全球住院儿童超说明书用药现状的系统评价

Off-label Drug Use in Hospitalized Children:A Systematic Review

目的系统评价国内外住院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,描述性分析各病房和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29个横断面研究,合计8?560例住院儿童,41?655条医嘱。①各病房超说明书用药发生率中位数(四分位数间距):新生儿ICU 52.5%(23.0%～44.8%),儿科ICU 43.5%(34.5%～60%),普通儿科35.5%(23.8%～43.3%),儿科手术病房27.5%(23.0%～44.8%);②各研究报告不同年龄段超说明书用药发生率大小不一致;③超说明书用药类型构成比依次为无儿童用药信息(7%～54%)、超剂量和疗程(8%～86%)及超年龄用药(3%～67%)。结论①超说明书用药在全球儿科和新生儿病房普遍存在,不同国家和病房报告的超说明书用药发生率差异大;②超说明书用药发生率在ICU中可能高于非ICU,新生儿病房可能高于儿科病房;③"无儿童用药信息"的超说明书用药最常见,将来的儿科临床试验应重点关注高质量儿童用药证据完全空白的领域。④建议将来超说明书用药研究应统一设计,并尽快立项开展我国住院儿童超说明书用药多中心研究,为政策制定提供基线证据。

Objective To assess the global situation of off-label drug use in hospitalized children.Methods The databases such as PubMed,EMbase,CBM,CNKI and VIP were searched to collect studies on off-label drug use in hospitalized children at age of 0 to 18 years old.The publication language was limited to English and Chinese.The quality assessment was based on Crombie Criteria for cross-sectional studies.The incidence of off-label drug use was described in different wards and age groups,and the proportion of different off-label used drugs was analyzed.Results The total 29 cross-sectional studies were included,involving 8？560 children and 41？655 prescriptions.a） Median（IQR） of off-label use incidence： Neonatal ICU 52.5%（23.0% to 44.8%）,Pediatric ICU 43.5%（34.5% to 60%）,General pediatric ward 35.5%（23.8% to 43.3%）,Pediatric surgical ward 27.5%（23.0% to 44.8%）;b） The results of off-label incidence in different age groups were inconsistent among different studies;and c） The off-label drug use for ＂no pediatric information＂ had the largest proportion,followed by dose and age.Conclusion a） Off-label drug use exists widely around the world,but the incidence varies a lot in different countries and different types of wards;b） The incidence of off-label drug use may be higher in ICU than in non-ICU,and higher in the neonatal ward than the pediatric ward;c） The off-label drug use for no pediatric information is the commonest type,and further clinical studies should focus on areas in which high quality evidence is totally absent;and d） The multi-center studies with unified design on off-label drug use in hospitalized children in China are urgently needed to provide evidence for policy-making.