| Purpose:To observe the effect of Yiqi Liangxue Shengji Granules on in-stent restenosis,adverse cardiovascular events,TCM symptoms and physical signs,quality of life in patients with coronary heart disease after PCI.Methods:(1)From October 2015 to April 2017,patients who successfully performed stenting in the Department of Cardiology at the Dong Fang Hospital of Beijing University of Chinese Medicine were included in 120 cases.After the informed consent of the patients,the two groups were randomly divided into 58 cases of traditional Chinese medicine treatment group and 62 cases of Western medicine control group according to the randomized protocol and signing informed consent.(2)The selected cases were referred to the "Guide to Percutaneous Coronary Intervention in China(2016)" of the Chinese Medical Association.Both groups were treated with conventional western medicines.They included low molecular weight heparin,clopidogrel hydrogen sulfate,aspirin,statins,ACEI or ARB drugs,beta blockers,nitrates and other drugs from the day of surgery..The treatment group was given a supplement of Yiqi Liangxue Shengji formula granules on the basis of routine western medicine treatment and was subcutaneously treated with warm water twice a day.The course of treatment was 8 weeks after operation.(3)The main evaluation indicators were coronary angiography review,and observation of patients with endpoint events(cardiogenic death,recurrent angina,severe heart failure and the need for re-intervention or coronary artery bypass graft surgery)of follow-up patients in one year.The occurrence of the disease;secondary evaluation indicators for the postoperative day and 8 weeks after surgery,record and evaluate the two groups of patients with TCM symptoms and signs,angina points and Seattle Angina Scale.(4)When adverse reactions or research-related accidents are discovered,the researcher will take necessary measures to deal with the condition.All adverse events will be followed up until they are properly resolved or the condition is stable.(5)SPSS 20.0 statistical analysis software was used for data statistical analysis.Measured data of compliance and normal distribution were expressed as meanąstandard deviation.Measured data that did not obey normal distribution were expressed as median(interquartile range).For continuous data,a normal test is performed first.If the groups meet normality and the groups have equal variances,one-way analysis of variance is used for comparison between groups.Comparison between groups is performed using the LSD method;otherwise non-parametric Wilcoxon rank-sum tests are considered.For the categorical data,the chi-square test was used for the out-of-order results,and the non-parametric Wilcoxon rank-sum test was used for the ordered data.The multivariate analysis of the dependent variable was a binary variable.Using binary logistic regression analysis,p<0.05 indicated a statistical difference.Results:(1)General information:A total of 120 selected cases were successfully treated with coronary stenting,including 58 cases in the treatment group and 62 cases in the control group.After statistical analysis,there was no statistical difference(p>0.05)in age,sex,hypertension,dyslipidemia,diabetes,smoking,personality,number of diseased vessels,type of implanted stent or number of implanted stents,the result is comparable.(2)In-stent restenosis and estimated restenosis:A total of 64 patients underwent coronary angiography 1 year after surgery.Compared with the two groups,the in-stent restenosis rate in the treated group was 6.9%,and that in the control group was 14.3%.The difference was not statistically significant(p=0.299>0.05);Estimates of restenosis events combined with coronary angiography for in-stent restenosis and recurrence of angina.The restenosis rate was estimated to be 10.7%in the treatment group and 27.3%in the control group,the difference between the two groups was significant(p=0.023<0.05),with statistical significance.(3)Cardiovascular events:The occurrence of adverse cardiovascular events was followed up for 1 year after surgery.There were 9 cases lost to follow-up,and the number of follow-up cases was 111 cases.A single adverse cardiovascular event and a combined cardiovascular event were compared between the two groups of patients.After statistical tests,There was a statistically significant difference in the incidence of recurrent angina and combined cardiovascular events between the two groups,p<0.05.(4)Risk factors assessment:Logistic regression analysis was used to analyze the effects of gender,age,hypertension,diabetes,smoking,and other risk factors on the estimation of restenosis and combined adverse cardiovascular events.The results showed that intervention of traditional Chinese medicine was a protective factor for estimating restenosis and combined adverse cardiovascular events.(5)TCM symptoms and signs scores:There was no statistical difference between the two groups of TCM symptom scores before the intervention.After the intervention,the chest pain,chest tightness,shortness of breath,fatigue,palpitations,upsets,mouth pain,and choroid blood stasis were significantly lower in both groups than before treatment(p<0.05).The symptoms of shortness of breath,fatigue,and palpitations in the treatment group were significantly better than those in the control group(p<0.05).(6)Angina Symptom Score:Before intervention,there was no statistical difference in the scores of angina symptoms between the two groups.After intervention,the scores of angina symptoms in both groups were significantly lower than before treatment(p<0.05),but there was no significant difference between the two groups before and after intervention.(7)Seattle Angina Scale Integral:Before the intervention,there was no statistical difference in the scores of the two groups of Seattle angina.After the intervention,both Seattle angina scores were significantly higher than before treatment(p<0.05).but there was no significant difference between the two groups before and after intervention.Conclusion:(1)The use of Yiqi Liangxue Shengji granules after PCI for coronary heart disease has a tendency to reduce the incidence of in-stent restenosis,which can significantly reduce the incidence of estimated restenosis;it can significantly reduce the incidence of recurrent angina and combined adverse cardiovascular events;It can improve the symptoms and signs of patients in TCM.(2)Intervention with Yiqi Liangxuesheng Ji Granules after PCI is a protective factor for estimating restenosis events and combined adverse cardiovascular events. |
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