2017~2019年某儿童医院药品不良反应/事件发生状况分析

Analysis of Adverse Drug Reactions/Eventsin a Children's Hospital from 2017 to 2019

目的:探讨本院药品不良反应/事件(adverse drug reaction/event,ADR/ADE)的发生状况,为儿科临床合理用药提供依据。方法:采用回顾性分析法,收集本院2017~2019年发生的578例ADR/ADE为研究对象,并对患儿的一般状况、涉及药品种类、高频药品及临床表现、ADR/ADE严重程度、对患儿原发疾病影响、是否超说明书用药等进行统计分析。结果:578例ADR/ADE中,男性患儿比例高于女性患儿(362/216),且随着年龄增长发生率逐渐降低;共涉及药品12类,98个品种,排名前5的药物依次为抗菌药、呼吸系统用药、中成药、抗病毒药、甾体激素类药;排名前5的药品为头孢他啶、异丙托溴铵、热毒宁注射液、阿糖腺苷和甲泼尼龙;按ADR/ADE的严重程度指数(adverse drug reaction severity index,SI_(ADR))归类,前5类包括抗癫痫药、辅助麻醉药、抗病毒药、甾体激素及辅助用药;ADR/ADE对原发疾病无明显影响542例(93.77%),造成住院时间延长31例(5.36%),造成永久伤害或危及生命5例(0.87%);超说明书用药导致ADE 75例,其中超年龄给药占比最高(54.67%)。结论:临床应重视儿童ADR/ADE,避免不合理用药尤其是不合理超说明书用药,确保儿童用药安全。

Objective:To provide evidence support for rational drug use in pediatric population,the occurrence of adverse drug reaction/event(ADR/ADE)in our hospital was explored in this paper.Methods:578 cases of ADR/ADE were gathered with a retrospective method in our children's hospital from 2017~2019.The general conditions,types of drugs involved,high-frequency drugs,clinical manifestations,severity of ADR/ADE,influence on primary diseases and off-label drug use was performed with a statistical analysis method.Results:Of the 578 cases,we observed that the proportion of male children was much higher than that of female children(362/216),and the incidence was gradually decreased with age increasing.A total of 12 categories,98 drugs were involved.The top five categories were consisted of antimicrobial agents,respiratory system drugs,proprietary Chinese medicine,antivirals and steroid hormone drugs.Among all kinds of drugs,the highest proportion was ceftazidime,ipratropium bromide,reduning injection,vidarabine and methylprednisolone;according to adverse drug reaction severity index(SI_(ADR)),the drug category was antiepileptics,anesthetics,antivirals,steroid hormones and adjuvant drugs in order.In terms of clinical outcomes,ADR/ADE had no effect on primary disease in 542 cases(93.77%),prolonged hospitalization in 31 cases(5.36%),resulted in permanent injury or life-threatening in 5 cases(0.87%).Among the ADE cases,75 cases were attributed to the off-label drug use,in which drug used for an unapproved age group accounted for the highest proportion(54.67%).Conclusion:The clinicians must pay great attention to the ADR/ADE in pediatric patients,and avoid irrational drug using(especially off-label drug use)in children.