| The general idea of this study is to analyze and extract the change characteristics and treatment rules of common TCM syndromes of the occurrence and development of coronary heart disease,and carry out multidimensional efficacy evaluation through t he change of indicators,and further observe the effect of the teacher’s empirical prescr iption-"Invigorating qi and promoting blood circulation prescription" in clinic.The ar ticle is divided into three parts,step by step:namely,the first part is the analysis of the characteristics of TCM syndromes of coronary heart disease;The second part is sy stematic evaluation and meta-analysis of complete randomized controlled studies on the treatment of QI deficiency and blood stasis syndrome of CHD based on the first part.The third part is to observe the therapeutic effect of Yiqi Huoxue prescription on rec urrent stable angina pectoris after PCI.1.Objectives1.1 Analyze the characteristics of TCM syndromes of CHD,understand the distribution of TCM syndromes,symptoms and syndromes,and extract the main pathological basis,pathogenesis,symptoms and syndromes of CHD.1.2 Based on the conclusions of study 1,the completely randomized controlled literature on the treatment of CORONARY heart disease with qi deficiency and blood stasis syndrome by integrated Traditional Chinese and Western medicine was systematically evaluated,and the methodological,bias,clinical characteristics and other information were summarized qualitatively.Quantitative synthetic analysis of outcome indicators,to evaluate the effectiveness and safety of traditional Chinese medicine in the treatment of coronary heart disease syndrome of qi deficiency and blood stasis.1.3 According to the characteristics of qi deficiency and blood stasis syndrome of coronary heart disease,the effect of "Yiqi huoxuoxu Prescription" on recurrent stable angina pectoris after PCI was observed,and the curative effect was evaluated from the aspects of TCM syndromes,quality of life(survival),angina attack frequency,activity restriction due to angina pectoris and laboratory indicators.2.Methods2.1 Analysis of syndrome characteristics of coronary heart disease:Chinese Academic Journal Full-text Database(CNKI),Chinese Scientific and Technological Journal Database(VIP),wanfang Data Resources were searched from 1995 to December 31,2021.The search term "coronary heart disease+angina pectoris+myocardial infarction+acute coronary syndrome" was used as the initial search term.In the obtained results,"syndrome differentiation+syndrome element+syndrome type+ syndrome" was used as the retrieval term for the second retrieval.On the basis of which,non-coronary heart disease and other literatures that did not meet the inclusion criteria were eliminated,and finally included literatures were determined for the study of distribution characteristics of TCM syndromes,symptoms and syndrome types of coronary heart disease.2.2 Meta analysis:The retrieval strategy was formulated,and the retrieval scope was CNKI,VIP,Wanfang Data Knowledge Service Platform,Pubmed,Embase and Web of Science database.The search period is from 1995 to December 31,2021.The target literature was screened and information extracted in strict accordance with the established inclusion criteria,and the screening and extraction were independently completed by two researchers.Cochrane was used to conduct bias risk assessment.Meta-analysis was performed on the outcome indicators.Heterogeneity test was performed on the statistics to be combined before meta-analysis.The effect was judged intuitively by forest map and the publication bias of symmetry evaluation of funnel plot was observed.If the heterogeneity is too large,subgroup analysis or sensitivity analysis is used to determine the possible source of heterogeneity.2.3 Clinical research:Patients with recurrent stable angina pectoris with qi-deficiency and blood-stasis syndrome treated in affiliated Hospital of our university from January 2019 to October 2021 after PCI were collected and divided into exposed group(yiqi huoxue Prescription plus or less combined with conventional Western medicine)and non-exposed group(western medicine alone)by cohort study method.After 3 months of treatment,the changes of angina attack frequency and activity limitation degree,TCM syndrome,quality of life(survival),laboratory examination and other indicators were compared between the two groups before and after treatment.Main observations:Including TCM syndrome Score Scale,SF-36 Quality of Life Score Scale,Chinese Cardiovascular Patients Quality of Life Score Scale(CQQC),Seattle Angina pectoris Scale(SAQ),fasting blood glucose(FPG),total cholesterol(TC),triglyceride(TG),high density lipoprotein(HDL-C),low density lipoprotein(LDL-C),and the same HCY,C-reactive protein(CRP),GHR index(FPG/HDL-C)in non-diabetic patients,TyG index(In[TG(mg/dL)X FPG(mg/DL)/2])in diabetic patients.To evaluate the effect of Yiqi Huoxue prescription on patients with recurrent stable angina pectoris after PCI.3.Results3.1 Analysis of syndrome characteristics of coronary heart disease:3.1.1 Classification of research data:a total of 3813 literatures were retrieved from three databases,including 743 from CNKI,1167 from Wanfang Database and 1903 from VIP database.According to retrieve all criteria and after eliminating duplicate documents,eventually into 231 references,as the research object of the article 43 with coronary heart disease angina,myocardial infarction,39,22,acute coronary syndrome(acs)coronary artery after interventional article 13,2 cases of coronary artery bypass surgery,7 cases of arrhythmia,the remaining 105 study object for coronary heart disease,clinical classification have been made.A total of 63 articles only classified syndrome elements,147 articles only reported syndrome types,40 articles reported syndrome elements and syndrome types,and 17 articles reported clinical symptoms and tongue and pulse conditions.3.1.2 A total of 77708 patients were included in the study.Among them,32540 cases mentioned syndrome elements,including 13 syndrome elements,5 deficiency syndrome elements,qi deficiency was the first(57.01%);There were 8 solid syndromes,of which blood stasis(50.71%)and phlegm turbidity(28.24%)accounted for the most.8902 cases mentioned symptoms,including 15 symptoms,chest tightness,chest pain,shortness of breath,palpitation,fatigue accounted for more than 10%.There were 6500 cases of tongue symptoms,including 12 kinds of tongue symptoms,including purple dark tongue(19.72%),greasy moss(17.83%),white moss(14.96%),petechiae ecchymosis(9.71%).In 7101 cases,there were 7 kinds of pulse changes,including astringent pulse(27.55%),slippage pulse(24.26%),dull vein(20.18%),chord pulse(11.81%),knot pulse(9.17%),etc.70443 cases of syndrome type were mentioned,including deficiency syndrome,positive syndrome and mixed deficiency and solid syndrome.The highest proportion were qi deficiency and blood stasis(18.72%),blood stasis(12.61%)and mutual obstruction of phlegm and blood stasis(11.77%).Visible,this group of data analysis showed that blood stasis is the main pathological changes of the disease development foundation,blood stasis and phlegm turbidity is the main pathological product of this disease pathological changes of qi deficiency and blood stasis is the main pathogenesis characteristics,chest tightness,chest pain,shortness of breath,palpitations,fatigue strength of god as the main symptoms,such as dark purple tongue,petechiae,ecchymoses,as the main characteristic of tongue changes,Astringent veins,smooth veins,heavy fine veins,chord veins and knot veins are the main characteristics of pulse changes,and qi deficiency and blood stasis syndrome is one of the main manifestations of this disease.3.2 Meta analysis:3.2.1 Systematic evaluation data:a total of 27 completely randomized controlled studies on TCM intervention in the treatment of QI deficiency and blood stasis syndrome of coronary heart disease were included,with a total sample size of 2780 cases,including 1394 cases in the experimental group and 1386 cases in the control group.The random sequence generation method was described in 27 studies,including 1 study using lottery method and the other 26 studies using random number table method.One study mentioned the random-allocation scheme hiding method as sealed envelope method,while the remaining studies did not mention allocation hiding.None of the 27 studies mentioned blindness;Data of 27 studies were completely recorded without loss;None of the 27 studies found the tendency of selective reporting and were considered as non-selective reporting.Shedding and elimination of cases were mentioned in 3 studies;One study described the process of sample size estimation,and the other 26 studies did not mention sample size estimation.No intentionality analysis was conducted in 27 studies;Inclusion and exclusion criteria were mentioned in 21 studies,only inclusion criteria was mentioned in 1 study,and only exclusion criteria was mentioned in 5 studies.All 27 studies described baseline comparisons between groups;Statistical methods were mentioned in 27 studies;Twenty-one studies described informed consent or through ethics.3.2.2 Usage of commonly used Traditional Chinese medicines:among the top ten drugs in the treatment of QI deficiency and blood stasis syndrome of CORONARY heart disease included in the study,the drugs accounting for more than 5%were salvia miltiorrhiza(22 times,14.97%),Astragalus membranacea(17 times,11.57%),and Dangshen(14 times,9.53%).Seven studies involved specific symptom improvement,with symptoms accounting for more than 10%:palpitations(6,15%),chest pain(6,15%),shortness of breath(5,12.5%),fatigue(5,12.5%),and chest tightness(5,12.5%).It can be seen that invigorating qi and promoting blood circulation are commonly used,indicating that invigorating Qi and promoting blood circulation is the main treatment principle.3.2.3 Results of systematic evaluation and Meta analysis on treatment of Qi Deficiency and blood Stasis syndrome:(1)Improvement of TCM syndromes:nine studies included a total of 966 subjects,including 487 in experimental group and 479 in control group,407 in experimental group and 264 in control group.Heterogeneity test I2=76%>50%,P<0.0001.After sensitivity analysis excluded 2 references,heterogeneity test I2=0%,P=0.55>0.1,combined effect size Z=6.47,test value P<0.00001,combined effect value RR=1.28,For[95%CI 1.19,1.38].Therefore,the improvement of TCM syndrome in experimental group is better than that in control group.(2)Efficacy of anti-angina pectoris:there were 1,957 subjects in 20 studies,including 980 in experimental group and 977 in control group,871 in experimental group and 702 in control group.Heterogeneity test I2=0%,P=0.51>0.1,combined effect size Z=8.55,test value P<0.00001,combined effect value RR=1.2,95%CI[1.15,1.25].Therefore,the therapeutic effect of the experimental group against angina pectoris is better than that of the control group.(3)Ecg improvement:a total of 1575 subjects were included in 16 studies,including 792 in experimental group and 783 in control group,834 in experimental group and 522 in control group.Heterogeneity test I2=69%>50%,P<0.0001.After sensitivity analysis excluded one reference,heterogeneity test I2=0%,P=0.49>0.1,combined effect size Z=7.15,test value P<0.00001,combined effect value RR=1.25,For[95%CI 1.18,1.33].Therefore,the ecg improvement of the experimental group is better than that of the control group.(4)Incidence of adverse cardiovascular events:The total sample size of the two studies was 136,including 68 in the experimental group and 68 in the control group.Adverse cardiovascular events occurred in 6 in the experimental group and 20 in the control group.Heterogeneity test I2=0%,P=0.37>0.1,Z=9.92,P<0.00001,RR=1.24.For[95%CI 1.19,1.29].Therefore,the safety of experimental group is better than that of control group.3.3 Clinical research:3.3.1 Improvement of TCM syndromes:The improvement of qi deficiency and blood stasis syndrome in the exposed group was better than that in the non-exposed group after treatment(QI deficiency P=0.000<0.001;Blood stasis P=0.000<0.001);The difference of qi deficiency and blood stasis syndrome scores in the exposed group was significantly greater than that in the non-exposed group before and after treatment,and there was a significant difference between the two groups before and after treatment(P=0.000<0.001).The overall improvement of qi-deficiency and blood-stasis syndrome in the exposed group was better than that in the non-exposed group(P=0.000<0.001).Therefore,the improvement of TCM syndrome in the exposed group was significantly better than that in the non-exposed group.3.3.2 Improvement of quality of life(survival):the improvement of quality of life(survival)after treatment in the exposed group was significantly different from that in the non-exposed group(CQQC:P=0.000<0.001;Sf-36:P=0.000<0.001);The difference of quality of life(survival)score before and after treatment in the exposed group was greater than that in the non-exposed group,and the difference between the two groups before and after treatment was tested again,showing statistical significance(CQQC:P=0.000<0.001;Sf-36:P=0.000<0.001).So the improvement in life(survival)in the exposed group was significantly better than that in the non-exposed group.3.3.3 Improvement of angina attack frequency:Chi-square test was performed on the angina attack frequency of patients in the exposed group and the non-exposed group after treatment,X2=106.373,P=0.000<0.001.Compared with the non-exposed group,the angina attack frequency of patients in the exposed group was lower after treatment.3.3.4 Improvement of activity limitation due to angina pectoris:there were significant differences in the improvement of activity limitation due to angina pectoris after treatment between the two groups,all P values were less than 0.05(P=0.000<0.001;Indoor walking P=0.011<0.05;Bath P=0.000<0.001;P=0.000<0.001;Outdoor activities/sundry lifting P=0.000<0.001;Brisk walking 1 km P=0.000<0.001;Jogging 1 km P=0.000<0.001;Lifting or moving heavy objects P=0.000<0.001;Strenuous exercise,P=0.000<0.001).Therefore,the improvement of angina activity restriction in the exposed group was significantly better than that in the non-exposed group.3.3.5 Improvement of laboratory indicators:Before and after treatment,FPG,TG,HDL-C,LDL-C,CRP,GHR index(FPG/HDL-C)of non-diabetic patients and TyG index(LN[TG(mg/dL)× FPG(mg/DL)/2]of diabetic patients in the exposed group were significantly improved than those in the non-exposed group(FPG:P=0.043<0.05;TG:P=0.038<0.05;Hdl-c:P=0.042<0.05;Ldl-c:P=0.005<0.01;CRP:P=0.035<0.05;GHR index:P=0.012<0.05;TyG index:P=0.001<0.01),TC and HCY were significantly improved in both the exposed group and the non-exposed group before and after treatment,but there was no significant difference between the two groups after treatment.4.Conclusions4.1 Qi deficiency is the main pathological basis of the occurrence and development of this disease,blood stasis and phlegm are the main pathological products of this disease,qi deficiency and blood stasis are the main pathogenesis characteristics,and qi deficiency and blood stasis syndrome is the main symptom of this disease.Chest tightness,chest pain,shortness of breath,palpitation and fatigue were the main symptoms,purple and dark tongue and petechiae ecchymosis were the main characteristics of tongue image,and astringent pulse,smooth pulse,heavy fine pulse,chord pulse and nodal pulse were the main characteristics of tongue image.4.2 In the systematic evaluation of the complete randomized controlled study on the syndrome of qi deficiency and blood stasis in coronary heart disease,the representative Traditional Chinese medicine drugs for the treatment of the syndrome of Qi deficiency and blood stasis in coronary heart disease are mainly astragalus membranacea,Dangshen and Salvia miltiorrhiza.The symptoms of TCM treatment were palpitation,chest pain,shortness of breath,fatigue,chest tightness,etc.The improvement of TCM symptoms was consistent with the results of the first part of the analysis.It shows that invigorating qi and activating blood circulation is the main treatment principle.4.3 Meta-analysis of a completely randomized controlled study on the treatment of Coronary heart disease with Qi deficiency and blood stasis syndrome by Supplementing Qi and promoting blood Circulation With Traditional Chinese medicine combined with conventional Western medicine showed that the efficacy of the experimental group was better than the control group in the effective rate of anti-angina pectoris;The safety of the experimental group was better than the control group in the incidence of adverse cardiovascular events.There was a large heterogeneity between studies on TCM syndrome improvement and ecg efficacy,and sensitivity analysis showed that the efficacy of the experimental group was better than that of the control group after eliminating the source of heterogeneity.4.4 Yiqi huoxue prescription combined with conventional Western medicine treatment significantly improved the main symptoms,TCM syndrome,life(survival)quality and laboratory indicators of patients with stable angina pectoris after PCI,which was superior to conventional Western medicine treatment alone.4.5 The improvement of angina pectoris attack frequency and activity restriction caused by angina pectoris by yiqi huoxue prescription combined with conventional western medicine was significantly better than that by conventional Western medicine alone.5.The innovation points5.1 The overall research idea of the thesis and the progressive analysis of TCM syndrome characteristics and treatment drugs by Meta method have academic value.Based on clinical research literature,this study introduce the system evaluation analysis method,to extract the common characteristics of syndromes of coronary heart disease development and treatment situation,shows that qi deficiency and blood stasis are the main pathological changes of occurrence and development of coronary heart disease,blood stasis and phlegm turbidity is the main pathological product of the disease pathological changes,qi deficiency,blood stasis is the main pathogenesis characteristics,Qi deficiency and blood stasis syndrome is the main symptom of this disease,and the method of invigorating qi and promoting blood circulation is the main treatment principle.It is of great academic value to extract and reveal the characteristics and advantages of TRADITIONAL Chinese medicine to summarize and extract obj ective information of the disease through clinical data system.5.2 On the basis of multi-dimensional evaluation of qi deficiency and blood stasis syndrome and its treatment,it further confirmed the therapeutic advantage of Traditional Chinese medicine in the prognosis of coronary heart disease after PCI,which has application and promotion value.Based on the meta-analysis of TCM syndromes,angina pectoris,ecg improvement and adverse cardiovascular events in patients with coronary heart disease with qi deficiency and blood stasis,the therapeutic effect and commonly used drugs of invigorating qi and promoting blood circulation method were systematically evaluated.And on this basis,further clinical observation of the effects of "yiqi huoxue fang",its syndromes of PCI postoperative patients with angina pectoris,quality of life(survival),angina frequency,because of limited angina pectoris activity degree and the laboratory index,etc.,all have obvious therapeutic effect,show,or a combination of Chinese and western medicine of traditional Chinese medicine treatment of superiority,has the application and popularization value. |
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