Investigation and analysis of the application of core outcomes in clinical trials of Chinese and Western medicine on myocardial infarction_Chinese Journal of Evidence-Based Medicine

Authors：

CHEN Zhuo ^1,2 , WAN Siqi ³ , GUAN Zhiyue ^1,2 , ZHANG Xinyi ^1,2 , LIU Shuling ^1,2 , WANG Wenhui ⁴ ,  QIU Ruijin ^1,2 ,  SHANG Hongcai ^1,4,5

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Beijing University of Chinese Medicine, Beijing 100700, P. R. China;
2. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P. R. China;
3. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;
4. Hunan University of Chinese Medicine, Changsha 410208, P. R. China;
5. Beijing University of Chinese Medicine Dongfang Hospital, Beijing 100078, P. R. China;

Corresponding?author：

QIU Ruijin, Email: psddqxn@163.com; SHANG Hongcai, Email: shanghongcai@126.com

Keywords：

Core outcome set; Outcomes; Clinical trial; Methodology

DOI：

10.7507/1672-2531.202409141

Video：

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The use of core outcome sets reduces heterogeneity in the reporting of outcomes in clinical trials, increasing the value and significance of research. This paper first introduces and interprets “core outcome sets for myocardial infarction (COS-MI) in clinical trials of traditional Chinese medicine and Western medicine”, in order to help Chinese researchers better understand and use it. Second, this study surveyed the use of COS-MI in MI related clinical trials from January 1, 2023 to June 1, 2024, showing that 91% (10/11) of the 35 acute myocardial infarction clinical studies included reported core outcomes, and the median percentage of using core outcome sets was only 36% (4/11). As the publication time of the core outcome set is close to the literature search time, the understanding of domestic researchers about it is still unclear. Further research is needed to explore the application of core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine, providing a reference for its update and improvement.

Citation： CHEN Zhuo, WAN Siqi, GUAN Zhiyue, ZHANG Xinyi, LIU Shuling, WANG Wenhui, QIU Ruijin, SHANG Hongcai. Investigation and analysis of the application of core outcomes in clinical trials of Chinese and Western medicine on myocardial infarction. Chinese Journal of Evidence-Based Medicine, 2025, 25(2): 206-213. doi: 10.7507/1672-2531.202409141 Copy

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2. Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
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13. 邱瑞瑾, 孫楊, 胡嘉元, 等. 臨床研究中選擇結局指標測量工具的方法. 中國循證醫學雜志, 2018, 18(2): 238-243.
14. Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "core outcome set" - a practical guideline. Trials, 2016, 17(1): 449.
15. 楊繼, 張垚, 張運嬌, 等. 基于主成分分析的中醫藥治療慢性心力衰竭臨床隨機對照試驗核心結局指標研究. 中西醫結合心腦血管病雜志, 2021, 19(15): 2496-2509, 2515.
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26. 中國急性心肌梗死注冊研究組. 匹伐他汀與阿托伐他汀對急性心肌梗死伴糖代謝異常患者血脂與血糖水平影響的對比研究. 中國循環雜志, 2023, 38(9): 930-936.
27. 張標, 楊靜靜, 趙德軒, 等. 芪參益氣滴丸對T2DM合并AMI病人PCI術后心功能的影響. 中西醫結合心腦血管病雜志, 2023, 21(16): 3041-3046.
28. 楊永強, 吳婷玉, 姜子超, 等. 麝香通心滴丸對STEMI急診PCI圍術期病人冠狀動脈微循環及心肌梗死面積的影響. 中西醫結合心腦血管病雜志, 2023, 21(10): 1881-1885.
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30. 錢賡, 陳思, 姜瀟思, 等. 注射用尼可地爾對于急性心肌梗死患者直接經皮冠狀動脈介入治療后對比劑腎病預防效果的臨床研究. 中國介入心臟病學雜志, 2024, 32(3): 136-140.
31. 高景芳, 李莉, 耿學斌, 等. 重組人尿激酶原對ST段抬高型心肌梗死患者急診介入治療術后無復流現象及預后的影響. 中華老年心腦血管病雜志, 2024, 26(4): 385-388.
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Chinese Journal of Evidence-Based Medicine

Investigation and analysis of the application of core outcomes in clinical trials of Chinese and Western medicine on myocardial infarction

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