资讯

【国家】药品临床综合评价体系建设研究

2023.05.17
中国药物警戒

岳小林1, 鲁松2, 张兰3,*    

Research in the construction of comprehensive evaluation systems of drugs in China

YUE Xiaolin1, LU Song2, ZHANG Lan3,*    

摘要: 目的 综述药品临床综合评价体系建设的研究进展,探讨适合我国国情的药品临床综合评价体系,为我国药品临床综合评价工作的开展提供参考。方法 检索国内外关于药品综合评价体系建设的相关文献,梳理有关药品综合评价体系建设流程的最新进展。结果 英国和美国等国家的药品评价主要是以药品目录的制定和决策为目的,体系建设已有一定基础,药品遴选方式、评价指标和审校方法相对规范;我国基于医院药品遴选为目的的评价工作正在逐渐开展和完善,但评价体系的建设仍处在探索阶段。结论 药品综合评价体系的建设可包括几个方面,如建设专业的评价主体、规范的评价流程、适宜的评价指标体系、科学的评价方法、严格的审校体系等。

 

关键词: 药品评价, 药品临床综合评价, 综合评价体系

Abstract: Objective To summarize the research progress of clinical evaluation system construction, discuss the clinical evaluation system suitable for Chinese conditions, and provide reference for the development of clinical evaluation of drugs. Methods Domestic and foreign literature on the construction of comprehensive evaluation system was searched and the latest progress of the construction process of comprehensive evaluation system was reviewed. Results Such as the UK and the US, drug evaluation was mainly aimed at the formulation and decision of drug list. The system construction had a certain foundation, and drug selection methods, evaluation indexes and proofreading methods were relatively standardized.In our country, the evaluation based on hospital drugs selection is gradually developed and improved, but the evaluation system is still in the exploratory stage. Conclusion The construction of comprehensive drug evaluation system can include several aspects, such as the construction of professional evaluation subject, standardized evaluation process, appropriate evaluation index system, scientific evaluation method, strict review system.

Key words: drug evaluation, comprehensive drug evaluation, comprehensive evaluation system

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引用本文

岳小林, 鲁松, 张兰. 药品临床综合评价体系建设研究[J]. 中国药物警戒, 2023, 20(5): 530-535.

YUE Xiaolin, LU Song, ZHANG Lan. Research in the construction of comprehensive evaluation systems of drugs in China[J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 530-535.