| Background:Coronary heart disease seriously endangers human health,and its clinical morbidity and mortality rank first among all diseases.Chronic stable coronary heart disease is the most common clinical type of coronary heart disease with a lots of people suffered,which has caused great pressure on cardiovascular disease prevention and control in China and even the whole world.Stable coronary heart disease always be kept in a stable state.The current secondary prevention of coronary heart disease has a positive effect on patients with stable coronary heart disease,but there are still some patients have a high risk of outcome,what is the reason?In the preliminary work of our research group,a large-scale multi-center randomized double-blind placebo-controlled clinical study of coronary heart disease based on the "blood stasis and toxin leading to events" theary created by academician KJ Chen was conducted.Compared with placebo,Qinxin Jieyu Granule combined modern therapy can reduce the incidence of one-year primary outcome in patients with stable coronary heart disease.In order to further clarify its effect on the long-term prognosis of this group of patients,our study was carried out.Objective:To observe the effect of Yiqi Huoxue Jiedu Decoction on the long-term prognosis of patients with stable coronary heart disease.Methods:Based on the previous research,916 patients with stable coronary heart disease were enrolled in 10 sub-central hospitals located in Beijing and Guangzhou and other cities in January 2013 to December 2017 for long-term follow-up.455 patients in the experimental group received Qingxin Jieyu granules combined with modern medicine treatment for 6 months,and 461 patients in the control group received the placebo of Qingxin Jieyu granules combined with modern medicine treatment for 6 months.The follow-up by telephone or by face-to-face was conducted in August 2019 to December 2019.The follow-up content includes:primary outcome include:cardiavascular death,non-fatal myocardial infarction,coronary revascularization;secondary outcome include:all-cause death,stroke,rehospitalization for ACS/malignant arrhythmia/heart failure,Other thrombotic complications;combined outcome include primary outcome and secondary outcome;composite outcome include:cardiavascular death,non-fatal myocardial infarction,and stroke.COX regression analysis was conducted by the different outcomes in different groups,and at the same time,gender,age,whether combined with the history of smoking,drinking,myocardial infarction,hypertension,hyperlipidemia,diabetes,stroke,peripheral atherosclerosis were included in the COX regression model for multivariate analysis.Results:The median follow-up time was 45 months,there were 14 patients(3.08%)in the experimental group with the primary outcome versus 29 events(6.29%)in the placebo group.The cumulative risk of primary outcome was 6.171%in the experimental group versus 10.438%in the placebo group.Compared with the placebo group,the experimental group can significantly reduce the occurrence of primary outcome(HR2.081,95%CI 1.100-3.938,P=0.024,log-rank test).However,the use of COX regression for multi-factor baseline adjustment did not show statistical significance(HR 1.862,95%CI 0.935-3.705,P=0.077);20 patients(4.01%)in the experimental group with the secondary outcome versus 27 patients(5.86%)in the placebo group,the ccumulative risk of outcome was 6.475%in the experimental group versus 8.382%in the placebo group,the experimental group was lower than the placebo group but shows no statistical significance(HR 1.352,95%CI 0.758-2.410,P=0.307,log-rank test),after COX regression for multi-factor baseline adjustment,the same conclusion was showed(HR 1.364,95%CI 0.731-2.545,P=0.329);a total of 26 patients(5.21%)in the experimental group had a combined outcome versus 45 patients(9.76%)in the placebo group.The cumulative risk of outcome is 8.162%in experimental group versus 15.146%in placebo group.Compared with the placebo group,the cumulative risk of combined outcome in experimental group was significantly reduced(HR 1.765,95%CI 1.089-2.861,P=0.021,log-rank test),after the adjustment by COX regression for multi-factor baseline,the same conclusion was showed(HR 1.746,95%CI 1.031-2.955,P=0.038);a total of 14 patients(2.81%)in the experimental group had a combined outcome versus 18 patients(3.90%)in the placebo group,cumulative risk of outcome was 7.331%versus placebo group 5.916%,it was lower but showed no statistical significance(HR 1.299,95%CI 0.646-2.613,P=0.462,log-rank test),after the adjustment of COX regression for multivariate baseline,the same conclusion was showed(HR 1.097,95%CI 0.495-2.431,P=0.819).Conclusion:Among patients with stable coronary artery disease,the combination of Qingxin Jieyu Granule to standard medical therapy can reduce the occurrence of the composite outcomes of cardiavascular death,nonfatal myocardial infarction,revascularization,all-cause death,stroke,rehospitalization for ACS or malignant arrhythmia or heart failure,and other thrombotic complications. |
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