中国儿童指南共识类文章中超说明书用药分析  

Analysis on off-label use of drugs in pediatric guidelines and consensus published by Chinese authors

作　　者：孟敏 王平 兰慧 雷文娟 申泉 周奇[2] 苏仁凤 吕萌 杨博[1] 罗旭飞 雷若冰 侯天春 李秋[1] 陈耀龙[5] Meng Min;Wang Ping;Lan Hui;Lei Wenjuan;Shen Quan;Zhou Qi;Su Renfeng;Lyu Meng;Yang Bo;Luo Xufei;Lei Ruobing;Hou Tianchun;Li Qiu;Chen Yaolong(Department of Pediatric Research Institute,Children′s Hospital of Chongqing Medical University,National Clinical Research Center for Child Health and Disorders,Chongqing 400014,China;Lanzhou University GRADE Center,Evidence-Based Medicine Center,School of Basic Medical Sciences,Lanzhou University,Lanzhou 730000,China;School of Public Health,Lanzhou University,Lanzhou 730000,China;Department of Pharmacy,Gansu Provincial Hospital,Lanzhou 730000,China;Research Unit of Evidence-Based Evaluation and Guidelines,Chinese Academy of Medical Sciences,School of Basic Medical Sciences,Lanzhou University,Lanzhou 730000,China)

机构地区：[1]重庆医科大学附属儿童医院儿科研究所国家儿童健康与疾病临床医学研究中心,重庆400014 [2]兰州大学基础医学院循证医学中心GRADE兰州大学中心,兰州730000 [3]兰州大学公共卫生学院,兰州730000 [4]甘肃省人民医院药剂科,兰州730000 [5]中国医学科学院循证评价与指南研究创新单元兰州大学基础医学院,兰州730000

出　　处：《中华儿科杂志》2022年第3期215-220,共6页Chinese Journal of Pediatrics

摘　　要：目的了解中国儿童指南推荐意见中超说明书用药的现状,为儿童超说明书用药推荐意见的规范化报告提供参考。方法横断面研究,通过系统检索PubMed、Embase、中国知网、万方数据库以及中国生物医学文献数据库,同时补充检索了医脉通指南数据库,以2018—2020年期刊发表的中国指南共识类文章为研究对象,提取其中超说明书用药推荐意见,分析纳入指南的基本特征以及超说明书药品品种和类别的排名、药品信息排名、超说明书用药类型和推荐依据的引文研究类型占比。结果纳入108篇包含超说明书用药推荐意见的中国指南共识类文章,共获取超说明书用药推荐意见364条。108篇文章中,48篇(44.4%)为中华医学会发布,疾病类型中14篇(13.0%)以感染性疾病或寄生虫病较为关注。364条超说明书用药的推荐意见中,药品品种有环孢素A 16条(4.4%)、甲氨蝶呤和芬太尼各11条(3.0%);药品类别主要为免疫系统用药68条(18.7%)、抗感染药66条(18.1%)和肿瘤用药56条(15.4%);药品信息有适应证364条(100.0%)、剂量204条(56.0%)、给药途径198条(54.4%);超说明类型有超适应证175条(48.1%)、超人群127条(34.9%)、超年龄72条(19.8%)。仅129条(35.4%)推荐意见标注引文,共追溯到205篇引证文献,其研究类型主要有临床指南48篇(23.4%)、综述22篇(10.7%)、儿童随机对照试验22篇(10.7%)。结论中国儿科指南共识类文章中,超说明书用药现象普遍,但是其推荐意见的报告差异较大,支撑证据质量欠佳。Objective To understand the current situation regarding pediatric off-label use of drugs recommendations in Chinese clinical practice guidelines and to make recommendations for standardized reporting format regarding off-label use of drugs for children.Methods This cross-sectional study was carried out by systematically searching the databases for Chinese guideline consensus articles published in journals between 2018 and 2020 and extracting recommendations regarding off-label use of drugs from those articles.The essential characteristics of the included guidelines,the ranking of off-label drug types,the order of drug information,the type of off-label drug use,and the percentage of citation studies on which the recommendations were based were analyzed.Results Among 108 studies that included Chinese off-label guidelines and consensus,364 recommendations on pediatric off-label use of drugs were included.The Chinese Medical Association published the most,48 out of the 108 studies(44.4%),and of those 14 studies(13.0%)were on infectious and parasitic diseases.Of the 364 recommendations on off-label use of drugs,the most commonly addressed drugs were 16 recommendations(4.4%)for cyclosporine A,11 recommendations(3.0%)for methotrexate,and 11 recommendations(3.0%)for fentanyl.The most commonly addressed drug categories were as follows:68 recommendations(18.6%)were immune system drugs,66 recommendations(18.1%)were anti-infectives,and 56 recommendations(15.4%)were oncology drugs.The most commonly addressed drug information accounts were as follows:364 recommendations(100.0%)were indications,204 recommendations(56.0%)were dosages,and 198 recommendations(54.4%)were the route of administration.Based on the instructions approved by the Chinese Food and Drug Administration,the main forms of the off-label drug were as follows:175 recommendations(48.1%)were unapproved indications,127 recommendations(34.9%)were unapproved populations,and 72 recommendations(19.8%)were unapproved ages.Only 129 recommendations(35.4%)were cited,mainly

关 键 词：儿童 超说明书用药 指南共识类文章 推荐意见 

分 类 号：R95[医药卫生—药学]