Objectives:To evaluate the effectiveness and safety of Qishen Yiqi Dripping Pill(QSYQ)in patients with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI).Methods:This multicentre prospective coh...Objectives:To evaluate the effectiveness and safety of Qishen Yiqi Dripping Pill(QSYQ)in patients with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI).Methods:This multicentre prospective cohort study was conducted at 40 centers in China.Patients with ACS after PCI entered either the QSYQ or Western medicine(WM)groups naturally based on whether they had received QSYQ before enrollment.QSYQ group received QSYQ(0.52 g,3 times a day for 12 months)in addition to WM.The primary endpoint included cardiac death,non-fatal myocardial infarction,and urgent revascularization.The secondary endpoint included rehospitalization due to ACS,heart failure,stroke,and other thrombotic events.Quality of life was assessed by the Seattle Angina Questionnaire(SAQ).Results:A total of 936 patients completed follow-up of the primary endpoint from February 2012 to December 2018.Overall,487 patients received QSYQ and WM.During a median follow-up of 566 days(inter quartile range,IQR,517–602),the primary endpoint occurred in 46(9.45%)and 65(14.48%)patients in QSYQ and WM groups respectively[adjusted hazard ratio(HR)0.60,95%confidence interval(CI)0.41–0.90;P=0.013].The secondary endpoint occurred in 61(12.53%)and 74(16.48%)patients in QSYQ and WM groups,respectively(adjusted HR 0.76,95%CI 0.53–1.09;P=0.136).In sensitivity analysis,the results still demonstrated that WM combined with QSYQ reduced the risk of the primary endpoint(HR 0.67,95%CI 0.46–0.98;P=0.039).Moreover,QSYQ improved the disease perception domain of the SAQ(P<0.05).Conclusions:In patients with ACS after PCI,QSYQ combined with WM reduced the incidence of the primary endpoint.These findings provide a promising option for managing ACS after PCI and suggest the potential treatment for reducing the risk of primary endpoint included cardiac death,non-fatal myocardial infarction,and urgent revascularization through intermittent administration of QSYQ.(Registration No.Chi CTR-OOC-14005552).展开更多
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
Coronary artery disease(CAD)remains the leading cause of mortality worldwide.Despite advanced pharmacologic development and invasive revascularization therapy,a small but not insignificant number of patients show prog...Coronary artery disease(CAD)remains the leading cause of mortality worldwide.Despite advanced pharmacologic development and invasive revascularization therapy,a small but not insignificant number of patients show progression to end-stage CAD and no further invasive therapy option who have to wait for heart transplantation.展开更多
基金Supported by the Traditional Chinese Medicine Public Welfare Scientific Research Project,State Administration of Traditional Chinese Medicine of the People's Republic of China(No.201007001)Fundamental Research Funds for the Central Public Welfare Research Institutes(No.ZZ13-YQ-005 and No.ZZ13-YQ-005-C1)。
文摘Objectives:To evaluate the effectiveness and safety of Qishen Yiqi Dripping Pill(QSYQ)in patients with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI).Methods:This multicentre prospective cohort study was conducted at 40 centers in China.Patients with ACS after PCI entered either the QSYQ or Western medicine(WM)groups naturally based on whether they had received QSYQ before enrollment.QSYQ group received QSYQ(0.52 g,3 times a day for 12 months)in addition to WM.The primary endpoint included cardiac death,non-fatal myocardial infarction,and urgent revascularization.The secondary endpoint included rehospitalization due to ACS,heart failure,stroke,and other thrombotic events.Quality of life was assessed by the Seattle Angina Questionnaire(SAQ).Results:A total of 936 patients completed follow-up of the primary endpoint from February 2012 to December 2018.Overall,487 patients received QSYQ and WM.During a median follow-up of 566 days(inter quartile range,IQR,517–602),the primary endpoint occurred in 46(9.45%)and 65(14.48%)patients in QSYQ and WM groups respectively[adjusted hazard ratio(HR)0.60,95%confidence interval(CI)0.41–0.90;P=0.013].The secondary endpoint occurred in 61(12.53%)and 74(16.48%)patients in QSYQ and WM groups,respectively(adjusted HR 0.76,95%CI 0.53–1.09;P=0.136).In sensitivity analysis,the results still demonstrated that WM combined with QSYQ reduced the risk of the primary endpoint(HR 0.67,95%CI 0.46–0.98;P=0.039).Moreover,QSYQ improved the disease perception domain of the SAQ(P<0.05).Conclusions:In patients with ACS after PCI,QSYQ combined with WM reduced the incidence of the primary endpoint.These findings provide a promising option for managing ACS after PCI and suggest the potential treatment for reducing the risk of primary endpoint included cardiac death,non-fatal myocardial infarction,and urgent revascularization through intermittent administration of QSYQ.(Registration No.Chi CTR-OOC-14005552).
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 Natural Science Foundation of China(No.81603489)Fundamental Research Funds for the Central Public Welfare Research Institutes(No.ZZ13-YQ-005)+1 种基金Training Plans for Young Teachers of Xiyuan Hospital,China Academy of Chinese Medical SciencesNational Key Research Program(No.2019YFC1710303)。
文摘Coronary artery disease(CAD)remains the leading cause of mortality worldwide.Despite advanced pharmacologic development and invasive revascularization therapy,a small but not insignificant number of patients show progression to end-stage CAD and no further invasive therapy option who have to wait for heart transplantation.