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 prognosis effect of Chinese herbal medicines(CHMs) for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome(ACS) ...Objective: To evaluate the prognosis effect of Chinese herbal medicines(CHMs) for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome(ACS) after percutaneous coronary intervention(PCI). Methods: A total of 702 patients with ACS who underwent PCI were enrolled and randomly assigned to receive conventional treatment plus CHMs for benefiting qi and activating blood circulation(treatment group, 351 cases) or conventional treatment alone(control group, 351 cases) for 6 months. Six months later, all patients received conventional treatment alone. Follow-ups were scheduled at 6th, 12 th, 18 th, 24 th month after enrollment in April 2008, and the final follow-up visit was during September 2011 and November 2011. The primary endpoint was the composite of cardiac death, nonfatal myocardial infarction or revascularization(PCI or coronary artery bypass grafting); and the secondary endpoint was the composite of re-admission for ACS, congestive heart failure, nonfatal stroke or other thrombus events. Results: A total of 621(88.59%) patients completed 35.4±3.8 months follow-up, while 80(11.41%) patients withdrew from the trial(41 in the treatment group and 39 in the control group). The incidence of primary endpoint was 5.7%(20 patients) in the treatment group versus 10.86%(38 patients) in the control group [relative risk(RR): 0.53; 95% confidence interval(CI): 0.30, 0.88; P=0.013; absolute risk reduction(ARR): –0.052, 95% CI: –0.06, 0.01]. The incidence of secondary endpoint was 5.98%(21 patients) in the treatment group versus 10.28%(36 patients) in control group(RR: 0.58, 95% CI: 0.33, 0.97, P=0.037; ARR: –0.043, 95% CI: 0.06, 0.01). Most of the primary and secondary endpoints were occurred in 18 months(84.50% in the treatment group versus 78.10% in the control group). Conclusion: CHMs for benefiting qi and activating blood circulation adjunctive to conventional treatment improved clinical outcomes for patients with ACS after PCI in long-term follow-up.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 Eleventh Five-Year Plan for Science and Technology Research of China(No.2006BA104A01)National Program on Key Basic Research Project of China(No.2015CB554402)
文摘Objective: To evaluate the prognosis effect of Chinese herbal medicines(CHMs) for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome(ACS) after percutaneous coronary intervention(PCI). Methods: A total of 702 patients with ACS who underwent PCI were enrolled and randomly assigned to receive conventional treatment plus CHMs for benefiting qi and activating blood circulation(treatment group, 351 cases) or conventional treatment alone(control group, 351 cases) for 6 months. Six months later, all patients received conventional treatment alone. Follow-ups were scheduled at 6th, 12 th, 18 th, 24 th month after enrollment in April 2008, and the final follow-up visit was during September 2011 and November 2011. The primary endpoint was the composite of cardiac death, nonfatal myocardial infarction or revascularization(PCI or coronary artery bypass grafting); and the secondary endpoint was the composite of re-admission for ACS, congestive heart failure, nonfatal stroke or other thrombus events. Results: A total of 621(88.59%) patients completed 35.4±3.8 months follow-up, while 80(11.41%) patients withdrew from the trial(41 in the treatment group and 39 in the control group). The incidence of primary endpoint was 5.7%(20 patients) in the treatment group versus 10.86%(38 patients) in the control group [relative risk(RR): 0.53; 95% confidence interval(CI): 0.30, 0.88; P=0.013; absolute risk reduction(ARR): –0.052, 95% CI: –0.06, 0.01]. The incidence of secondary endpoint was 5.98%(21 patients) in the treatment group versus 10.28%(36 patients) in control group(RR: 0.58, 95% CI: 0.33, 0.97, P=0.037; ARR: –0.043, 95% CI: 0.06, 0.01). Most of the primary and secondary endpoints were occurred in 18 months(84.50% in the treatment group versus 78.10% in the control group). Conclusion: CHMs for benefiting qi and activating blood circulation adjunctive to conventional treatment improved clinical outcomes for patients with ACS after PCI in long-term follow-up.