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中成药上市后经济学评价指南

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在药品安全、有效的前提下,药物经济学评价可从不同的研究角度,为多样化的决策应用场景提供优选方案,最大限度地合理利用现有医疗卫生资源。传统中成药是我国重要的药品使用医疗资源,是我国医药费用支出的重要组成部分,但中成药上市后经济学评价较少,规范性较差,评价质量参差不齐,不能有效支持医药卫生决策,总体水平有待提高。针对这一现状,该项目汇集全国权威专家,严格遵循中华中医药学会团体标准的制定要求,制定了《中成药上市后经济学评价指南》(以下简称"该指南"),旨在为中成药上市后经济学评价提供通用的方法学指导,提高中成药经济学评价的规范性和研究结果的科学性,进而提高中成药上市后经济学评价的整体水平。该指南遵循我国相关法律法规和技术指导文件的框架,基于中医理论指导,注重中成药自身特点,从经济学评价基本原则、研究选题决策、研究问题界定、研究设计类型选择、成本识别与测量、健康产出的主要类型、评价方法等方面,对中成药上市后经济学评价中常见问题和难点提出方法学建议和决策建议。
Guidelines for economic evaluation of post-marketing Chinese patent medicine
With the premise of drug safety and effectiveness,pharmacoeconomic evaluation can provide optimal solutions for diversified decision-making application scenarios from different research perspectives while maximizing the rational utilization of existing healthcare resources.Chinese patent medicine is an essential component of pharmaceutical utilization in China and a significant part of healthcare expenditure in China.However,the economic evaluation of post-marketing Chinese patent medicine is lacking.These evaluations often lack standardization,exhibit varying quality,and are unable to effectively support healthcare decisions,indicating a need for improvement in overall quality.Given this situation,this project has gathered leading experts from China and has strictly adhered to the requirements of the group standards set by the China Association of Traditional Chinese Medicine in developing Guidelines for economic evaluation of post-marketing Chinese patent medicine,aiming to provide methodological guidance for the post-market pharmacoeconomic evaluation of Chinese patent medicine,enhancing the standardization of pharmacoeconomic evaluations of Chinese patent medicine and the scientific validity of research results,and thereby elevating the overall quality of pharmacoeconomic evaluations for post-marketing Chinese patent medicine.The guidelines adhere to the framework provided by relevant laws and regulations in China and technical guidance documents.It is based on guidance from traditional Chinese medicine(TCM)theories,focusing on the unique characteristics of TCM.It covers various aspects of pharmacoeconomic evaluation,including fundamental principles,research topic selection,research question definition,study design type selection,cost identification and measurement,health outcomes,and evaluation methods.The guidelines offer methodological recommendations and decision guidance to address common issues and challenges in the pharmacoeconomic evaluation of post-marketing Chinese patent medicine.

Chinese patent medicinepost-marketing researcheconomic evaluationguidelinegroup standard

史录文、谢雁鸣、聂小燕、韩晟、田夏、王志飞

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北京大学药学院药事管理与临床药学系,北京 100191

北京大学医药管理国际研究中心,北京 100191

中国中医科学院中医临床基础医学研究所,北京 100700

中成药 上市后研究 经济学评价 指南 团体标准

国家重点研发计划

2018YFC1707410

2024

中国中药杂志
中国药学会

中国中药杂志

CSTPCD北大核心
影响因子:1.718
ISSN:1001-5302
年,卷(期):2024.49(4)
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