Protocol to study the effects of Traditional Chinese Medicine on pa-tients with coronary heart disease showing phlegm-heat-stasis symptom pattern

• 作者: BI Yingfei WANG Xianliang ZHANG Xuan HOU Yazhu ZHAO Zhiqiang REN Xiaoyu YANG Zhihua MAO Jingyuan
• 来源期刊: 中医杂志（英文版）
• 年，卷（期）: 2021,（5）
• 所属期刊栏目: Research Articles
• 页码范围: 826-832
• 页数: 7页
• 语种: 英文
• DOI: 10.19852/j.cnki.jtcm.2021.05.016

摘要

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.