338例儿童药品不良反应回顾性分析

Retrospective analysis of 338 cases of adverse drug reaction reports in children

目的:分析笔者所在儿童医院药品不良反应(ADR)的发生特点和规律,为减少患儿ADR发生,促进临床安全合理用药提供参考依据。方法:采用回顾性分析法,对笔者所在医院2013-2014年上报的338例ADR病例进行统计分析。结果:338例ADR病例中,新的和严重的病例占28.40%;给药方式以静脉滴注最多达75.70%;引发ADR最多的为抗菌药物达58.88%;ADR病例数量最多的为注射用头孢呋辛钠达11.54%;338例ADR几乎累及了全身系统,其中皮肤及其附件最多达76.33%;严重ADR在联合用药中的比例(22.00%)高于无联合用药中比例(10.07%);按照类型分,最多的为B型高达82.25%;时间关联性以B型最明确,发现时间在给药后2 h内高达87.77%;A型ADR新的和严重的报表所占比例最高达41.82%。结论:本次调研发现静脉给药30 min内ADR发生率较其他给药途径高;严重的ADR更倾向于在给药后数分钟内发生;联合用药可能是严重ADR发生的一个重要危险因素;B型ADR所占比例最高可能与其时间关联性强有关。

OBJECTIVE To reduce incidence of ADR and promote safe and rational drug usage by analyzing characteristics and regularity of adverse drug reactions（ADR）in our hospital.METHODS A total of 338 ADR reports were collected from our hospital from2013 to 2014,and were retrospectively analyzed.RESULTS Of 338 ADR cases,new and serious ADR cases accounted for 28.40%.The most common route of administration for ADRs was intravenous administration,accounting for75.70%.Most ADRs were caused by antimicrobial drugs,accounting for 58.88%.ADRs of Cefuroxime accounted for11.54%,the first in list of suspicious drugs for ADRs.Nearly all of the systems were affected by these ADRs with broadly varied clinical symptoms.Skin and its appendages were the mostly suffered,accounting for 76.33%.Severe ADR ratio（22.00%）of combination therapy was higher than single drugs（10.07%）.According to pharmacological effects of suspicious drugs,ADRs were divided into type A,type B and type C.Type B occupied the highest proportion of 82.25%.Type B ADRs had the most definite temporal relationship,and 87.77% of type B ADRs were observed within2 hours after medication.Type A ADRs had the highest new and severe reports.CONCLUSION ADRs incidence after intravenous medication is higher than the other administration routes.Severe ADRs tend to occur within several minutes after medication.Drug combination is an important risk factor for serious ADRs.Type B ADRs account for the highest proportion,which may be correlated with its close temporal relationship.