(98.29%)ADR对患儿原患疾病无明显影响,仅2例(1.71%)使患儿病程延长。结论:儿童临床用药需加强监测,国家应尽快出台儿童安全用药的指南及相关法规,药品生产企业需积极完善补充药品说明书中儿童用药信息,临床药学人员应加强对医护及患儿家属安全用药知识的宣教,全面促进儿童安全用药。

Objective:Analyze the characteristics of new/severe child drug adverse reactions(ADR)in a hospital,and provide reference for promoting children’s safe drug use.Methods:A retrospective analysis of the new/serious children’s ADR reports reported by a hospital from 2017 to 2018,including gender,age,past ADR history,family ADR history,ADR involving drug varieties,dosage form and route of administration,off-label uses,system/organ involved in ADR,time of occurrence of ADR,impact on primary disease,outcome,and relevance evaluation.Results:From 2017 to 2018,the hospital reported 117 new/serious ADR in children,of which 46 cases(39.32%)new ADR,68 cases(58.12%)severe ADR,3 cases(2.56%)new serious ADR.Correlation evaluation results:1 case(0.85%)was confirmed,112 cases(95.73%)were likely,and 4 cases(3.42%)were possible.78 cases(66.67%)were male and 39 cases(33.33%)were female;the route of administration was mainly intravenous drip(68.38%).There were 58 kinds of 14 types of drugs involved,and the most common composition was anti-infective drugs(47.01%);Twenty-two patients(18.80%)had ADR in excess of the instructions.The ADR involvement system/organ was mainly based on the skin and its accessory system(60.68%),causing 23 cases of severe rash(19.66%).The ADR ratio was highest in 0 to 5 minutes(41 cases)after administration.115 patients(98.29%)had no significant effect on the primary disease of the child,and only 2 patients(1.71%)prolonged the disease.Conclusion:Children’s clinical medication needs to be monitored.The state should introduce guidelines and relevant regulations for children’s safe medication as soon as possible.Drug manufacturers should actively improve the information on children’s medications in supplementary drug instructions.Clinical pharmacy personnel should strengthen the education of medical care and family members’safe medication knowledge.To promote children’s safety and rational use of drugs.