摘要
目的对烟台市药品不良反应数据库严重不良反应(SADR)进行分析与评价,为临床安全、有效、合理用药和进一步深化药品安全监测工作提供参考,减少或预防不良反应的产生,以保障公众用药安全。方法提取烟台市药品不良反应数据库中2015年1月～2017年12月上报的3985例SADR报告进行数据清洗。采用描述性分析对患者的性别、年龄、既往病史、既往药品不良反应、药品种类、给药途径、药物剂型、累及系统/器官与临床表现、转归及对原患疾病的影响、停药减药反应和再次使用等进行分析。结果获得数据库中有效的SADR报告3030例。其中新的严重的SADR 675例(22.3%);占比最大的年龄组为60岁以上的患者(44.9%);静脉滴注是引起SADR的主要途径,占70.3%;大多数患者发生SADR后经停药及对症处理后痊愈(47.7%)或好转(47.3%);引起SADR频次较高的药物为抗感染药(26.8%)和抗肿瘤药(15.4%);SADR报告中以皮肤及粘膜损害为最多(22.3%)。结论 SADR发生较多且危害严重。本研究对严重不良反应报告进行了分析,为临床安全用药提供了参考,以减少不良反应的发生。
Objective The analysis and evaluation of serious adverse drug reactions(SADR)in Yantai city adverse drug reaction database were carried out to provide reference for clinical safety,effective and rational drug use and further deepening drug safety monitoring,reduce or prevent the occurrence of adverse reactions,so as to ensure the safety of public medication.Methods From January 2015 to December 2017,3985 SADR reports reported in Yantai city adverse drug reactions database were extracted for data cleaning.Descriptive analysis was used to analyze the gender,age,past medical history,past adverse drug reactions,drug types,drug delivery routes,drug dosage forms,involvement of system/organ and clinical manifestations,outcome and impact on the original disease,drug withdrawal and drug reduction reactions,and re-use of the patients.Results There were 3030 valid SADR reports in the database.Among them,there were 675 new serious SADR cases(22.3% ).The age group with the largest proportion was patients over 60 years old(44.9% ).Intravenous drip was the main cause of SADR,accounting for 70.3% .After SADR's occurrence,most patients recovered(47.7% )or improved(47.3% )after drug withdrawal and symptomatic treatment.The drugs causing SADR's high frequency were anti-infective drugs(26.8% )and anti-tumor drugs(15.4% ).According to SADR,skin and mucosal lesions were the most common(22.3% ).Conclusion SADR occurs more and is seriously harmful.This study analyzes the report of serious adverse reactions and provides a reference for clinical safe medication to reduce the occurrence of adverse reactions.
作者
丁月霞
李硕硕
周芙蓉
胡晓帆
刁瑞刚
DING Yue-xia;LI Shuo-shuo;ZHOU Fu-rong;HU Xiao-fan;DIAO Rui-gang(Department of Pharmacy,Yantai Yuhuangding Hospital,Shandong Province,Yantai 264000,China;College of Pharmacy,Yantai University,Shandong Province,Yantai 264003,China)
出处
《中国当代医药》
2019年第13期193-197,共5页
China Modern Medicine
