| 1 | Western medication plus Traditional Chinese Medicine preparations in patients with chronic heart failure:a prospective,single-blind,randomized,controlled,and multicenter clinical trial显示文摘OBJECTIVE: To assess the efficacy and safety in patients with chronic heart failure(CHF) of Western medication plus Traditional Chinese Medicine(TCM) preparations.METHODS: This prospective, single-blind, randomized, controlled, and multicenter clinical trial began on September 17, 2008, and was completed on June 25, 2011. A total of 340 inpatients, aged 40-79 years, with exacerbating CHF from 10 hospitals were enrolled and randomly allocated within 24 h of admission. The trial included three intervention periods. During hospitalization, the control group received western medication for CHF and the treatment group received Danhong injection with Shenfu injection or Shenmai injection. After discharge,all patients were treated with Qiliqiangxin capsules and Buyiqiangxin tablets or a placebo for 6 months. After the 6-month intervention, both groups received only continuous western medication. The primary endpoint was all-cause mortality.The efficacy assessments were as follows: B-type natriuretic peptide(BNP), Lee's HF score, the 6-minute walking test(6 MWT), left ventricular ejection fraction(LVEF), and the Minnesota Living with Heart Failure Questionnaire(MLHFQ). The safety assessments were as follows: blood and urine routine examination, hepatic and renal function, electrolytes in blood and adverse events.RESULTS: Compared with the control group, the treatment group showed a 30.99% reduction in all-cause mortality and an improved survival rate.The treatment group showed greater improvement in 6 MWT(P = 0.02) than the control group on discharge, after 12-month follow-up, there was a time-group interaction for MLHFQ(P = 0.03). Incidence rate of adverse events and other relevant safety indexes were not statistically significant between the two groups.CONCLUSION: Western medication plus TCM treatment can increase 6-minute walking distance(improve exercise tolerance) and quality of life with heart failure patients. | Wang Xianliang Hou Yazhu Mao Jingyuan Zhao Yingqiang Niu Tianfu Yuan Ruyu Wang Yonggang Cui Jin-rong Shi Le Jia Xiuli Fan Ruihong Lin Qian Zhang Yan Li Zhijun Shang Hongcai Wang Baohe Wang Hongwu Wang Henghe Cui Xiaolei Soh Shanbin Ruan Jishou Zhang Boli | 2017 | Journal of Traditional Chinese Medicine2017，37，6： | 15 |
| 2 | Protocol to study the effects of Traditional Chinese Medicine on patients with coronary heart disease showing phlegm-heat-stasis symptom pattern显示文摘OBJECTIVE:To describe a protocol to assess the effects of Traditional Chinese Medicine(TCM)on patients with coronary heart disease(CHD)showing symptoms of phlegm-heat-stasis symptom pattern.METHODS:This is a single-blind randomized controlled trial that will be conducted in the First Teaching Hospital of Tianjin University of TCM and 60 patients with CHD showing phlegm-heat-stasis symptom pattern will be included.Patients will be randomly divided into either a treatment group(Qingre Huatan formulae+Western Medicine)or to acontrol group(conventional Western Medicine only)for 7-14 d.Primary patient outcomes will be vascular endothelial function and quality of life.Measurement data will be expressed as mean±standard deviation using t-test analysis or repeated-measure variance analysis.Enumeration data will be expressed by cases and percentages,usingχ^(2) analysis,and rank sum test will be used for ranked data.RESULTS:This study further verified the effectiveness 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 pattern 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 evidence for the application of TCM for patients with CHD showing phlegm-heat-stasis symptom pattern. | BI Yingfei WANG Xianliang ZHANG Xuan HOU Yazhu ZHAO Zhiqiang REN Xiaoyu YANG Zhihua MAO Jingyuan | 2021 | Journal of Traditional Chinese Medicine2021，41，5： | 1 |
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