国内外儿科超说明书用药近况的系统评价  

A systematic review of off-label drug use at home and abroad for pediatrics

作　　者：李亚昙[1] 贾琳[1] 滕亮[2] 

机构地区：[1]新疆医科大学第二附属医院药学部,新疆乌鲁木齐830028 [2]新疆医科大学第一附属医院药学部,新疆乌鲁木齐830011

出　　处：《中国医院药学杂志》2016年第23期2114-2119,共6页Chinese Journal of Hospital Pharmacy

基　　金：新疆医科大学科研创新基金项目(编号:XYDCX201447)

摘　　要：目的：系统评价国内外儿童超说明书用药现状。方法：计算机检索PubMed、EMbase、CBM、CNKI和VIP数据库,纳人中、英文发表的0-18岁住院儿童超说明书用药研究,以Combieg工具评价纳入研究质量,描述性分析2011年至今全球住院/门诊和各年龄段儿童超说明书用药发生率,比较各类超说明书用药构成比。结果：共纳入16个横断面研究,国内外儿童超说明书用药研究主要集中在发达地区,不同地区发生率在9.01%-79%,不同年龄段儿童发生率不一致,超说明书用药类型主要集中在超年龄及超剂量用药方面。结论：超说明书用药在全球儿科普遍存在,不同国家发生率差异大;临床医师应当慎重考虑＂超说明书用药＂,加强自身素养,做好患儿知情同意,与临床药师及相关行政管理部门全力配合,以保障患儿用药安全,避免医疗风险。OBJECTIVE To assess present situations of off-1abel drug use at home and abroad for pediatrics.METHODSLiteratures were searched from databases such as PubMed,EMbase,CBM,CNKI and VIP to collect data on off-label drug use at home and abroad for pediatrics in2011,for children of 0to 18 years.Publication languages were limited to English and Chinese.Quality assessment was based on Crombie criteria for cross-sectional studies.Incidence of off-1abel drug use was described in different wards and age groups,and proportion of different off-1abel used drugs was analyzed.RESULTS Totally 16cross-sectional studies were included.Study on drug use for children at home and abroad mainly concentrated in developed regions,incidence rate was 9.01%-79%in different regions,rare consistence of incidence was observed in children of different ages,and type of off-label drug use was mainly concentrated in age and dose related off-label drug use.CONCLUSION Off-label drug use exists widely around the world,with incidence varying greatly in different countries.Clinicians should carefully consider use of drug and increase their knowledge,do good informed consent and cooperate with relevant administrative departments,thus ensure medical safety and avoid medical risks in children.

关 键 词：儿童 儿科 超说明书 系统评价 

分 类 号：R969[医药卫生—药理学]