中国药物评价
  • 中国核心期刊（遴选）数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2021, Vol. 38 ›› Issue (6): 479-483.

所属专题： 专栏——儿童药临床综合评价

• 专题 ——儿童药临床综合评价 • 上一篇    下一篇

儿童药品临床综合评价技术指南的研究与应用

  肖月，倪鑫2，王天有2，翟晓文3，黄敏4，付强1，游茂1，刘克军1，王晓玲2，孙华君4，赵瑞玲5，闫美兴6，王刚7，田金徽8，翟所迪9，张顺国10，邱英鹏1，史黎炜1，贾露露2，孙潭霖1，尉耘翠2，曹旺2，赵羽西1，赵琨1*   

  1. 1.国家卫生健康委卫生发展研究中心，北京100044； 2.国家儿童医学中心，首都医科大学附属北京儿童医院，北京 100045； 3.复旦大学附属儿科医院，上海 201102； 4.上海市儿童医院，上海交通大学附属儿童医院，上海 200062；  5.山西省儿童医院，山西省太原市 030013； 6.青岛市妇女儿童医院，山东青岛 266011； 7.重庆医科大学附属儿童医院，重庆 400014； 8.兰州大学循证医学中心，甘肃兰州 730000； 9.北京大学第三医院，北京大学医学部药物评价中心，北京 100191； 10.上海交通大学医学院附属上海儿童医学中心，上海 200127
  • 收稿日期:2021-10-25 修回日期:2021-11-23 出版日期:2021-12-28 发布日期:2021-12-28
  • 基金资助:
    国家卫生健康委药物政策与基本药物制度司“药品临床综合评价技术指南开发课题”（2019-98）

Research on Method Guidefor Pediatric Drug Evaluation

  1. 1.Health Development Research Center of National Health Committee， Beijing 100044， China;  2.National Children′s Medical Center， Beijing Children′s Hospital Affiliated to Capital Medical University，Beijing 100045， China;  3.The Children′s Hospital Affiliated to Fudan University，Shanghai 201102，China; 4.Shanghai Children′s Hospital， The Children′s Hospital Affiliated to Shanghai Jiao Tong University，Shanghai 200062，China; 5.Shanxi Children′s Hospital，Shanxi Taiyuan 030013，China;  6.Qingdao Women and Children′s Hospital，Shandong Qingdao 266011，China;  7.Children′s Hospital Affiliated to Chongqing Medical University，Chongqing 400014，China;  8.Lanzhou University Evidence-Based Medical Center，Gansu Lanzhou 730000，China;  9.Peking University Third Hospital，Beijing 100191，China; 10.Shanghai Children′s Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine，Shanghai 200127，China
  • Received:2021-10-25 Revised:2021-11-23 Online:2021-12-28 Published:2021-12-28
  • Contact: Kun wuZhao E-mail:zhaokun@nhei.cn

摘要： 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。

关键词: font-size:medium, ">儿童药品；临床综合评价；技术指南；试点

Abstract: 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. 

Key words: Pediatric medicine, Comprehensive evaluation, Method guide, Pilot

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