【摘 要】
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OBJECTIVE:To describe a protocol to assess the ef-fects of Traditional Chinese Medicine (TCM) on pa-tients with coronary heart disease (CHD) showing symptoms of phlegm-heat-stasis symptom pattern.METHODS:This is a single-blind randomized con-trolled trial
【机 构】
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Department of Cardiology,the First Teaching Hospital of Tianjin University of Traditional Chinese Me
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OBJECTIVE:To describe a protocol to assess the ef-fects of Traditional Chinese Medicine (TCM) on pa-tients with coronary heart disease (CHD) showing symptoms of phlegm-heat-stasis symptom pattern.METHODS:This is a single-blind randomized con-trolled trial that will be conducted in the First Teach-ing Hospital of Tianjin University of TCM and 60 pa-tients with CHD showing phlegm-heat-stasis symp-tom pattern will be included.Patients will be ran-domly divided into either a treatment group (Qin-gre Huatan formulae + Western Medicine) or to a control group (conventional Western Medicine on-ly) for 7-14 d.Primary patient outcomes will be vas-cular endothelial function and quality of life.Mea-surement data will be expressed as mean ± stan-dard deviation using t-test analysis or repeat-ed-measure variance analysis.Enumeration data will be expressed by cases and percentages,using x2 analysis,and rank sum test will be used for ranked data.RESULTS:This study further verified the effective-ness and safety of Qingre Huatan formulae for the phlegm-heat-stasis syndrome pattern of CHD on the basis of previous studies on the characteristics of syndromes and medication rules.DISCUSSION:Phlegm-heat-stasis symptom pat-tern has become a common manifestation in CHD.Standardized Western medications together with TCM have been extensively used in China and have developed into a comprehensive treatment model.Our trial will help formulate recommendations for symptom maintenance and provide clinical evi-dence for the application of TCM for patients with CHD showing phlegm-heat-stasis symptom pattern.
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