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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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

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.	《中国脑卒中防治报告》编写组. 《中国脑卒中防治报告2019》概要. 中国脑血管病杂志, 2020, 17(5): 272-281.
3.	中华中医药学会脑病分会, 广东省中医药学会脑病专业委员会, 广东省中西医结合学会卒中专业委员会. 中西医结合脑卒中循证实践指南(2019). 中国循证医学杂志, 2020, 20(8): 901-912.
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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.	国家卫生计生委脑卒中防治工程委员会. 中国缺血性中风中成药合理使用指导规范. 2017: 1-32.
7.	张晋霞, 张志勇, 刘斌, 等. 重组组织型纤溶酶原激活剂联合中成药治疗缺血性脑卒中的荟萃分析. 中西医结合心脑血管病杂志, 2018, 16(9): 1253-1256.
8.	闫晨, 马德邻, 马妍, 等. 治疗缺血性脑卒中中成药的临床分析. 中国老年学杂志, 2016, 36(17): 4190-4192.
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11.	孙欣然, 万和平, 韩裕乐, 等. 基于德尔菲法和层次分析法的功能社区家庭医生签约服务项目体系及权重研究. 中国全科医学, 2022: 1-7. Available at: http://kns.cnki.net/kcms/detail/13.1222.R.20210906.1637.018.html.
12.	张宇斐, 柴建军, 胡冰水, 等. 基于德尔菲法和层次分析法的现代医院门诊医疗质控指标体系构建与应用. 中国医院, 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, 文进, 严玲, 等. 基于分级诊疗的患者信任度评价指标体系的构建. 中国循证医学杂志, 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.	孙欣然, 孙金海. 运用德尔菲法和层次分析法构建基于基本能力和基本状态的养老照护评估指标体系. 实用心脑肺血管病杂志, 2018, 26(2): 58-62.
18.	孙振球, 徐勇勇. 医学统计学. 北京: 人民卫生出版社, 2014.
19.	邓雪, 李家铭, 曾浩健, 等. 层次分析法权重计算方法分析及其应用研究. 数学的实践与认识, 2012, 42(7): 93-100.
20.	董君. 层次分析法权重计算方法分析及其应用研究. 科技资讯, 2015, 13(29): 218-220.
21.	曾光. 现代流行病学. 北京: 气象出版社, 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, 母东煜, 龚杰, 等. 应用德尔菲法初步完善特殊医学用途配方食品综合评价指标体系: 以2型糖尿病为例. 中国循证医学杂志, 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.	张艾嘉, 王爽, 王萍, 等. 缺血性脑卒中的病理机制研究进展及中医药防治. 中国实验方剂学杂志, 2020, 26(5): 227-240.
28.	张先卓, 吕萌, 罗旭飞, 等. 脑卒中康复临床实践指南推荐意见研究. 中国康复理论与实践, 2020, 26(2): 170-180.
29.	邱瑞瑾, 孙杨, 钟长鸣, 等. 中医核心证候指标集的构建思路. 中国循证医学杂志, 2021, 21(11): 1353-1357.
30.	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.

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. 《中国脑卒中防治报告》编写组. 《中国脑卒中防治报告2019》概要. 中国脑血管病杂志, 2020, 17(5): 272-281.
3. 中华中医药学会脑病分会, 广东省中医药学会脑病专业委员会, 广东省中西医结合学会卒中专业委员会. 中西医结合脑卒中循证实践指南(2019). 中国循证医学杂志, 2020, 20(8): 901-912.
4. 中国中西医结合学会神经科专业委员会. 中国脑梗死中西医结合诊治指南(2017). 中国中西医结合杂志, 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. 国家卫生计生委脑卒中防治工程委员会. 中国缺血性中风中成药合理使用指导规范. 2017: 1-32.
7. 张晋霞, 张志勇, 刘斌, 等. 重组组织型纤溶酶原激活剂联合中成药治疗缺血性脑卒中的荟萃分析. 中西医结合心脑血管病杂志, 2018, 16(9): 1253-1256.
8. 闫晨, 马德邻, 马妍, 等. 治疗缺血性脑卒中中成药的临床分析. 中国老年学杂志, 2016, 36(17): 4190-4192.
9. 国家医保局, 人力资源社会保障部. 关于印发《国家基本医疗保险、工伤保险和生育保险药品目录(2021年)》的通知. Available at: http://www.nhsa.gov.cn/art/2021/12/3/art_37_7429.html.
10. 中华人民共和国中央人民政府. 2018年版国家基本药物目录总品种数增至685种. Available at: http://www.gov.cn/xinwen/2018-09/05/content_5319574.htm.
11. 孙欣然, 万和平, 韩裕乐, 等. 基于德尔菲法和层次分析法的功能社区家庭医生签约服务项目体系及权重研究. 中国全科医学, 2022: 1-7. Available at: http://kns.cnki.net/kcms/detail/13.1222.R.20210906.1637.018.html.
12. 张宇斐, 柴建军, 胡冰水, 等. 基于德尔菲法和层次分析法的现代医院门诊医疗质控指标体系构建与应用. 中国医院, 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, 文进, 严玲, 等. 基于分级诊疗的患者信任度评价指标体系的构建. 中国循证医学杂志, 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. 孙欣然, 孙金海. 运用德尔菲法和层次分析法构建基于基本能力和基本状态的养老照护评估指标体系. 实用心脑肺血管病杂志, 2018, 26(2): 58-62.
18. 孙振球, 徐勇勇. 医学统计学. 北京: 人民卫生出版社, 2014.
19. 邓雪, 李家铭, 曾浩健, 等. 层次分析法权重计算方法分析及其应用研究. 数学的实践与认识, 2012, 42(7): 93-100.
20. 董君. 层次分析法权重计算方法分析及其应用研究. 科技资讯, 2015, 13(29): 218-220.
21. 曾光. 现代流行病学. 北京: 气象出版社, 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, 母东煜, 龚杰, 等. 应用德尔菲法初步完善特殊医学用途配方食品综合评价指标体系: 以2型糖尿病为例. 中国循证医学杂志, 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. 张艾嘉, 王爽, 王萍, 等. 缺血性脑卒中的病理机制研究进展及中医药防治. 中国实验方剂学杂志, 2020, 26(5): 227-240.
28. 张先卓, 吕萌, 罗旭飞, 等. 脑卒中康复临床实践指南推荐意见研究. 中国康复理论与实践, 2020, 26(2): 170-180.
29. 邱瑞瑾, 孙杨, 钟长鸣, 等. 中医核心证候指标集的构建思路. 中国循证医学杂志, 2021, 21(11): 1353-1357.
30. 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.

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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