| Objective:coronary heart disease(CHD)is one of the highest mortality diseases in the world.However,due to the serious and complicated coronary artery disease or the contraindications of surgical treatment,5%-10%of patients with coronary heart disease can not be treated with revascularization.In clinical treatment,such patients are usually referred to as coronary heart disease patients who are unable to reconstruct blood circulation.At present,the treatment of coronary heart disease in the clinical application of Western medicine alone can still be effective.However,the treatment of coronary heart disease with traditional Chinese medicine is also effective.Therefore,if the patients with severe coronary heart disease who can not reconstruct blood supply can use the treatment plan of traditional Chinese medicine combined with western medicine,they may achieve good results.In this study,the Chinese patent medicine of Shexiang Baoxin Pill and Western medicine were used to treat coronary heart disease of qi stagnation and blood stasis type,which could not be reconstructed in blood circulation.The effects on heart function,anti-inflammatory,symptom improvement,syndrome score improvement and prognosis were evaluated,and the safety of Shexiang Baoxin pill combined with western medicine was evaluatedMethods:from 2017 to 2019,80 outpatients and inpatients who met the inclusion criteria were selected from Guang'anmen Hospital of the Chinese Academy of traditional Chinese medicine.The innovation of this research is that the patients who meet the inclusion criteria of this study are randomly divided into two groups,the treatment group and the control group,each group has 40 cases.The treatment group was Shexiang Baoxin Pill+western medicine classic treatment group,and the control group was placebo+western medicine classic treatment group.The course of treatment was 6 months,and the changes of composite end point indexes(all-cause death,myocardial infarction,heart failure,incidence of moderate severe cardiovascular events of cerebral apoplexy),alternative end point indexes,TCM syndromes,safety indexes(vital signs,blood routine,biochemical items)and other relevant contents were observed and recorded before and after treatmentResult:1.The effect on the total ST segment decrease value,left ventricular ejection fraction and NT proBNP in each lead of ECG:after treatment,the total ST segment decrease value in each lead of ECG in the treatment group was 0.09 ± 0.14mv,lower than 0.42 ± 0.15mv in the control group,with significant difference between the two groups(P<0.01);after treatment,the left ventricular ejection fraction in the treatment group was 59.59 ± 8.70%,higher than 53.42 ± 6,34%in the control group,with significant difference between the two groups(P After treatment,NT proBNP in the treatment group was 105.82 ± 95.06 lower than that in the control group(185.01± 125.60),and there was significant difference between the two groups(P<0.01).The results showed that in improving heart function,Shexiang Baoxin Pill Combined with western medicine conventional treatment group was significantly better than placebo combined with western medicine conventional treatment group.2.Effect on C-reactive protein:after treatment,CRP in the treatment group was 4.18±3.26mg/l lower than 6.83 ± 5.37mg/l before treatment,and there was significant difference before and after treatment(P<0.01).The CRP of the control group was 4.66 ± 2.57mg/l after treatment,which was lower than 5.79 ± 3.57mg/l before and after treatment(P<0.05).There was no significant difference between the treatment group and the control group(P=0.495>0.05).The results showed that Shexiang Baoxin Pill Combined with western medicine conventional treatment group and placebo combined with western medicine conventional treatment group had anti-inflammatory effect,and the effect was similar3.To improve the clinical symptoms of chest distress,chest pain,asthenia and shortness of breath:after treatment,the scores of each item of Seattle angina pectoris scale in the two groups were compared,there was significant difference(P<0.05).The study shows that the combination of Shexiang Baoxin Pill and Western medicine is better than the combination of placebo and Western medicine in reducing clinical symptoms4.The effective rate of TCM syndrome:the total effective rate of the treatment group to improve TCM syndrome was 86.49%,the control group was 27.78%,there was significant difference between the two groups(P<0.01).The research shows that in improving TCM syndromes,Shexiang Baoxin Pill Combined with western medicine conventional treatment group is significantly better than placebo combined with western medicine conventional treatment group.5.The effect on the score of coronary artery disease:after treatment,the score of coronary artery disease was 23.27 ± 7.95 in the treatment group and 25.85 ± 11.24 in the control group.There was no significant difference between the two groups(P=0.264>0.05).The results showed that Shexiang Baoxin Pill Combined with western medicine conventional treatment group and placebo combined with western medicine conventional treatment group had no significant effect on reducing coronary lesions.6.The efficacy of composite endpoint(myocardial infarction,heart failure,all-cause death and other serious cardiovascular events):the incidence of composite endpoint was 24.32%in the treatment group and 47.22%in the control group,significantly lower in the treatment group than in the control group(P<0.05).The results showed that in the evaluation of composite endpoint,Shexiang Baoxin Pill Combined with western medicine conventional treatment group was significantly better than placebo combined with western medicine conventional treatment group.7.Clinical safety evaluation:during the treatment and follow-up,there was no significant difference between the two groups(P>0.05).The research shows that the safety of this project is high and there is no adverse reaction.Conclusion:on the basis of conventional western medicine treatment,the combination of Shexiang Baoxin Pill can effectively improve the heart function,anti-inflammatory,relieve clinical symptoms,significantly improve the syndrome score of traditional Chinese medicine in patients with coronary heart disease who can not reconstruct blood circulation of qi stagnation and blood stasis syndrome,and it is safe and reliable in clinical treatment for a long time. |
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