Interpretation of the guideline for multi-dimensional and multi-criteria comprehensive evaluation for Chinese patent medicine_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Haili ¹ , LIANG Ning ¹ , CHEN Yaxin ¹ , LI Xiaoling ² , JIAO Liwen ¹ , LIU Guoxiu ³ , YANG Yijiu ¹ , WANG Jingya ¹ , LI Huizhen ¹ , ZONG Xingyu ¹ , WANG Weili ¹ , ZHAO Chen ¹ , LV Cheng ¹ , WANG Yanping ¹ ,  SHI Nannan ¹

1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
2. Shaanxi University of Chinese Medicine, Xianyang 712046, P. R. China;
3. Beijing University of Chinese Medicine, Beijing 100029, P. R. China;

Corresponding author：

SHI Nannan, Email: 13811839164@vip.126.com

Keywords：

Chinese patent medicine; Comprehensive evaluation; Guideline; Evaluation system

DOI：

10.7507/1672-2531.202203099

Video：

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A comprehensive evaluation system of Chinese patent medicine (CPM) is considered as a critical tool to measure the value of CPM. The "guideline for multi-dimensional and multi-criteria comprehensive evaluation for Chinese patent medicine" (abbreviated as guideline) has been released, proposing a comprehensive evaluation system of CPM (1^st) comprising six aspects: safety, effectiveness, economy, applicability, scientificity and standardization. This paper elaborated the development method and explained the evaluation dimensions and criteria, so as to help the researchers understand and use the comprehensive evaluation system in the future when evaluating CPM.

Citation： ZHANG Haili, LIANG Ning, CHEN Yaxin, LI Xiaoling, JIAO Liwen, LIU Guoxiu, YANG Yijiu, WANG Jingya, LI Huizhen, ZONG Xingyu, WANG Weili, ZHAO Chen, LV Cheng, WANG Yanping, SHI Nannan. Interpretation of the guideline for multi-dimensional and multi-criteria comprehensive evaluation for Chinese patent medicine. Chinese Journal of Evidence-Based Medicine, 2022, 22(7): 762-767. doi: 10.7507/1672-2531.202203099 Copy

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16.	卢杉杉, 沈爱宗. 药物经济学在临床药物治疗学中的应用. 中国药物经济学, 2020, 15(5): 15-18.
17.	崔伟曦, 张黎媛, 刘静, 等. 清热类中药注射剂的Mini卫生技术评估. 中成药, 2020, 42(1): 262-270.
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19.	宋子扬, 尉耘翠, 聂晓璐, 等. 基于卫生技术评估联合多准则决策分析建立我国儿童用药临床综合评价方法. 药物流行病学杂志, 2019, 28(10): 681-686.
20.	高海亮, 卢颖, 姜婷婷, 等. 药物经济学评价报告质量评估指南. 中国药物经济学, 2019, 14(2): 18-28.
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24.	国家中医药管理局. 关于印发中药、天然药物处方药说明书格式内容书写要求及撰写指导原则的通知. Avaliable at: http://fjs.satcm.gov.cn/zhengcewenjian/2018-03-24/2624.html.

1. 国家卫生健康委办公厅. 关于规范开展药品临床综合评价工作的通知. 中华人民共和国国家卫生健康委员会公报, 2021, (7): 21-28.
2. 国家卫生健康委. 关于就《国家基本药物目录管理办法(修订草案)》公开征求意见的公告. Available at: http://www.nhc.gov.cn/wjw/yjzj/202111/068c31b85cb7486b9f77057b3e358aae.shtml.
3. 齐欣. 基药目录管理主推临床综合评价但非遴选唯一影响因子. 医药经济报, 2021-12-13(001).
4. 药物政策与基本药物制度司. 关于药品临床综合评价管理指南公开征求意见的公告. Available at: http://www.nhc.gov.cn/yaozs/s7656/202011/d11ddc32fae84121a0dfca36b015a31d.shtml.
5. 童荣生. 如何做好用好药品临床综合评价. 健康报, 2020-07-17(005).
6. 张海力, 焦丽雯, 梁宁, 等. 基于综合评价方法的多维度多准则优势中成药综合评价指标体系构建研究. 中国中医基础医学杂志, 2021, 27(3): 403-406.
7. Chen Y, He Y, Chi X, et al. Development of health technology assessment in China: New challenges. Biosci Trends, 2018, 12(2): 102-108.
8. Di Bello V, Tonti G, Barletta G, et al. Introduction to health technology assessment. J Cardiovascul Echography, 2012, 22(3): 99-106.
9. Clifford S. HTA 101 introduction to health technology assessment. Available at: https://www.nlm.nih.gov/nichsr/hta101/HTA_101_FINAL_7-23-14.pdf.
10. WHO. Health technology assessment. Available at: https://www.who.int/health-technology assessment/about/healthtechnology/en/.
11. Teng F, Mitton C, Mackenzie J. Priority setting in the provincial health services authority: survey of key decision makers. BMC Health Serv Res, 2007, 7: 84.
12. Velazquez Berumen A, Jimenez Moyao G, Rodriguez NM, et al. Defining priority medical devices for cancer management: a WHO initiative. Lancet Oncol, 2018, 19(12): e709-e719.
13. Kumar S. Drug utilization review: types and roles. Pharmacoeconomics, 2021, 6(4): 1-2.
14. Institute for Clinical and Economic Review. Evaluating the value of new drugs and devices, 2015. Avaliable at: www. icerreview. org/wp-content/uploads/2014/01/Value-AssessmentFramework-9-71. pdf.
15. 石秀园, 赵锐, 李璠, 等. 构建我国药品临床综合评价工作机制的思考. 中国药房, 2020, 31(23): 2828-2833.
16. 卢杉杉, 沈爱宗. 药物经济学在临床药物治疗学中的应用. 中国药物经济学, 2020, 15(5): 15-18.
17. 崔伟曦, 张黎媛, 刘静, 等. 清热类中药注射剂的Mini卫生技术评估. 中成药, 2020, 42(1): 262-270.
18. 李洪, 王小岩, 岳晓萌, 等. 关于中国开展孤儿药卫生技术评估的思考. 国际药学研究杂志, 2019, 46(9): 666-672.
19. 宋子扬, 尉耘翠, 聂晓璐, 等. 基于卫生技术评估联合多准则决策分析建立我国儿童用药临床综合评价方法. 药物流行病学杂志, 2019, 28(10): 681-686.
20. 高海亮, 卢颖, 姜婷婷, 等. 药物经济学评价报告质量评估指南. 中国药物经济学, 2019, 14(2): 18-28.
21. 中国药品综合评价指南项目组. 中国药品综合评价指南参考大纲(第二版). 药品评价, 2015, 12(8): 6.
22. Drummond MF, Sculpher MJ, Claxton K, et al. Methods for the economic evaluation of care programs (4th edition). Oxford: Oxford University Press, 2015: 16-19.
23. 国家食品药品监督管理局. 药品说明书和标签管理规定. Avaliable at: http://www.gov.cn/flfg/2006-03/16/content_228465.htm.
24. 国家中医药管理局. 关于印发中药、天然药物处方药说明书格式内容书写要求及撰写指导原则的通知. Avaliable at: http://fjs.satcm.gov.cn/zhengcewenjian/2018-03-24/2624.html.

Chinese Journal of Evidence-Based Medicine

Interpretation of the guideline for multi-dimensional and multi-criteria comprehensive evaluation for Chinese patent medicine

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