537例药品不良反应报告分析

Analysis of 537 case reports of adverse drug reactions

目的分析西安交通大学医学院附属西安市中心医院537例药品不良反应(ADR)情况。方法选取2017年1月~2018年12月医院发生ADR的537例患者,对其基本情况、给药途径、药物品种、药品种类分布、ADR累及器官或系统及临床表现、ADR报告类型分布及转归情况进行统计分析。结果537例ADR报告中,男288例,女249例,其中ADR事件:0~20岁占16.39%(88/537),>20~40岁占27.37%(147/537),>40~60岁占34.26%(184/537),>60岁占21.97%(118/537);静脉滴注占64.25%(345/537),是诱发ADR的主要给药途径;注射液占52.70%(283/537),是诱发ADR发生最多的剂型;抗感染药物导致的ADR事件发生率最高,占55.12%(296/537);ADR临床表现累及器官或系统最常见的为消化系统[37.62%(202/537)]、皮肤[22.35%(120/537)]及神经系统[21.42%(115/537)];537例ADR中,已知一般ADR占89.57%(481/537),新的一般的ADR占8.19%(44/537),已知严重的ADR占2.23%(12/537);全部患者经停药或根据症状治疗后,痊愈占24.39%(131/537),好转占48.42%(260/537),未好转占9.12%(49/537),不详占18.06%(97/537)。结论医院ADR发生与多种因素相关,老龄群体、静脉滴注给药途径、抗感染药物等应为医院药物使用时重点监测方向。

Objective To analyze 537 cases of adverse drug reactions(ADR)from Xi'an Central Hospital affiliated to Xi'an Jiaotong University School of Medicine.Methods A total of 537 patients with ADR in our hospital from January 2017-December 2018 were enrolled.The basic conditions,route of administration,drug type,drug type distribution,ADR-involved organs or systems and clinical manifestations,ADR-reported type distribution and outcomes in 537 cases of clinical adverse drug reactions were statistically analyzed.Results Among the 537 cases,288 were males and 249 were females.Among them,ADR events:0-20 years old accounted for 16.39%(88/537),>20-40 years old accounted for 27.37%(147/537),>40-60 years old accounted for 34.26%(184/537),and>60 years old accounted for 21.97%(118/537).Intravenous infusion accounted for 64.25%(345/537)was the main route of administration to induce ADR;injection 52.70%(283/537)was the most frequently induced ADR.The most common form of ADR events was caused by anti-infective drugs,55.12%(296/537);the most common clinical manifestations of ADR involving organs or systems were 37.62%(202/537),skin 22.35%(120/537),and nervous system 21.42%(115/537).Among the 537 cases of ADR,known general ADR accounted for 89.57%(481/537),new general ADR accounted for 8.19%(44/537),and known serious ADR accounted for 2.23%(12/537).After stopping medication or symptomatic treatment,the recovery accounted for 24.39%(131/537),the improvement accounted for 48.42%(260/537),not improved accounted for 9.12%(49/537),and unknown accounted for 18.06%(97/537).Conclusion The incidence of ADR in hospital drugs is related to multi-factors,in which the elderly population,intravenous infusion route,anti-infective drugs,etc.should be the key monitoring directions when hospital drugs are used.