湖北省12家哨点医院奥拉西坦注射液不良反应统计分析  

ADR Analysis of Oxiracetam Injection in Twelve Sentinel Monitoring Hospitals in Hubei Province

作　　者：赵丽 黄璞[2] 赵瑛 王慧 华小黎[2] ZHAO Li;HUANG Pu;ZHAO Ying;WANG Hui;HUA Xiao-li(Hubei Center for ADR Monitoring,Hubei Wuhan 430071,China;Department of Pharmacy,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Hubei Wuhan 430022,China)

机构地区：[1]湖北省药品医疗器械不良反应监测中心,湖北武汉430071 [2]华中科技大学同济医学院附属协和医院药学部,湖北武汉430022

出　　处：《中国药物警戒》2018年第1期36-40,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的分析奥拉西坦注射液的使用规律及安全性,为临床合理用药提供依据。方法湖北省纳入12家哨点医院,对观察期内(2016年9月1日~2017年3月31日)所有使用奥拉西坦注射剂的住院患者进行集中监测,并对患者的人口学信息、临床诊断、药物用法用量、疗程、溶媒、联合用药及不良反应(ADR)发生率进行分析,找出影响不良反应发生的风险因素。结果纳入的6 519份病例中,发生不良反应19例,不良反应发生率为0.29%。其中40~90岁之间的患者占90.31%。不良反应多发生在用药3天内(57.89%)。17例不良反应程度"轻度"(89.47%),新发现2例严重不良反应;累及器官以皮肤及其附件损害(皮疹)最为常见(36.84%)。经统计分析,不同性别、不同年龄段、不同剂型、有无过敏史、原患疾病的ADR发生率无统计学差异(P>0.05)。结论需要进一步完善药品说明书和规范临床用药。临床使用时,尤其需要关注用药疗程、剂量和溶媒。应加强患者用药监测,发生用药不适反应立即处置,保障患者用药安全。Objective To study using rules and safety of oxiracetam injection and provide reference for clinically reasonable application.Methods In twelve sentinel hospital of Hubei province,all hospitalized patients using oxiracetam injection were monitored centralizedly in observation period(September 1,2016 to March 31,2017).The patient's demographic information,clinical diagnosis,drug usage and dosage,course of treatment,solvent,combination and incidence of adverse drug reactions(ADRs)were analyzed,and the risk factors influencing ADRs were studied.Results A total of 6 519 cases were recorded.There were 19 cases of ADRs(0.29%).Patients aged 40 to 90 years accounted for 90.31%.ADRs occur mostly in 3 days after medication(57.89%).17 ADRs are mild(89.47%),and 2 ADRs are new and serious.Skin and appendages disorders(pruritus)are the most common(36.84%).Statistical analysis showed no significant difference(>0.05)in incidence rate of ADR between different genders,age groups,allergic history,diseases and dosage form.Conclusion The drug instructions and clinical medication need to further improved.In clinical use of oxiracetam injection,particular attention should be paid to the course of treatment,dosage and solvent.To avoid or reduce ADRs,it is important to closely observe patients'drug reactions and dispose immediately.

关 键 词：奥拉西坦注射液 不良反应 安全用药 集中监测 

分 类 号：R994.11[医药卫生—毒理学]