我院378例儿童药品不良反应报告分析

Analysis of 378 Cases of Pediatric ADR Report in Our Hospital

目的：了解我院儿童药品不良反应（ADR）发生的特点及规律,以促进医院儿童安全、合理用药。方法：采用回顾性分析方法,对我院2010-2014年上报国家ADR监测系统的378例儿童ADR报告进行统计、分析和评价。结果：在378例儿童ADR中,男性患儿255例（67.46%）,女性患儿123例（32.54%）;1~3岁年龄组患儿ADR发生率最高（27.51%）;静脉滴注是引发ADR的最主要给药途径,共331例（87.57%）;注射用无菌粉末是最主要剂型,有236例（62.43%）;引发ADR最多的药品品种是抗感染药（50.26%）,而抗感染药中又以头孢菌素类为主（43.68%）;ADR最常见的临床表现为皮肤及其附件损害（56.35%）,主要表现是皮疹、斑丘疹等过敏样反应;大部分ADR经过相关处理后能够痊愈或者好转（分别占64.29%和34.66%）。结论：儿童ADR的发生与给药途径、剂型、品种等多种因素密切相关,临床用药中需严格掌握药物的适应症、给药途径、方法、速度等,以促进临床合理用药,减少ADR的发生。

OBJECTIVE：To investigate the characteristics and regularity of pediatric adverse drug reactions（ADR）in our hospital in order to promote rational drug use of children. METHODS：In retrospective study,378 pediatric ADR cases collected from our hospital during 2010-2014 were analyzed statistically. RESULTS：Among 378 pediatric ADR cases,255 cases were male（67.46%）,and 123 cases were female（32.54%）;the incidence of ADR in patients aged from one year to three years were the highest（27.51%）;most of the cases were induced by intravenous injection,accounting for 87.57%（331 cases）;sterile powder for injection was main dosage form（236 cases,62.43%） anti-infective agents were the major cause of ADR in respect of drug types（50.26%）,among which cephalothin ranked the first place（43.68%）;the lesion of skin and its appendants were the most common clinical manifestation of ADR（56.35%）,such as erythra and pruritus. And most of the cases were cured（64.29%）or improved（34.66%）after treatment. CONCLUSIONS：The occurrence of ADR are related to multiple factors,such as administration route and drug varieties. Great importance should be attached to indication,route of adiminstration,method,speed and so on,in order to promote rational drug use and reduce the occurrence of ADR.