A study on the construction of the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke_Chinese Journal of Evidence-Based Medicine

Authors：

MA Yu ^1,2,3 , HUI Wen ⁴ , DENG Ke ^1,2,3 , QIN Xuan ^1,2,3 , LIU Yanmei ^1,2,3 , YAO Minghong ^1,2,3 , LI Dehua ⁵ , LI Lingxin ⁶ , WU Darong ^7,8 , GUO Xinfeng ⁷ ,  LI Ling ^1,2,3 ,  SUN Xin ^1,2,3

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu 610041, P. R. China;
3. Sichuan Center of Technology Innovation for Real World Data, Chengdu 610041, P. R. China;
4. Department of Science and Technology, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
5. Department of Acupuncture-Moxibustion and Rehabilitation, Affiliated Hospital of Chengdu University of TCM, Chengdu 610075, P. R. China;
6. Department of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
7. State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine/ Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, P. R. China;
8. Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, P. R. China;

Corresponding?author：

LI Ling, Email: liling@wchscu.cn; SUN Xin, Email: sunxin@wchscu.cn

Keywords：

Ischemic stroke; Chinese patent medicine; Comprehensive evaluation; Indicator system; Analytic hierarchy process

DOI：

10.7507/1672-2531.202204039

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To construct the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, to determine the weight of indicators, and to provide references for the comprehensive evaluation of the efficacy, safety, and economy of Chinese patent medicines.Methods Two rounds of expert consultation by Delphi method were applied to establish the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, and the weight of each indicator was determined by the analytic hierarchy process method.Results Questionnaire recovery rates of 2 rounds were 92.59% and 96.00%, the expert authority coefficient was greater than 0.7, and the coordination coefficients of experts in the total index were 0.224 and 0.370 (P<0.001). A three-level comprehensive evaluation indicator system for Chinese patent medicines for ischemic stroke was established and the three first-level indicators included efficacy, safety, and economy. And there were 15 second-level indicators, and 33 third-level indicators. Through the analytic hierarchy process method, the weights of each first-level indicator were 0.626 4, 0.301 2, and 0.072 4, respectively.Conclusion The comprehensive evaluation indicator system contains efficacy, safety and economy, and provides a basis for a comprehensive evaluation of Chinese patent medicines for ischemic stroke. The indicator system is of great significance for the design of outcomes for clinical trials of ischemic stroke, the conduction of systematic reviews, and the development of clinical practice guidelines for ischemic stroke patients when selecting study outcomes.

Citation： MA Yu, HUI Wen, DENG Ke, QIN Xuan, LIU Yanmei, YAO Minghong, LI Dehua, LI Lingxin, WU Darong, GUO Xinfeng, LI Ling, SUN Xin. A study on the construction of the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke. Chinese Journal of Evidence-Based Medicine, 2022, 22(9): 1055-1061. doi: 10.7507/1672-2531.202204039 Copy

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2.	《中國腦卒中防治報告》編寫組. 《中國腦卒中防治報告2019》概要. 中國腦血管病雜志, 2020, 17(5): 272-281.
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6.	國家衛生計生委腦卒中防治工程委員會. 中國缺血性中風中成藥合理使用指導規范. 2017: 1-32.
7.	張晉霞, 張志勇, 劉斌, 等. 重組組織型纖溶酶原激活劑聯合中成藥治療缺血性腦卒中的薈萃分析. 中西醫結合心腦血管病雜志, 2018, 16(9): 1253-1256.
8.	閆晨, 馬德鄰, 馬妍, 等. 治療缺血性腦卒中中成藥的臨床分析. 中國老年學雜志, 2016, 36(17): 4190-4192.
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10.	中華人民共和國中央人民政府. 2018年版國家基本藥物目錄總品種數增至685種. Available at: http://www.gov.cn/xinwen/2018-09/05/content_5319574.htm.
11.	孫欣然, 萬和平, 韓裕樂, 等. 基于德爾菲法和層次分析法的功能社區家庭醫生簽約服務項目體系及權重研究. 中國全科醫學, 2022: 1-7. Available at: http://kns.cnki.net/kcms/detail/13.1222.R.20210906.1637.018.html.
12.	張宇斐, 柴建軍, 胡冰水, 等. 基于德爾菲法和層次分析法的現代醫院門診醫療質控指標體系構建與應用. 中國醫院, 2021, 25(3): 36-39.
13.	Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Advan Nurs, 2000, 32(4): 1008-1015.
14.	陶文娟, 文進, 嚴玲, 等. 基于分級診療的患者信任度評價指標體系的構建. 中國循證醫學雜志, 2018, 18(8): 802-806.
15.	Diaz-Ledezma C, Parvizi J. Surgical approaches for cam femoroacetabular impingement: the use of multicriteria decision analysis. Clin Orthop Relat Res, 2013, 471(8): 2509-2516.
16.	Ijzerman MJ, van Til JA, Bridges JF. A comparison of analytic hierarchy process and conjoint analysis methods in assessing treatment alternatives for stroke rehabilitation. Patient, 2012, 5(1): 45-56.
17.	孫欣然, 孫金海. 運用德爾菲法和層次分析法構建基于基本能力和基本狀態的養老照護評估指標體系. 實用心腦肺血管病雜志, 2018, 26(2): 58-62.
18.	孫振球, 徐勇勇. 醫學統計學. 北京: 人民衛生出版社, 2014.
19.	鄧雪, 李家銘, 曾浩健, 等. 層次分析法權重計算方法分析及其應用研究. 數學的實踐與認識, 2012, 42(7): 93-100.
20.	董君. 層次分析法權重計算方法分析及其應用研究. 科技資訊, 2015, 13(29): 218-220.
21.	曾光. 現代流行病學. 北京: 氣象出版社, 2002.
22.	McPherson S, Reese C, Wendler MC. Methodology update: Delphi studies. Nurs Res, 2018, 67(5): 404-410.
23.	Korpershoek YJ, Bruins Slot JC, Effing TW, et al. Self-management behaviors to reduce exacerbation impact in COPD patients: a Delphi study. Int J Chron Obstruct Pulmon Dis, 2017, 12: 2735-2746.
24.	Seoane J, Warnakulasuriya S, Bagán JV, et al. Assembling a consensus on actinic cheilitis: a Delphi study. J Oral Pathol Med, 2021, 50(10): 962-970.
25.	石磊, 母東煜, 龔杰, 等. 應用德爾菲法初步完善特殊醫學用途配方食品綜合評價指標體系: 以2型糖尿病為例. 中國循證醫學雜志, 2020, 20(9): 1012-1019.
26.	GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the global burden of disease study 2016. Lancet Neurol, 2019, 18(5): 439-458.
27.	張艾嘉, 王爽, 王萍, 等. 缺血性腦卒中的病理機制研究進展及中醫藥防治. 中國實驗方劑學雜志, 2020, 26(5): 227-240.
28.	張先卓, 呂萌, 羅旭飛, 等. 腦卒中康復臨床實踐指南推薦意見研究. 中國康復理論與實踐, 2020, 26(2): 170-180.
29.	邱瑞瑾, 孫楊, 鐘長鳴, 等. 中醫核心證候指標集的構建思路. 中國循證醫學雜志, 2021, 21(11): 1353-1357.
30.	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.

1. Zhou M, Wang H, Zeng X, et al. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the global burden of disease study 2017. Lancet, 2019, 394(10204): 1145-1158.
2. 《中國腦卒中防治報告》編寫組. 《中國腦卒中防治報告2019》概要. 中國腦血管病雜志, 2020, 17(5): 272-281.
3. 中華中醫藥學會腦病分會, 廣東省中醫藥學會腦病專業委員會, 廣東省中西醫結合學會卒中專業委員會. 中西醫結合腦卒中循證實踐指南(2019). 中國循證醫學雜志, 2020, 20(8): 901-912.
4. 中國中西醫結合學會神經科專業委員會. 中國腦梗死中西醫結合診治指南(2017). 中國中西醫結合雜志, 2018, 38(2): 136-144.
5. Wang Y, Cui L, Ji X, et al. The China national stroke registry for patients with acute cerebrovascular events: design, rationale, and baseline patient characteristics. Int J Stroke, 2011, 6(4): 355-361.
6. 國家衛生計生委腦卒中防治工程委員會. 中國缺血性中風中成藥合理使用指導規范. 2017: 1-32.
7. 張晉霞, 張志勇, 劉斌, 等. 重組組織型纖溶酶原激活劑聯合中成藥治療缺血性腦卒中的薈萃分析. 中西醫結合心腦血管病雜志, 2018, 16(9): 1253-1256.
8. 閆晨, 馬德鄰, 馬妍, 等. 治療缺血性腦卒中中成藥的臨床分析. 中國老年學雜志, 2016, 36(17): 4190-4192.
9. 國家醫保局, 人力資源社會保障部. 關于印發《國家基本醫療保險、工傷保險和生育保險藥品目錄(2021年)》的通知. Available at: http://www.nhsa.gov.cn/art/2021/12/3/art_37_7429.html.
10. 中華人民共和國中央人民政府. 2018年版國家基本藥物目錄總品種數增至685種. Available at: http://www.gov.cn/xinwen/2018-09/05/content_5319574.htm.
11. 孫欣然, 萬和平, 韓裕樂, 等. 基于德爾菲法和層次分析法的功能社區家庭醫生簽約服務項目體系及權重研究. 中國全科醫學, 2022: 1-7. Available at: http://kns.cnki.net/kcms/detail/13.1222.R.20210906.1637.018.html.
12. 張宇斐, 柴建軍, 胡冰水, 等. 基于德爾菲法和層次分析法的現代醫院門診醫療質控指標體系構建與應用. 中國醫院, 2021, 25(3): 36-39.
13. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Advan Nurs, 2000, 32(4): 1008-1015.
14. 陶文娟, 文進, 嚴玲, 等. 基于分級診療的患者信任度評價指標體系的構建. 中國循證醫學雜志, 2018, 18(8): 802-806.
15. Diaz-Ledezma C, Parvizi J. Surgical approaches for cam femoroacetabular impingement: the use of multicriteria decision analysis. Clin Orthop Relat Res, 2013, 471(8): 2509-2516.
16. Ijzerman MJ, van Til JA, Bridges JF. A comparison of analytic hierarchy process and conjoint analysis methods in assessing treatment alternatives for stroke rehabilitation. Patient, 2012, 5(1): 45-56.
17. 孫欣然, 孫金海. 運用德爾菲法和層次分析法構建基于基本能力和基本狀態的養老照護評估指標體系. 實用心腦肺血管病雜志, 2018, 26(2): 58-62.
18. 孫振球, 徐勇勇. 醫學統計學. 北京: 人民衛生出版社, 2014.
19. 鄧雪, 李家銘, 曾浩健, 等. 層次分析法權重計算方法分析及其應用研究. 數學的實踐與認識, 2012, 42(7): 93-100.
20. 董君. 層次分析法權重計算方法分析及其應用研究. 科技資訊, 2015, 13(29): 218-220.
21. 曾光. 現代流行病學. 北京: 氣象出版社, 2002.
22. McPherson S, Reese C, Wendler MC. Methodology update: Delphi studies. Nurs Res, 2018, 67(5): 404-410.
23. Korpershoek YJ, Bruins Slot JC, Effing TW, et al. Self-management behaviors to reduce exacerbation impact in COPD patients: a Delphi study. Int J Chron Obstruct Pulmon Dis, 2017, 12: 2735-2746.
24. Seoane J, Warnakulasuriya S, Bagán JV, et al. Assembling a consensus on actinic cheilitis: a Delphi study. J Oral Pathol Med, 2021, 50(10): 962-970.
25. 石磊, 母東煜, 龔杰, 等. 應用德爾菲法初步完善特殊醫學用途配方食品綜合評價指標體系: 以2型糖尿病為例. 中國循證醫學雜志, 2020, 20(9): 1012-1019.
26. GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the global burden of disease study 2016. Lancet Neurol, 2019, 18(5): 439-458.
27. 張艾嘉, 王爽, 王萍, 等. 缺血性腦卒中的病理機制研究進展及中醫藥防治. 中國實驗方劑學雜志, 2020, 26(5): 227-240.
28. 張先卓, 呂萌, 羅旭飛, 等. 腦卒中康復臨床實踐指南推薦意見研究. 中國康復理論與實踐, 2020, 26(2): 170-180.
29. 邱瑞瑾, 孫楊, 鐘長鳴, 等. 中醫核心證候指標集的構建思路. 中國循證醫學雜志, 2021, 21(11): 1353-1357.
30. 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.

Chinese Journal of Evidence-Based Medicine

A study on the construction of the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke

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