基于真实世界数据的儿童药品综合评价路径研究

Approach to Comprehensive Evaluation of Children's Medication Based on Real-world Data

目的针对我国儿童用药中存在的适宜药品不足、用药信息缺乏、说明书外用法及经验性用药普遍等临床问题,利用真实世界数据提供的重要证据资源,研究其应用于综合评价领域的实施路径,助力合理用药。方法采用案例分析方法,系统梳理本团队在儿童重点疾病用药领域主题遴选与综合评价的实践经验。结果探索并提出了应用真实世界数据开展儿童药品综合评价的研究路径与示范方法,并基于真实世界证据进一步规范儿科说明书外药品合理使用,支持儿童用药说明书外信息增补。结论本研究为真实世界数据应用于药品评价提供了参考依据,可促进儿科临床合理用药及相关药物决策制定。

Objective In view of the clinical problems of insufficient appropriate drugs,lack of medication information,widespread off-label and empirical drug use in children's medication in China,the important evidence resources provided by real world data are used to study the implementation path of its application in the field of comprehensive evaluation,and help rational drug use.Methods The case analysis method was used to systematically review the practical experience of our team in theme selection and comprehensive evaluation in the field of medication for children's key diseases.Results The research path and method of comprehensive evaluation of children's medication using real-world data were explored and proposed.The results of drug evaluation based on real-world evidence further supported the regulation of the clinical use of off-label drugs and the addition of information on drug use in pediatrics.Conclusion This study reference for drug evaluation using real world data and promotes rational drug use and related drug decision making in pediatrics.