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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4.	藥物政策與基本藥物制度司. 關于藥品臨床綜合評價管理指南公開征求意見的公告. Available at: http://www.nhc.gov.cn/yaozs/s7656/202011/d11ddc32fae84121a0dfca36b015a31d.shtml.
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6.	張海力, 焦麗雯, 梁寧, 等. 基于綜合評價方法的多維度多準則優勢中成藥綜合評價指標體系構建研究. 中國中醫基礎醫學雜志, 2021, 27(3): 403-406.
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16.	盧杉杉, 沈愛宗. 藥物經濟學在臨床藥物治療學中的應用. 中國藥物經濟學, 2020, 15(5): 15-18.
17.	崔偉曦, 張黎媛, 劉靜, 等. 清熱類中藥注射劑的Mini衛生技術評估. 中成藥, 2020, 42(1): 262-270.
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19.	宋子揚, 尉耘翠, 聶曉璐, 等. 基于衛生技術評估聯合多準則決策分析建立我國兒童用藥臨床綜合評價方法. 藥物流行病學雜志, 2019, 28(10): 681-686.
20.	高海亮, 盧穎, 姜婷婷, 等. 藥物經濟學評價報告質量評估指南. 中國藥物經濟學, 2019, 14(2): 18-28.
21.	中國藥品綜合評價指南項目組. 中國藥品綜合評價指南參考大綱(第二版). 藥品評價, 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.	國家食品藥品監督管理局. 藥品說明書和標簽管理規定. Avaliable at: http://www.gov.cn/flfg/2006-03/16/content_228465.htm.
24.	國家中醫藥管理局. 關于印發中藥、天然藥物處方藥說明書格式內容書寫要求及撰寫指導原則的通知. Avaliable at: http://fjs.satcm.gov.cn/zhengcewenjian/2018-03-24/2624.html.

1. 國家衛生健康委辦公廳. 關于規范開展藥品臨床綜合評價工作的通知. 中華人民共和國國家衛生健康委員會公報, 2021, (7): 21-28.
2. 國家衛生健康委. 關于就《國家基本藥物目錄管理辦法(修訂草案)》公開征求意見的公告. Available at: http://www.nhc.gov.cn/wjw/yjzj/202111/068c31b85cb7486b9f77057b3e358aae.shtml.
3. 齊欣. 基藥目錄管理主推臨床綜合評價但非遴選唯一影響因子. 醫藥經濟報, 2021-12-13(001).
4. 藥物政策與基本藥物制度司. 關于藥品臨床綜合評價管理指南公開征求意見的公告. Available at: http://www.nhc.gov.cn/yaozs/s7656/202011/d11ddc32fae84121a0dfca36b015a31d.shtml.
5. 童榮生. 如何做好用好藥品臨床綜合評價. 健康報, 2020-07-17(005).
6. 張海力, 焦麗雯, 梁寧, 等. 基于綜合評價方法的多維度多準則優勢中成藥綜合評價指標體系構建研究. 中國中醫基礎醫學雜志, 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. 石秀園, 趙銳, 李璠, 等. 構建我國藥品臨床綜合評價工作機制的思考. 中國藥房, 2020, 31(23): 2828-2833.
16. 盧杉杉, 沈愛宗. 藥物經濟學在臨床藥物治療學中的應用. 中國藥物經濟學, 2020, 15(5): 15-18.
17. 崔偉曦, 張黎媛, 劉靜, 等. 清熱類中藥注射劑的Mini衛生技術評估. 中成藥, 2020, 42(1): 262-270.
18. 李洪, 王小巖, 岳曉萌, 等. 關于中國開展孤兒藥衛生技術評估的思考. 國際藥學研究雜志, 2019, 46(9): 666-672.
19. 宋子揚, 尉耘翠, 聶曉璐, 等. 基于衛生技術評估聯合多準則決策分析建立我國兒童用藥臨床綜合評價方法. 藥物流行病學雜志, 2019, 28(10): 681-686.
20. 高海亮, 盧穎, 姜婷婷, 等. 藥物經濟學評價報告質量評估指南. 中國藥物經濟學, 2019, 14(2): 18-28.
21. 中國藥品綜合評價指南項目組. 中國藥品綜合評價指南參考大綱(第二版). 藥品評價, 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. 國家食品藥品監督管理局. 藥品說明書和標簽管理規定. Avaliable at: http://www.gov.cn/flfg/2006-03/16/content_228465.htm.
24. 國家中醫藥管理局. 關于印發中藥、天然藥物處方藥說明書格式內容書寫要求及撰寫指導原則的通知. 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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