Objective: To evaluate the effect and safety of Kuanxiong Aerosol (宽胸气雾剂, KA) on patients with angina pectoris. Methods: Block randomization was performed to randomly allocate 750 patients into KA (376 cases...Objective: To evaluate the effect and safety of Kuanxiong Aerosol (宽胸气雾剂, KA) on patients with angina pectoris. Methods: Block randomization was performed to randomly allocate 750 patients into KA (376 cases) and control groups (374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA (0.6 mL per spray). The control group received 1 sublingual nitroglycerin tablet (NT, 0.5 rag/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment (1,2, 3, 4, 5, and 〉5 min). Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society (CCS) classes of angina. Results: The 5-min remission rates in the KA and control groups were not significantly different (94.41% vs. 90.64%, P〉0.05). The angina CCS class significantly influenced the rate of remission (95% confidence interval = 0.483-0.740, P〈0.01). In the CCS subgroup analysis, the 3- and 5-min remission rates for KA and NT were similar in the CCS I and IV subgroups (P〉0.05), while they were significantly better for KA in the CCS Ⅱ and Ⅲ subgroups (P〈0.05 or P〈0.01). Furthermore, the inciden0ce of adverse reactions was significantly lower in the KA group than in the control group for the CCS Ⅱ and Ⅲ subgroups (9.29% vs. 26.22%, 10.13% vs. 20.88%, P〈0.05 or P〈0.01). Conclusions: KA is not inferior to NT in the remission of angina. Furthermore, in CCS Ⅱ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions. (Registration No. ChiCTR- IPR-15007204)展开更多
Objective: To investigate the distribution of Chinese medicine (CM) syndrome in patients with acute myocardial infarction (AMI) on admission and its impact on prognosis. Methods: A total of 525 AMI patients were prosp...Objective: To investigate the distribution of Chinese medicine (CM) syndrome in patients with acute myocardial infarction (AMI) on admission and its impact on prognosis. Methods: A total of 525 AMI patients were prospectively recruited and classified into 4 groups based on their clinical characteristics: excess-heat, excess-cold, deficiency-heat and deficiency-cold syndromes. Major adverse cardiovascular events (MACEs) were followed up. Results: The excess syndrome was more common than deficiency syndrome (72.95% vs. 27.05%;P<0.05). Totally 495 (94.29%) of 525 AMI patients were followed up (median 277 days). There were 59 (11.92%) MACEs. After adjusted with confounding factors in Cox regression models, the hazard ratio (95% confidence interval) of excess-heat, excess-cold, deficiency-heat and deficiency-cold syndrome groups were 1, 1.25 (0.63, 2.49;P<0.05), 2.37 (1.14, 4.94;P<0.05), 3.76 (1.71, 8.28;P<0.05), respectively. Conclusions: Excess syndrome was more common in AMI patients and had better prognosis, while deficiency-cold syndrome had the poorest prognosis. CM syndrome was of value in predicting long-term outcomes in AMI patients.展开更多
基金Supported by the Traditional Chinese Medicine Public Welfare Scientific Research Project,State Administration of Traditional Chinese Medicine of China(No.201007001)
文摘Objective: To evaluate the effect and safety of Kuanxiong Aerosol (宽胸气雾剂, KA) on patients with angina pectoris. Methods: Block randomization was performed to randomly allocate 750 patients into KA (376 cases) and control groups (374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA (0.6 mL per spray). The control group received 1 sublingual nitroglycerin tablet (NT, 0.5 rag/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment (1,2, 3, 4, 5, and 〉5 min). Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society (CCS) classes of angina. Results: The 5-min remission rates in the KA and control groups were not significantly different (94.41% vs. 90.64%, P〉0.05). The angina CCS class significantly influenced the rate of remission (95% confidence interval = 0.483-0.740, P〈0.01). In the CCS subgroup analysis, the 3- and 5-min remission rates for KA and NT were similar in the CCS I and IV subgroups (P〉0.05), while they were significantly better for KA in the CCS Ⅱ and Ⅲ subgroups (P〈0.05 or P〈0.01). Furthermore, the inciden0ce of adverse reactions was significantly lower in the KA group than in the control group for the CCS Ⅱ and Ⅲ subgroups (9.29% vs. 26.22%, 10.13% vs. 20.88%, P〈0.05 or P〈0.01). Conclusions: KA is not inferior to NT in the remission of angina. Furthermore, in CCS Ⅱ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions. (Registration No. ChiCTR- IPR-15007204)
基金Supported by the National Basic Research Program of China(No.2012CB518605)Science and Technology Innovative Program of Shanghai,China(No.10DZ1975400)
文摘Objective: To investigate the distribution of Chinese medicine (CM) syndrome in patients with acute myocardial infarction (AMI) on admission and its impact on prognosis. Methods: A total of 525 AMI patients were prospectively recruited and classified into 4 groups based on their clinical characteristics: excess-heat, excess-cold, deficiency-heat and deficiency-cold syndromes. Major adverse cardiovascular events (MACEs) were followed up. Results: The excess syndrome was more common than deficiency syndrome (72.95% vs. 27.05%;P<0.05). Totally 495 (94.29%) of 525 AMI patients were followed up (median 277 days). There were 59 (11.92%) MACEs. After adjusted with confounding factors in Cox regression models, the hazard ratio (95% confidence interval) of excess-heat, excess-cold, deficiency-heat and deficiency-cold syndrome groups were 1, 1.25 (0.63, 2.49;P<0.05), 2.37 (1.14, 4.94;P<0.05), 3.76 (1.71, 8.28;P<0.05), respectively. Conclusions: Excess syndrome was more common in AMI patients and had better prognosis, while deficiency-cold syndrome had the poorest prognosis. CM syndrome was of value in predicting long-term outcomes in AMI patients.