儿科超说明书用药指南/共识的循证评价  

Evidence-based evaluation for guidelines or consensus on pediatric off-label medication

作　　者：潘振宇[1,2] 王兆洁 成华 PAN Zhenyu;WANG Zhaojie;CHENG Hua(Department of Pharmacy,Xi’an Children’s Hospital,Xi’an 710003,China;Shaanxi Province Health Care Association,Xi’an 710061,China;Department of Pharmacy,Shaanxi Energy Institute,Xianyang 712000,Shaanxi Province,China)

机构地区：[1]西安市儿童医院药学部,西安710003 [2]陕西省保健学会,西安710061 [3]陕西能源职业技术学院药学系,陕西咸阳712000

出　　处：《药物流行病学杂志》2025年第4期428-436,共9页Chinese Journal of Pharmacoepidemiology

基　　金：陕西省保健学会药学服务科研基金(KY-2023-01-YX-01);陕西省自然科学基础研究计划(2020JQ-929)。

摘　　要：目的系统评价儿科超说明书用药指南和共识的质量,比较指南和共识间的差异,为临床应用提供参考。方法计算机检索TRIP、GIN、NICE、PubMed、CNKI、WanFang Data、医脉通等指南与文献数据库和网站,纳入儿科超说明书用药指南/共识,使用AGREEⅡ工具评价纳入指南/共识的方法学质量,分析各指南/共识推荐的异同,比较指南与共识、国外与国内指南/共识间各领域得分差异。结果共纳入7部指南/共识,其中指南3部、共识4部;1部来自奥地利,6部来自中国。AGREEⅡ评分结果显示,在六大领域的评分中,各指南/共识的范围和目的、参与人员得分均>60%,在制定的严谨性、清晰性、编辑的独立性和适用性4个领域中得分差异较大,各指南/共识不足的条目有差异。范围和目的领域的得分指南显著高于共识。此外,各指南/共识证据分级推荐系统不一致,包括GRADE标准、Micromedex标准、牛津循证医学中心标准和自定义标准。总体评价与推荐结果显示,3部指南/共识为推荐,3部为在不同程度上进行修改后推荐,1部为不推荐。结论现有儿科超说明书用药指南/共识数量较少,质量存在差异,证据质量和推荐强度标准不一致。Objective To systematically review the quality of pediatric off-label medication guidelines and consensus,compare the differences among guidelines and consensus,and to provide recommendations for clinical application.Method Searching the guidelines and literature databases and websites such as TRIP,GIN,NICE,PubMed,CNKI,WanFang Data,MedLink,to collect offlabel drug use guidelines or consensus.The AGREE II was used to evaluate the methodological quality of the included guidelines or consensus,and the differences among the recommendations of guidelines and consensus were analyzed and compared.The differences in scores between guidelines and consensus and international and domestic guidelines and consensus were compared in each domain.Results A total of 7 papers were included,comprising 3 guidelines and 4 consensuses,1 from Austria and 6 from China.The AGREE II results showed that the scores of 2 domains,“Scope and Purpose”and“Stakeholder Involvement”,were above 60%.There were significant differences in scores in the remaining four domains(Rigour of Development,Clarity of Presentation,Applicability,and Editorial Independence).There were differences in the insufficient items of the guidelines and consensus.The“Scope and Purpose”of the guidelines scored significantly higher than the consensus.In addition,the grading of evidence and grading of recommendations of the guidelines and consensus were different,including GRADE,Micromedex,Oxford Centre for Evidence-based Medicine standards,and custom methods.According to the AGREE II,among the 7 guidelines and consensus,3 were recommended,3 were recommended after modification,and 1 was not recommended.Conclusion There are relatively few existing pediatric guidelines and consensus on off-label medication.At present,there are differences in the quality of guidelines and consensus,with inconsistent standards for evidence quality and recommendation strength.

关 键 词：超说明书用药 儿童 指南 共识 系统评价 

分 类 号：R951[医药卫生—药学]