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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (6): 619-627.doi: 10.3736/jcim20120604

Special Issue: Traditional Chinese Medicine

• Study Protocol • Previous Articles     Next Articles

Clinical epidemiology survey of the traditional Chinese medicine etiology and syndrome differentiation of coronary artery disease: Study protocol of a multicenter trial

Ying-fei Bi1,2, Jing-yuan Mao1,2(), Xian-liang Wang1,2, Ya-zhu Hou1,2, Yi-zhu 2,3,Bin Soh Shan4, Bo-li Zhang2,5   

  1. 1. Department of Cardiovascular Diseases, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
    2. National Clinical Research Center of Traditional Chinese Medicine on Coronary Artery Disease, Tianjin 300193, China
    3. Department of Diagnosis, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
    4. International Educational Center, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
    5. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
  • Received:2012-02-23 Accepted:2012-02-26 Online:2012-06-20 Published:2018-06-15
  • Contact: Jing-yuan Mao E-mail:jymao@126.com

Background: Coronary artery disease (CAD), a common disease with high incidence and mortality rate, has seriously threatened the health and life of the public. Traditional Chinese medicine (TCM) has an important role in the prevention and treatment of this disease. Through clinical epidemiological survey, a deeper understanding of TCM etiology and syndrome characteristics in CAD would further improve clinical efficacy in the treatment of this disease.
Methods/design: The preliminary clinical questionnaire for TCM etiology and syndrome differentiation in CAD was designed after literature reviews and analysis. Through a series of clinical pre-surveys, expert consultation and demonstration, the formal TCM clinical epidemiology questionnaire on the etiology and syndrome differentiation in CAD was finalized, after which, the study protocol, inclusive and exclusive criteria and related quality control measures were prepared. The multiregional clinical epidemiological survey with more than 5 000 participants with CAD will be carried out in 41 TCM hospitals of China for investigating the TCM etiology and syndrome differentiation of CAD.
Discussion: Multiregion large sample size clinical epidemiology survey on TCM etiology and syndrome differentiation in CAD will provide further evidence in preventing CAD and improving the standardization process of syndrome research.

Key words: coronary artery disease, traditional Chinese medicine, etiological factors (TCM), symptom complex, epidemiologic studies, questionnaires, multicenter study, clinical protocols

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Code Partners
001 First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
002 Dongfang Hospital of Beijing University of Chinese Medicine
003 Third Affiliated Hospital of Beijing University of Chinese Medicine
004 The Affiliated Hospital to Changchun University of Chinese Medicine
005 Teaching Hospital of Chengdu University of TCM
006 University Hospital of Gansu Traditional Chinese Medicine
007 Guangdong Second Provincial Traditional Chinese Medicine Hospital
008 Guangdong Hospital of Traditional Chinese Medicine
009 First Teaching Hospital of Guangzhou University of Chinese Medicine
010 The First Affiliated Hospital of Guangxi University of Chinese Medicine
011 Hainan Hospital of Traditional Chinese Medicine
012 TCM Hospital of Shijiazhuang City
013 The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
014 The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
015 Affilicated Hospital of Henan Province Chinese Medicine Research Institute
016 Henan Hospital of TCM (The Second Affiliated Hospital of Henan University of TCM)
017 Heilongjiang Academy of TCM
018 First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
019 Wuhan Integrated TCM and Western Medicine Hospital.
020 First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
021 Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
022 Affiliated Hospital of Jiangxi College of Traditional Chinese Medicine
023 Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
024 Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
025 The Third Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
026 Ningxia Institute of Traditional Chinese Medicine
027 Affiliated Hospital of Shandong University of Traditional Chinese Medicine
028 Shanxi Hospital of Traditional Chinese Medicine
029 Xi’an Hospital of Traditional Chinese Medicine
030 Shaanxi Hospital of Traditional Chinese Medicine
031 Second Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine
032 Longhua Hospital of Shanghai University of Traditional Chinese Medicine
033 Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
034 Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine
035 Beijing Hospital of Traditional Chinese Medicine of Capital Medical University
036 First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
037 Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
038 Affiliated Hospital of Tianjin Chinese Medicine Research Institute
039 TCM Hospital of Xinjiang Medical University
040 Guang’anmen Hospital of China Academy of Chinese Medical Sciences
041 Xiyuan Hospital of China Academy of Chinese Medical Sciences

Figure 1

The general process of clinical epidemiology survey of TCM etiology and syndrome differentiation of CAD TCM: traditional Chinese medicine; CAD: coronary artery disease."

[1] Wang JL, Wang BY. Clinical epidemiology.3rd ed[M]. Beijing: People’s Medical Publishing House, 2008: 2
王家良, 王滨有 . 临床流行病学.第3版[M]. 北京: 人民卫生出版社, 2008: 2
[2] He CR, Wang ZB . Application of clinical epidemiology survey in TCM syndrome study[J]. Zhongguo Zhong Yi Ji Chu Yi Xue Za Zhi, 2006,12(5):385-386
doi: 10.3969/j.issn.1006-3250.2006.05.028
贺春瑞, 王振彪 . 临床流行病学调查方法在中医证候研究中的应用[J]. 中国中医基础医学杂志, 2006,12(5):385-386
doi: 10.3969/j.issn.1006-3250.2006.05.028
[3] Tao HH. Traditional Chinese medicine etiology and pathogenesis[M]. Beijing: China Medical Science Press, 2002: 80-179
陶汉华 . 中医病因病机学[M]. 北京: 中国医药科技出版社, 2002: 80-179
[4] Wu DX. Basic theory of traditional Chinese medicine[M]. Shanghai: Shanghai Scientific and Technical Publishers, 1995: 122-169
吴敦序 . 中医基础理论[M]. 上海: 上海科学技术出版社, 1995: 122-169
[5] Zhu WF. Diagnostics of traditional Chinese medicine[M]. Beijing: China Press of Traditional Chinese Medicine, 2002: 176-181
朱文锋 . 中医诊断学[M]. 北京: 中国中医药出版社, 2002: 176-181
[6] Wang YY. Internal medicine of traditional Chinese medicine[M]. Shanghai: Shanghai Scientific and Technical Publishers, 1997: 68-240
王永炎 . 中医内科学[M]. 上海: 上海科学技术出版社, 1997: 68-240
[7] Cardiology Branch of Chinese Association of Integrative Medicine. Traditional Chinese medicine syndrome differentiation criteria of coronary heart disease[J]. Zhong Xi Yi Jie He Za Zhi, 1991,11(5):257
中国中西医结合学会心血管学会. 冠心病中医辨证标准[J]. 中西医结合杂志, 1991,11(5):257
[8] Zheng XY. Guidelines for clinical research on Chinese new herbal medicines(trial implementation)[M]. Beijing: China Medical Science Press, 2002: 72-73
郑莜萸 . 中药新药临床研究指导原则[M]. 北京: 中国医药科技出版社, 2002: 72-73
[9] Cardiology Branch of Chinese Medical Association, Editor Committee of Chinese Journal of Cardiology. Guidelines for the diagnosis and management of chronic stable angina[J]. Zhonghua Xin Xue Guan Bing Za Zhi, 2007,35(3):195-206
doi: 10.3760/j.issn:0253-3758.2007.03.002
中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 慢性稳定性心绞痛诊断与治疗指南[J]. 中华心血管病杂志, 2007,35(3):195-206
doi: 10.3760/j.issn:0253-3758.2007.03.002
[10] Cardiology Branch of Chinese Medical Association, Editor Committee of Chinese Journal of Cardiology. Guidelines for the diagnosis and management of unstable angina and non-ST-segment elevation myocardial infarction[J]. Zhonghua Xin Xue Guan Bing Za Zhi, 2007,35(4):295-304
中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 不稳定性心绞痛和非ST段抬高心肌梗死诊断与治疗指南[J]. 中华心血管病杂志, 2007,35(4):295-304
[11] Cardiology Branch of Chinese Medical Association, Editor Committee of Chinese Journal of Cardiology. Guidelines for the diagnosis and management of acute ST-segment elevation myocardial infarction[J]. Zhonghua Xin Xue Guan Bing Za Zhi, 2010,38(8):675-690
中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 急性ST段抬高型心肌梗死诊断和治疗指南[J]. 中华心血管病杂志, 2010,38(8):675-690
[12] Cardiology Branch of Chinese Medical Association, Editor Committee of Chinese Journal of Cardiology. Guidelines for the diagnosis and management of chronic heart failure[J]. Zhonghua Xin Xue Guan Bing Za Zhi, 2007,35(12):1076-1095
doi: 10.3760/j.issn:0253-3758.2007.12.002
中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 慢性心力衰竭诊断治疗指南[J]. 中华心血管病杂志, 2007,35(12):1076-1095
doi: 10.3760/j.issn:0253-3758.2007.12.002
[13] The Second Chinese Heart Failure Forum. Chinese expert consensus on diagnosis and treatment for heart failure with normal left ventricular ejection fraction[J]. Zhongguo Yi Kan, 2010,45(11):63-67
第二届中国心力衰竭论坛. 射血分数正常心力衰竭诊治的中国专家共识[J]. 中国医刊, 2010,45(11):63-67
[14] Wang JL. Clinical epidemiology: design, measurement and evaluation in clinical study.3rd ed[M]. Shanghai: Shanghai Scientific and Technical Publishers, 2009: 177
王家良 . 临床流行病学——临床科研设计、测量与评价.第3版[M]. 上海: 上海科学技术出版社, 2009: 177
[15] Xu H, Chen KJ, Shi DZ, Ma XC, Lü SZ, Mao JM . Clinical study of Xiongshao capsule in preventing restenosis after coronary interventional treatment[J]. Chin J Integr Med, 2002,8(3):162-166
[16] Zhang ZM, Gao YX, Liu HL, Yuan YQ, Yu L . Wentongjian in preventing coronary restenosis of percutaneous coronary intervention[J]. Zhongguo Dong Mai Ying Hua Za Zhi, 2006,14(7):610-612
doi: 10.3969/j.issn.1007-3949.2006.07.016
张志民, 高艳霞, 刘怀霖, 袁义强, 于力 . 温通煎能预防冠心病患者介入治疗后再狭窄[J]. 中国动脉硬化杂志, 2006,14(7):610-612
doi: 10.3969/j.issn.1007-3949.2006.07.016
[17] Li Y . Effects of puerarin on nailfold microcirculation and hemorheology in patients with coronary artery disease[J]. Zhongguo Wei Xun Huan, 1999,3(4):258
李勇 . 葛根素对冠心病患者甲襞微循环及血液流变学的影响[J]. 中国微循环, 1999,3(4):258
[18] Xu HH . Influence of Tongxinluo Capsule on nailfold microcirculation in patients with unstable angina pectoris[J]. Zhongguo Zhong Yi Ji Chu Yi Xue Za Zhi, 2003,9(3):41-42
徐鸿华 . 通心络胶囊改善不稳定型心绞痛患者甲襞微循环的观察[J]. 中国中医基础医学杂志, 2003,9(3):41-42
[19] Huang YS, Wang SR, Zhi YF, Kong SY, Sun L, Wu Y, Lu JM, Dai FM . Effects of Xuezhikang capsules on vascular endothelial function and redox status in patients with coronary artery disease[J]. J Chin Integr Med, 2006,4(3):251-255
黄彦生, 王树人, 智艳芳, 孔沈燕, 孙琳, 吴彧, 卢建敏, 戴付敏 . 血脂康胶囊对冠心病患者血管内皮功能及氧化还原态的影响[J]. 中西医结合学报, 2006,4(3):251-255
[20] Yang XH, Li MJ, Wang YL . Effects of Tongxinluo on inflammation and endothelial function in patients with coronary artery disease after coronary interventional treatment[J]. Shandong Yi Yao, 2008,48(41):78-80
杨新红, 黎明江, 王跃龄 . 通心络对冠心病患者介入术后炎症反应和血管内皮功能的调节作用[J]. 山东医药, 2008,48(41):78-80
[21] Zhao YX, Liu YF, Liu Y, Yan FF, Yu HM . Stabilizing effect of Quyu Xiaoban capsule on vulnerable plaque[J]. Zhong Yi Za Zhi, 2006,47(11):856-858
赵玉霞, 刘运芳, 刘艳, 燕芳芳, 于会明 . 祛瘀消斑胶囊对易损斑块的稳定作用[J]. 中医杂志, 2006,47(11):856-858
[22] Zhang BT, Yan QL, Yan DX, Li Z, Yu YC, Huang GP, Tang DS, Ye X . Molecular mechanism of effect of Wenban Humai granule on stability of atheromatous plaque[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2005,25(2):154-159
doi: 10.7661/CJIM.2005.2.154
张保亭, 颜乾麟, 颜德馨, 李智, 于永春, 黄国平, 汤德生, 叶新 . 稳斑护脉颗粒对动脉粥样硬化斑块稳定性影响的分子机制[J]. 中国中西医结合杂志, 2005,25(2):154-159
doi: 10.7661/CJIM.2005.2.154
[23] Dai RH, Li Y . Therapeutic angiogenesis in myocardial ischemia due to coronary artery disease and traditional Chinese medicine[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2000,20(3):163-164
戴瑞鸿, 李勇 . 冠心病心肌缺血的治疗性血管生成与中医药[J]. 中国中西医结合杂志, 2000,20(3):163-164
[24] Lei Y, Gao Q, Li YS, Chen KJ . Study on effects of Astragalus, Angelica and their combination on vascular endothelial cell proliferation in vitro[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2003,23(10):753-756
雷燕, 高倩, 李悦山, 陈可冀 . 黄芪、当归及其组方促血管内皮细胞增殖作用的研究[J]. 中国中西医结合杂志, 2003,23(10):753-756
[25] Jiang W, Ruan XM, Lin Y, Hu JX, Zhang MZ, Chen QX, Wu HL, Lin DQ, Chen XW, Huang CL, Deng TT . Clinical observation of “Shenmai Powder” in improving survival quality of patient undergoing coronary artery bypass grafting[J]. Shanghai Zhong Yi Yao Za Zhi, 2005,39(9):3-6
江巍, 阮新民, 林宇, 胡佳心, 张敏州, 陈秋雄, 吴焕林, 林冬群, 陈晓伟, 黄春林, 邓铁涛 . 生脉散对冠心病冠脉搭桥术后患者生存质量改善作用的临床观察[J]. 上海中医药杂志, 2005,39(9):3-6
[26] Mao JY, Bi YF, Wang HH, Wang XL, Chen DQ, Zhang BL . Study on clinical therapeutic effect of acute coronary syndrome patients treated in the unit integrated TCM and Western medicine[J]. Beijing Zhong Yi Yao, 2010,29(1):10-13
毛静远, 毕颖斐, 王恒和, 王贤良, 陈大权, 张伯礼 . 急性冠脉综合征中西医结合单元疗法临床疗效的评价[J]. 北京中医药, 2010,29(1):10-13
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