儿童药品临床综合评价技术指南的研究与应用

Research on Method Guidefor Pediatric Drug Evaluation

目的:进一步完善药品临床综合评价管理体系,支持临床合理用药决策,研究开发儿童药的临床综合评价技术指南。方法:儿童药品临床综合评价技术指南开发主要采取基于试点的实证研究方式,组织国家儿童医学中心等机构遴选儿童白血病、川崎病、退热、抗过敏等6个重点用药领域开展临床综合评价试点。结果:试点验证探索了主题遴选、评价设计实施、应用转化等关键路径和主要方法,为指南研发完善提供了依据。各试点医院已将试点研究结果进行院内转化并带动部分合作机构进行临床转化,形成了相关用药评价标准及方案,支持了临床合理用药决策制定。结论:药品临床综合评价是我国政府推动开展的一项开拓性创新工作,下一步将紧密结合“干中学”方式的试点实践,深入探索适宜的路径、机制和方法。

Objective:To support essential medicine policy and clinical decisions on medicine use,the National Health Commission has commissioned the development of medicine evaluation guides and relevant pilot projects.Methods:Empirical studies on 6 topic medicines have been conducted by the National Children′s Medical Center and other pediatric medical facilities to develop the evaluation guide on pediatric medicine.Results:The pilots explored key procedures and methods for topic selection,evaluation design and implementation,and policy translation.The method guide has been proofed and further developed based on the pilot findings.Pilot hospitals have applied evaluation findings into practical clinical decisions,and even promoted practices to other partner hospitals.The evaluation standard and protocol has formulated and contributed to medicine policy-making.Conclusion:Evaluation of essential medicine,including children′s medicine is innovative course taken by the Chinese government,and this endeavor needs to take a“learning by doing”approach and based on extensive pilot and practices,to explore suitable pathway and methods.