全球门诊儿童超说明书用药现状的系统评价  

Conclusion Commonwealth orientation is the fundamental priOff-Label Drug Use in Outpatient Children:A Systematic Review

作　　者：张伶俐[1,2] 李幼平[1] 梁毅[2,3] 曾力楠[2] 刘怡[2,3] 

机构地区：[1]四川大学华西医院中国循证医学中心,成都610041 [2]四川大学华西第二医院药学部,成都610041 [3]四川大学华西药学院,成都610041

出　　处：《中国循证医学杂志》2012年第3期305-313,共9页Chinese Journal of Evidence-based Medicine

基　　金：十一五国家科技支撑计划重点项目;"乡镇卫生院药物配置与物流关键技术研究与产品开发";(编号:2008BAI65B22)

摘　　要：目的系统评价国内外门诊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。纳入中、英文发表的0～18岁门诊儿童超说明书用药研究,以Combieg工具评价研究质量,描述性分析各级医疗机构和各年龄段儿童超说明书用药发生率、常见超说明书用药种类及其构成比。结果共纳入20个横断面研究,合计1 933 760例儿童,5 262 573条医嘱。结果显示①各级医疗机构门诊超说明书用药发生率:初级医疗机构19.5%(IQR 13.5%,24.5%),三级医疗机构26.0%(IQR 24.0%,35.0%);②各研究一致报告新生儿、婴儿或青少年超说明书用药发生率最高,年龄居中的普通儿童最低;③半数以上研究将呼吸系统用药、全身用抗感染药、感觉器官和皮肤用药列为超说明书使用频率前5位;④有"无儿童用药信息"的超说明书用药分类的研究提示该类超说明书用药发生率最高,无该分类的研究提示超年龄用药发生率最高。结论①全球门诊儿童超说明书用药现象普遍存在,三级医疗机构发生率可能高于初级医疗机构,新生儿、婴儿和青少年可能高于其他年龄组儿童;②住院儿童超说明书用药发生率可能高于门诊;③呼吸系统用药、全身用抗感染药、感觉器官和皮肤用药的超说明书使用常见;④"无儿童用药信息"的超说明书用药和超年龄用药较常见。建议将来的研究应重点关注儿童(或某年龄段儿童)药物临床试验尚处空白的领域。Objective To assess the global situation of off-label drug use in outpatient children. Methods A search was conducted in PubMed, EMbase, CBM, CNKI and VIP for collecting studies on off-label drug use in outpatient children aged 0 to 18 years, and the publication language was limited to English and Chinese. The quality assessment was based on Crombie Criteria for cross-sectional studies, and the descriptive analysis was performed to analyze the incidence of off-label drug use at all levels of medical institutes and different age groups, the common types of off-label used drugs, and the constitution ratio of off-label use drugs. Results A total of 20 cross-sectional studies were included, involving 1 933 760 children and 5 262 573 prescriptions. The results of descriptive analysis showed： a） The incidence of off-label drug use in outpatient children in primary care and tertiary care institutes were 19.5% （IQR 13.5%, 24.5%） and 26.0% （IQR 24.0%, 35.0%）, respectively; b） The primary studies reported that neonate, infant and adolescent had the highest incidence of off-label drug use, while the other children had the lowest incidence; c） Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were listed as the top 5 frequently used off-label drugs by more than half of the studies; d） The studies with issue of＂lack of instruction for children＂ showed it was exactly the type with highest incidence of off- label use, while other studies without that issue showed the highest incidence was over aged off-label use. Conclusion a） Off-label drug use is common in outpatient children. The incidence of off-label drug use may be higher in tertiary care institutes than primary care institutes, and it is higher in neonate, infant and adolescent rather than other age groups of children; b） Incidence of off-label use may be higher in inpatient children than outpatient ones; c） Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were most common types of

关 键 词：儿童 超说明书用药 系统评价 用药安全 

分 类 号：R95[医药卫生—药学]