中国中药杂志

2020, v.45(16) 3749-3758

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应用卫生技术评估开展中成药临床综合评价
Study on establishing a methodology of comprehensive clinical evaluation for Chinese patent medicine based on health technology assessment

廖星;郭武栋;曹庄;许海玉;张允岭;赵晖;王永炎;
LIAO Xing;GUO Wu-dong;CAO Zhuang;XU Hai-yu;ZHANG Yun-ling;ZHAO Hui;WANG Yong-yan;Center for Evidence Based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;Division of Appraisal and Transformation,Department of Health Technology Assessment,China National Health Development Research Center,National Health Commission;Institute of National Healthcare Security Administration,Capital Medical University;Institute of Chinese Materia Medica,Chin

摘要(Abstract):

目前中成药大多存在科学基础薄弱,临床价值评估不清等问题,使得中成药进入基本药物目录、医保目录等重要的卫生资源调配工具缺乏充分证据,对中医药行业的发展造成不利影响。为促进中成药的临床合理用药,遴选决策依据客观,充分凸显其临床价值,我国亟需建立中成药临床综合评价方法学体系。卫生技术评估(HTA)的流程和方法可为我国中成药临床综合评价方法的建立提供借鉴,但目前中医药研究领域鲜有开展HTA研究。国内外最新研究表明HTA结合多准则决策分析(MCDA)能够增加决策的透明度并提高决策质量,有利于药物的遴选和临床使用。该研究拟引入HTA联合MCDA形成的证据决策框架,建立我国中成药临床综合评价体系的方法学框架,并提出初步研究思路。未来,可联合国家相关药品决策部门和管理部门,确立一套中成药临床综合评价方法,推动中成药再评价工作全面实施。
At present, most of Chinese patent medicines have problems, such as weak scientific basis, unclear clinical value evaluation, etc., which lead to the lack of sufficient evidence for the entry into the essential medicine list, medical insurance catalog and other important health resource allocation tools. This has a negative impact on the development of traditional Chinese medicine. It is urgent to establish a comprehensive evaluation methodology system of Chinese patent medicine in China. There are at least three reasons including producing evidence for clinical rational use scientifically, developing an objective and transparent selecting strategy, eventuating and highlighting its clinical value. The process and method of health technology assessment(HTA) can provide reference for the establishment of comprehensive evaluation method of Chinese patent medicine. However, HTA is rarely carried out in the field of traditional Chinese medicine. The latest domestic and international research showed that HTA combined with multi-criteria decision analysis(MCDA) can increase the transparency of decision-making and improve the quality of decision-making. The combined two formed the EVIDEM framework, which is conducive to drug selection and its clinical use. In this paper, the EVIDEM framework was introduced to establish the methodology framework of the comprehensive clinical evaluation system of Chinese patent medicine. A preliminary research idea has been put forward. In the future, we can establish a set of comprehensive clinical evaluation methods for Chinese patent medicine in cooperation with relevant national drug decision-making departments and management departments. It is believed that such cooperation could promote the full implementation of the re-evaluation for Chinese patent medicine.

关键词(KeyWords): 中成药;药物综合评价;卫生技术评估;多准则决策分析;EVIDEM框架
Chinese patent medicine;drug comprehensive evaluation;health technology assessment;multi-criteria decision analysis;EVIDEM

Abstract:

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基金项目(Foundation): 国家中医药管理局医政司“医保支付的中医病种遴选和梳理的研究进展”项目(GZY-YZS-2018-04)

作者(Author): 廖星;郭武栋;曹庄;许海玉;张允岭;赵晖;王永炎;
LIAO Xing;GUO Wu-dong;CAO Zhuang;XU Hai-yu;ZHANG Yun-ling;ZHAO Hui;WANG Yong-yan;Center for Evidence Based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;Division of Appraisal and Transformation,Department of Health Technology Assessment,China National Health Development Research Center,National Health Commission;Institute of National Healthcare Security Administration,Capital Medical University;Institute of Chinese Materia Medica,Chin

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