Objective:To observe the clinical effect and protection of vascular endothelium of Zhixin-kang Capsule (ZXKC) in middle-aged and old people with unstable effort angina and hyperlipidemia. Methods: Sixty-five patients ...Objective:To observe the clinical effect and protection of vascular endothelium of Zhixin-kang Capsule (ZXKC) in middle-aged and old people with unstable effort angina and hyperlipidemia. Methods: Sixty-five patients with unstable effort angina were randomly divided into ZXKC group (34 cases) and control group (31 cases). Conventional western medical therapy was given to both groups, with ZXKC group receiving additional ZXKC treatment. Data of 20 healthy persons were taken as normal group. Forty-eight patients with hyperlipidemia were divided into ZXKC group treated with ZXKC (31 cases) and control group treated with Yixintong (17 cases). The changes of clinical symptoms and laboratory indexes in all the patients were observed before and after treatment. Results: In patients with unstable effort angina, the efficacy of treatment of ZXKC, the withdrawal rate of nitroglycerin, the relieving of symptoms, the improvement of the electrocardiogram, the counts of circulating endothelial cells, the content of platelet P-selectin, the content of plasma endothelin (ET), the activity of superoxide dismutase (SOD) and the activity of malonyldialdehyde (MDA) were all better than those in the control group. In patients with hyperlipidemia, there was no significant difference in lipids reduction between ZXKC group and the control group. In both groups, the total cholesterol (TC), triglyceride (TG), low density lipo-protein-cholesterol (LDL-C), lipoprotein(a) [Lp(a)] , ET, oxidized low density lipoprotein, MDA, arte-riosclerotic index (AI) all lowered obviously, while the SOD, HDL-C and calcitonin gene-related peptide (CGRP) were all elevated markedly. In the ZXKC group, the nitric oxide(NO) increased significantly whereas the ET/CGRP and ET/NO decreased markedly. The total effective rate in symptom relieving, the markedly effective rate, the reduction of TC, ET and ET/CGRP, and the elevation of SOD in ZXKC group were all superior to those in the control group. Conclusion: ZXKC could effectively resist myocardial ischemia, relieve angina, reduce blood lipids, protect vascular endothelial cells, inhibit the activation of platelets, and resist lipid peroxidation.展开更多
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-bl...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 treatment group were similar with the control group, and the difference was not statistically significant （P〉0.05）. Couch=SlOB： In treatment of chronic stable angina （blood stasis syndrome）, WSC can reduce angina attacks and consumption of nitroglycerin, decrease angina severity degree, effectively relieve the blood stasis syndromes, such as chest pain, chest tightness, palpitations, dark purple tongue and other symptoms. Besides, adverse events and cardiovascular adverse events in the treatment group and the control group showed no difference. All shows that the drug is safe and effective. [This study was registered in Chinese Clinical Trial Registry （ChiCTR）, with registration number： ChiCTR-TRC-14005158.]展开更多
基金This study was funded by Natural Science Foundation of Shandong Province (No. Y97C22058)
文摘Objective:To observe the clinical effect and protection of vascular endothelium of Zhixin-kang Capsule (ZXKC) in middle-aged and old people with unstable effort angina and hyperlipidemia. Methods: Sixty-five patients with unstable effort angina were randomly divided into ZXKC group (34 cases) and control group (31 cases). Conventional western medical therapy was given to both groups, with ZXKC group receiving additional ZXKC treatment. Data of 20 healthy persons were taken as normal group. Forty-eight patients with hyperlipidemia were divided into ZXKC group treated with ZXKC (31 cases) and control group treated with Yixintong (17 cases). The changes of clinical symptoms and laboratory indexes in all the patients were observed before and after treatment. Results: In patients with unstable effort angina, the efficacy of treatment of ZXKC, the withdrawal rate of nitroglycerin, the relieving of symptoms, the improvement of the electrocardiogram, the counts of circulating endothelial cells, the content of platelet P-selectin, the content of plasma endothelin (ET), the activity of superoxide dismutase (SOD) and the activity of malonyldialdehyde (MDA) were all better than those in the control group. In patients with hyperlipidemia, there was no significant difference in lipids reduction between ZXKC group and the control group. In both groups, the total cholesterol (TC), triglyceride (TG), low density lipo-protein-cholesterol (LDL-C), lipoprotein(a) [Lp(a)] , ET, oxidized low density lipoprotein, MDA, arte-riosclerotic index (AI) all lowered obviously, while the SOD, HDL-C and calcitonin gene-related peptide (CGRP) were all elevated markedly. In the ZXKC group, the nitric oxide(NO) increased significantly whereas the ET/CGRP and ET/NO decreased markedly. The total effective rate in symptom relieving, the markedly effective rate, the reduction of TC, ET and ET/CGRP, and the elevation of SOD in ZXKC group were all superior to those in the control group. Conclusion: ZXKC could effectively resist myocardial ischemia, relieve angina, reduce blood lipids, protect vascular endothelial cells, inhibit the activation of platelets, and resist lipid peroxidation.
文摘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 treatment group were similar with the control group, and the difference was not statistically significant （P〉0.05）. Couch=SlOB： In treatment of chronic stable angina （blood stasis syndrome）, WSC can reduce angina attacks and consumption of nitroglycerin, decrease angina severity degree, effectively relieve the blood stasis syndromes, such as chest pain, chest tightness, palpitations, dark purple tongue and other symptoms. Besides, adverse events and cardiovascular adverse events in the treatment group and the control group showed no difference. All shows that the drug is safe and effective. [This study was registered in Chinese Clinical Trial Registry （ChiCTR）, with registration number： ChiCTR-TRC-14005158.]
