| Coronary Heart Disease(CHD)is a heart disease caused by the narrowing or occlusion of the coronary arteries,resulting in ischemia,hypoxia,and even necrosis of cardiomyocytes.In recent years,the number of CHD patients has increased year by year,and the National Cardiovascular Disease Center released in 2022 that there are about 11.39 million CHD patients.The number of patients with this disease is large,easy to induce,acute and dangerous,which has seriously threatened human health.The traditional Chinese medicine divides CHD into various types,the current Qi-stagnation and blood-stasis type is one of the main syndrome types,and the corresponding treatment method is the method of regulating qi and activating blood circulation to remove blood stasis.In clinical practice,this disease is mainly treated with conventional western medicine,supplemented by traditional Chinese medicine.Clinical research literature on the curative effect of traditional Chinese medicine on CHD is not completely consistent,and the measurement standards are not uniform.Therefore,it is of great significance to explore the curative effect of regulating qi and activating blood circulation to remove blood stasis on the basis of Western medicine.In order to clarify the advantages of regulating Qi and activating blood circulation for removing blood stasis in the treatment of CHD,this study will demonstrate the efficacy and safety of regulating qi and activating blood circulation for removing blood stasis in the treatment of CHD by means of systematic review and meta-analysis.Systematic review refers to the rigorous evaluation and synthesis of all relevant studies on a given issue by using limiting bias strategies.As a link of quantitative systematic evaluation,meta-analysis can not only test the sources of differences between research results,but also quantitatively synthesize results with sufficient similarity to increase the reliability and authenticity of the research.Objective:To evaluate the efficacy and safety of regulating Qi and activating blood stasis in treating CHD with qi stagnation and blood stasis,and to provide reference for clinical decision-making and research.Methods:1.General information1.1 Determine the database and search time of the literature.According to the method of systematic evaluation,using China National Knowledge Infrastructure,CNKI,Wanfang Database,China Science and Technology Journal Database,VIP),China Biology Medicine disc(CBM disc),Pub Med,Cochrane Library,Embase database,search time from January 2000 to March 2022,To search the clinical trial literature about regulating Qi and activating blood stasis for treating coronary heart disease with qi stagnation and blood stasis.1.2 Formulate search strategies.Different databases use corresponding search methods,mainly according to the "PICOS" principle.It is necessary to manually retrieve the relevant literature information involved in the references to prevent omissions.1.3 Formulation of inclusion and exclusion criteria.Mainly according to the type of literature,study objects,intervention measures,efficacy indicators and so on.All the literatures included were clinical trial literatures.The subjects were all patients with qi-stagnation and blood-stasis.The intervention measures of the experimental group was regulating qi and promoting blood circulation and removing blood stasis combined with conventional western medicine,and the control group was conventional Western medicine.The traditional Chinese medicine dosage forms of regulating qi and promoting blood circulation for removing stasis are all decoction;in the included literature,there were two or more efficacy indicators for which data could be extracted.1.4 The therapeutic indexes were determined as TCM syndrome,angina pectoris,electrocardiogram and the rate of nitroglycerin withdrawal.2.Data processing and analysis2.1 Literature retrieval and screening were conducted according to inclusion and exclusion criteria.Literature was reviewed and screened by two independent researchers using Note Express software to include literature that met pre-established criteria.2.2 After literature inclusion,input tables were established and valid data were extracted.The effective data extracted included: author,paper title,publication time,literature type,grouping method,general information of patients(age,gender,number of patients),intervention measures,drug composition,administration method,drug dosage form,treatment time,adverse reactions,effective number of outcome indicators,etc.The prescriptions and high frequency drugs used in the method of regulating Qi and activating blood and removing blood stasis were selected,and the characteristics of high frequency drugs and the compatibility of prescriptions were expounded.2.3 The quality of the included literature was evaluated using the "bias risk assessment tool" recommended in the Cochrane Systematic Review Manual.It includes selection bias(random assignment method,assignment hiding scheme),implementation bias(blind implementation),measurement bias(blind evaluation),reporting bias(selective reporting),etc.2.4 Finally,the required data were imported into Rev Man5.4 software for meta-analysis,heterogeneity test,bias analysis and sensitivity analysis.The results of meta-analysis were represented by the forest map,suggesting which group had better efficacy than the experimental group and the control group;the funnel plot was used to indicate whether there was publication bias in the original literature.Heterogeneity test is represented by I~2,which can test whether there is heterogeneity or the degree of heterogeneity in the included original literature.Sensitivity analysis is used to measure the stability and reliability of meta-analysis results.2.5 Qualitative evaluation was carried out according to the statistical analysis results to evaluate the efficacy and safety of regulating Qi and activating blood stasis in the treatment of coronary heart disease with qi stagnation and blood stasis.Results:1.A total of 2112 literatures were retrieved from the Chinese and English databases,and 28 literatures were finally included after screening,with a total of 2024 patients,including 1015 cases in the experimental group and 1009 cases in the control group.2.There were a total of 22 Chinese prescription names using the method of regulating qi and promoting blood circulation and removing blood stasis,and 78 Chinese herbs were used in total.The top ten Chinese herbs used in literature were: Chuanxiong 22 times,licorice 22 times,Angelica 19 times,Salvia miltiorrhiza 18 times,Bupleurum 17 times,Fructus aurantii 15 times,safflower 15 times,red Peony 12 times,peach kernels 12 times,and Yanhu(Yuanhu)11 times.Among the high frequency drugs,8 kinds of drugs came from Xuefu Zhuyu decoction.3.There are certain selection,bias and implementation bias in the included clinical trial literature.4.Results of statistical analysis.4.1 Results of meta-analysis: 25 reported the curative effect of TCM syndrome,25 reported the curative effect of angina pectoris,26 reported the curative effect of electrocardiogram improvement,and 11 reported the rate of nitroglycerin withdrawal.The results of meta-analysis showed that: TCM syndrome curative effect[RR = 1.36,95% CI(1.30,1.43),Z = 11.91,P < 0.00001];Angina relief effect[RR = 1.35,95% CI(1.27,1.44),Z = 9.61,P < 0.00001];Electrocardiogram(ecg)to improve the curative effect[RR = 1.28,95% CI(1.20,1.35),Z = 7.94,P < 0.00001];Nitroglycerin stopped reduction rate[RR = 1.33,95% CI(1.22,1.46),Z = 6.28,P < 0.00001];The results of meta-analysis showed that RR(Relative Risk)values were all greater than 1,95%CI did not contain 1,and P values were all less than 0.05.The diamond shape representing the combined effect size in the forest map did not intersect with the invalid line,indicating that the difference between the two groups was statistically significant.The diamond shape in the four forest maps all fell on the side of the control group,suggesting that the overall efficacy of the experimental group was superior to the control group in the aspects of TCM syndrome,angina pectoris,electrocardiogram,and cessation rate of nitroglycerin.It showed that the combination of regulating qi and activating blood circulation and removing blood stasis had better effect than simple Western medicine.4.2 The I~2 values were all less than 50%,indicating that the heterogeneity of the included literatures was small.The funnel plots of the four outcome indicators are not completely symmetrical,which indicates that there may be some publication bias in the original literature.The results of sensitivity analysis showed that the combined effect size and 95%CI had no significant changes after excluding single studies,indicating that the results of meta-analysis were reliable and stable.5.Safety evaluation: A total of 1015 cases were included in the experimental group,with 9 cases of adverse reactions,and 1009 cases in the control group,with 18 cases of adverse reactions.By comparing the incidence of adverse reactions between the two groups,meta-analysis showed that: [RR=0.50.,95%CI(0.24,1.06),Z=1.80,P=0.07],95%CI crossed1,P > 0.05,combined effect size cross the invalid line,indicating no statistic al significance between the two groups.It suggested that there was no statistical significance in the incidence of adverse reactions of regulating Qi and promoting blood circulation and removing blood stasis combined with conventional western medicine compared with conventional Western medicine alone.The safety of regulating Qi and activating blood circulation and removing stasis combined with conventional Western medicine needs to be further analyzed after increasing the sample size and unifying the standard of adverse reactions.Conclusion:1.In terms of the four therapeutic indexes of TCM syndrome,ECG,angina pectoris and the stopping rate of nitroglycerin,regulating Qi and activating blood stasis combined with conventional western medicine has a better effect on coronary heart disease of Qi stagnation and blood stasis than conventional western medicine alone.2.There was no statistical difference in the incidence of adverse reactions between regulating Qi and activating blood circulation and removing blood stasis combined with conventional western medicine and simple conventional Western medicine.3.Due to the risk of bias in the existing original literature,more high-quality,large sample and multi-center randomized controlled clinical trials need to be supplemented and demonstrated in the future. |
PDF Full Text Request