| 1.OverviewThis study is divided into four parts:literature review,cross-sectional study,meta-analysis and randomized controlled trial.The first part first clarifies the interaction mechanism and the latest research progress of gut microbiota and coronary heart disease(CHD),and then discusses the understanding of traditional medicine on coronary heart disease and the research progress of prevention and treatment of coronary heart disease by the theory of the Cardiosplenic Concurrent Treatment(CSCT).The second part is to observe the syndrome of qi deficiency and blood stasis,the structure and diversity of gut microbiota in CHD patients at different clinical stages in three groups of atherosclerosis,stable angina pectoris and non-ST-segment elevation acute coronary syndrome.The third part is a meta-analysis to objectively evaluate the clinical efficacy and safety of traditional Chinese medicine for treating the symptoms of CHD patients in different stages,and then further provide evidence-based basis for the clinical application of traditional Chinese medicine for treating the heart and spleen together.The fourth part is to evaluate the efficacy and safety of Xinpi Tongzhi Prescription in the treatment of acute non-ST segment elevation acute coronary syndrome(NSTE-ACS)of qi-deficiency and blood-stasis type through a randomized controlled trial,and provide clinical evidence support for Xinpi Tongzhi Prescription in the treatment of CHD patients at acute stages.2.Cross-sectional study:Correlation analysis of qi deficiency and blood stasis syndrome and gut microbiota characteristics in patients with coronary heart disease at different clinical stagesObjective The aim is to study the characteristics of gut microbiota in patients with CHD at different stages through fecal macrogenome analysis.Methods Through a single-center observational study,14 patients with atherosclerosis(As),15 patients with stable angina pectoris(SA),13 patients with unstable angina pectoris(UA),and 2 patients with acute non-ST-segment elevation myocardial infarction(NSTEMI)were included.DNA was extracted from the fecal samples of the subjects,and the structure and abundance of gut microbiota,as well as the alpha diversity(intra-group difference)and beta diversity(inter-group difference)of subjects’gut microbiota were analyzed.Results 1.The severity of CHD at different stages was positively correlated with the score of qi deficiency and blood stasis syndrome.2.Compared with As patients,the abundance of Chlamydomonas and Bacteroides in the gut microbiota of confirmed CHD patients decreased,while the abundance of Actinomyces and Verruciformes increased.At the same time,there are significant differences in the diversity of gut microbiota in CHD patients at different stages.The diversity of gut microbiota in UA and NSTEMI patients is higher than that in SA patients.Conclusion The degree of CHD is significantly related to the syndrome of qi deficiency and blood stasis.There are also obvious differences in the structure,abundance and diversity of gut microbiota in patients with CHD of qi deficiency and blood stasis at different stages.The progress of CHD intensely interacts with gut microbiota.3.Meta analysis:Meta-analysis of the effect of traditional Chinese medicine on improving CHD symptoms in different periodsObjective Through Meta-analysis to explore the clinical effectiveness of traditional Chinese medicine(TCM)with the Cardiosplenic Concurrent Treatment(CSCT)in improving the symptoms of patients with CHD of qi deficiency and blood stasis at different stages,and further provide evidence-based medical basis for the prevention and treatment of CHD using the CSCT.Methods Three Chinese and English databases were searched by computer:China Journal Full-text Database(CNKI),Wanfang Database(Wanfang),Chinese Science and Technology Journal Database(VIP),Pubmed Database,EMbase Database and Cochrane Library Database.The literature was screened according to the pre-set inclusion and exclusion criteria,and the quality of the randomized controlled trial(RCT)was evaluated using the Cochrane bias risk assessment tool,and the data was analyzed using the RevMan5.4 software.Results A total of 510 articles were retrieved,and 29 RCTs were finally included,which were divided into three parts:stable coronary heart disease,unstable angina pectoris and acute myocardial infarction,with a total of 4345 subjects.Meta analysis results:(1)CSCT is significantly superior to western medicine alone in improving the symptoms,electrocardiogram,left ventricular ejection fraction and other effective rates of patients with stable CHD(asymptomatic myocardial ischemia,stable angina pectoris);(2)CSCT is superior to western medicine alone in improving the clinical symptoms,electrocardiogram,left ventricular ejection fraction,and coronary artery stenosis of patients with unstable angina pectoris;(3)The effect of traditional Chinese medicine combined with conventional western medicine in improving the symptoms,myocardial enzymes,left ventricular ejection fraction and other effective rates in the acute phase of CHD(patients with acute myocardial infarction)is better than that of western medicine alone;(4)Safety analysis:Compared with conventional western medicine alone,CSCT has no significant difference in adverse reactions such as liver and kidney function and digestive system.Conclusion The analysis of this study shows that CSCT can significantly improve the symptoms of angina pectoris and cardiac function of CHD patients of qi deficiency and blood stasis at different stages,and also has a good security.However,the quality of the included literature still needs to be improved.The results of this meta-analysis still have some limitations,and more double-blind randomized controlled clinical trials with larger samples are still needed to further improve the reliability of the evidence.4.Randomized controlled study:Analysis of the therapeutic effect of heart-peen Tongzhi decoction on non-ST-segment elevation acute coronary syndrome of qi deficiency and blood stasis typeObjective To evaluate the efficacy and safety of Xinpi Tongzhi Prescription in treating NSTE-ACS patients of qi deficiency and blood stasis type.Methods 66 patients with NSTE-ACS of qi deficiency and blood stasis type were randomly divided into the test group(n=33)and the control group(n=33).The test group was treated with Xinpi Tongzhi Prescription combined with conventional western medicine orally,while the control group was treated with placebo combined with conventional western medicine orally for 14 days.The main efficacy index is the clinical effective rate(the degree of improvement of clinical symptoms),and the secondary index is the change value of the syndrome score of qi deficiency and blood stasis in traditional Chinese medicine and the score of the Seattle Angina Pectoris Scale(SAQ)from the baseline level to 14 days after treatment.At the same time,the subjective feelings of adverse reactions were recorded.SPSS 21.0 software was used for statistical analysis of the study.The measurement data were expressed in mean±standard deviation.T test was used for normal distribution,and rank sum test was used for non-normal distribution;The grade data is expressed by frequency,and the chi-square test is used.It is specified that P≤0.05 is statistically significant.Results 1.Basic situation analysis:The study subjects were 45 patients with NSTE-ACS who were hospitalized in Xiyuan Hospital of the Chinese Academy of Traditional Chinese Medicine(n=26),the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine(n=30),f the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine(n=10)from December 2020 to February 2023.They were randomly assigned to 33 patients in the same treatment group of Xinpi Tongzhi Prescription and 33 patients in the placebo group by random number table method,including 1 case in the same treatment group of Xinpi Tongzhi Prescription,with the dropout rate of 3.03%.There was no significant difference between the two groups in terms of age,gender and nationality(P>0.05),and the heterogeneity was small.2.Efficacy analysis:(1)The effective rate of angina pectoris symptoms:the overall effective rate of the test group was 93.94%(n=31)and that of the control group was 69.70%(n=23)after 14 days of medication,with statistically significant difference;(2)The effective rate of defecation:the overall effective rate of the test group was 69.70%(n=23)and that of the control group was 36.36%(n=12)after 14 days of administration,with a statistically significant difference;(3)The curative effect of qi-deficiency and blood-stasis syndrome in traditional Chinese medicine:the baseline score of qi deficiency and blood stasis syndrome in the test group was 6.64±2.57 points,and the score was 4.18±2.10 points 14 days after taking the medicine;The baseline score in the control group was 5.91 ± 2.92 points,and the score was 3.58±2.32 points 14 days after taking medicine;(4)The efficacy of the SAQ:analyzed from 5 dimensions,there was no significant difference between the two groups in terms of physical activity limitation,stable state of angina pectoris,attack of angina pectoris,treatment satisfaction,disease cognition score from the baseline level to the efficacy after 14 days of medication(P>0.05);(5)Safety:from the baseline level to the 14th day of treatment,there was no obvious abnormality in blood routine,urine routine,stool routine,liver and kidney function of subjects in both groups.The incidence of adverse reactions in the test group was 3.03%,and that in the control group was 0%.The adverse reactions were manifested by gastrointestinal symptoms such as abdominal distension and nausea.The symptoms disappeared automatically after stopping the drug by herself.Conclusions Xinpi Tongzhi Prescription combined with conventional western medicine is superior to placebo combined with conventional western medicine in improving the clinical symptoms and efficacy of patients with NSTE-ACS of qi deficiency and blood stasis type,scoring of syndrome of qi deficiency and blood stasis in traditional Chinese medicine,defecation and other aspects,and also can effectively improve the short-term prognosis of patients with better safety. |
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