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 off-label use; and d） Off-label use due to both ＂lack of instruction for children＂ and ＂over aged use＂ is more common. So it suggests that further studies trials should focus on fields in which clinical trials of dr11~r~ ~r~ tmtMh, ~hoo~＊
出处
《中国循证医学杂志》
CSCD
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)
关键词
儿童
超说明书用药
系统评价
用药安全
Outpatient children
Off-label
Systematic review
Drug safety
作者简介
张伶俐,女(1971年-),主任药师,以循证临床药学与药事管理学研究与实践、循证决策管理为主要研究方向。Email:zhlingli@sina.com;通讯作者:李幼平,Email:yzmylab@hotmail.com
