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A Multicenter,Randomized,Double-blind Clinical Study on Wufuxinnaoqing Soft Capsule(五福心脑清胶囊) in Treatment of Chronic Stable Angina Patients with blood stasis syndrome

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chinese Journal of Integrative medicine 2015年第8期21卷 571-578页

作者：张智芳徐凤芹刘红旭王凤荣赵明君孙兰军许勇胡有志 Beijing University of chinese medicine Senior Cardre Department Xiyuan Hospital of China Academy of Chinese Medical Sciences Beijing Hospital of Traditional chinese medicine Affiliated Hospital of Liaoning University of Traditional chinese medicine Affiliated Hospital of Shaanxi chinese Medical College Second Affiliated Hospital of Tianjin University of Traditional chinese medicine Affiliated Hospital of Chengdu University of Traditional chinese medicine Hubei Provincial Hospital of Traditional chinese medicine

Objective： To confirm the efficacy and safety of Wufuxinnaoqing Soft Capsule （五福心脑清胶囊, WSC） in the treatment of chronic stable angina （blood stasis syndrome）. Methods： A multicenter, randomized, double-blind, placebo-controlled trial with superiority test was designed. A total of 240 patients with chronic stable angina （blood stasis syndrome） from multiple centers were randomly and equally assigned to the treatment group and the control group. Based on standard treatment of Western medicine, the treatment group was given WSC, while the control group was given WSC mimetic, both for 12 weeks. Observed indicators included the efficacy in angina, the efficacy in chinese medicine syndrome, the withdrawal or reduce rate of nitroglycerin and routine safety indices. Results： After 12-week treatment, the significant effective rate and total effective rate of the treatment group were significantly better than those of the control group （23.5% vs. 9.2%, 64.7% vs. 30.8%）, respectively, with statistically significant difference （P〈0.01）. After 12-week treatment, the decreased points and the decreased rate of angina symptom score in the treatment group were better than in the control group （5.1±4.2 points vs. 2.8± 3.5 points, 44.9% ±37.2% vs. 25.4%±30.7%） respectively, with significant difference （P〈0.01）. After 12-week treatment, the significant effective rate and total effective rate of the treatment group were better than the control group （respectively, 30.3% vs. 15.0%, 67.2% vs. 45.0%, P〈0.01）. After 8- or 12-week treatment, the decreased points and the decreased rate of chinese medicine syndrome score in the treatment group were better than the control group （P〈0.05 or P〈0.01）. After 12-week treatment, nitroglycerin withdrawal rate and the withdrawal or reduce rate in treatment group were better than the control group （P〈0.01）. On safety evaluation, the incidence of adverse events （7.563% vs. 7.500%） and the incidence of cardiovascular events （0.840% vs. 0.000%） in the trea

关键词： Wufuxinnaoqing Soft Capsule,chronic stable angina blood stasis syndrome,chinese medicine therapy

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