| Background:There are a large number of CHD patients in the world,which is roughly estimated to be 110 million people.UAP is a common clinical type of CHD.Failure of timely intervention can lead to a high risk of myocardial infarction and endanger the life safety of patients.For the time being,the main treatment methods of UAP are PCI and drug therapy,but both methods have side effects,which affect the quality of life of patients.And carry on cardiac rehabilitation as early as possible,be helpful for the patient to alleviate symptom,improve life quality.Chinese medicine has a relatively perfect theoretical system for this disease,most of which believe that the pathogenesis of this disease is "Insufficiency of Yang and endogenous excess of Yin pathogens",and the method of warm medicinals to tonify Yang and promoting blood circulation to remove the blood stasis,is widely used in clinical practice.Acupoint application is a kind of cardiac rehabilitation with the characteristics of traditional Chinese medicine.By stimulating specific acupoints and absorbing drugs through the skin,acupoint application plays the role of health care and treatment of diseases,and avoids the effects of drugs on the gastrointestinal tract,liver and kidney while maintaining the efficacy,which has incomparable advantages over other drug therapies.Acupoint application is a kind of cardiac rehabilitation with TCM characteristics.It plays a role in health care and treatment of diseases by stimulating specific acupoints and transdermal absorption of drugs,and avoids the gastrointestinal reactions caused by drugs and the effects of liver and kidney functions while maintaining the efficacy.It has incomparable advantages over other drug therapies.Based on the traditional Chinese medicine theory of "Preventing disease from exacerbating",this trial used Fuyang acupoint application as an adjunct treatment for UAP,and observed the clinical efficacy.At the same time,it is also a beneficial exploration to make full use of the advantages of traditional Chinese medicine and establish a set of TCM with Chinese characteristics to participate in cardiac rehabilitationObjective:In this study,on the basis of conventional western medicine treatment,Fuyang acupoint application was applied to observe the clinical efficacy of acupoint application on UAP patients.Besides,the improvement of cardiac function,angina pectoris grade and self-assessment scale score of patients were observed after treatment.Safety evaluation was conducted after the end of the trial.Providing ideas for the cardiac rehabilitation of unstable angina pectoris of coronary heart disease.Method:A randomized,non-blinded,conventional treatment program-controlled trial design was adopted,and random numbers were generated by a computer random number generator.80 subjects who met the inclusion criteria were randomly divided into two groups,including 40 in the experimental group and 40 in the control group.Gender,age,blood pressure,heart rate and other information were recorded.The control group was treated with conventional Western medicine,mainly including antiplatelet therapy,reducing myocardial oxygen consumption,controlling blood pressure,lowering blood lipids,controlling blood glucose and symptomatic supportive treatment.The experimental group was treated with Fuyang acupoint application on the basis of the control group.Drug composition:aconite 30g,dried ginger 15g,cinnamon 15g,Cistanche 15g,bomeol 1g;selected acupoints:bilateral Xinshu acupoint,bilateral Neiguan acupoint,Danzhong acupoint,applied once every other day,retained for 3 hours each time,the course of treatment was 2 months.The clinical symptoms of the patients were recorded before and after treatment,and the scales such as the Quantitative Table of TCM Syndromes,SAQ,TCM-SCL-36 questionnaire were evaluated.The total effective rate and integral improvement rate of the treatment were calculated according to the Quantitative Table of TCM Syndromes.The angina pectoris score(CCS grade)was evaluated,and echocardiography was performed before and after treatment.The left ventricular mass(LVM),left ventricular ejection fraction(LVEF%),E/A were used as cardiac function evaluation indicators;the routine blood test,urine routine test,stool routine+occult blood test and liver and kidney function were used as safety evaluation indicators.After the end of the trial,the data were summarized and statistically analyzed by SPSS25.0,with P<0.05 as the statistical difference.Result:1.Baseline level comparison of subjects enrolled in the study:(1)there was no statistical difference between the two groups in demographic data(gender,age,blood pressure,heart rate);(2)there was no statistical difference between the two groups in coronary heart disease related scale scores(TCM syndrome scale score,SAQ score).There was no statistical difference in TSCL36 score(P>0.05);(3)there was no statistical difference in auxiliary examination indexes(electrocardiogram)(P>0.05);it was in line with the principle of randomized control,and the baseline data suggested that the two groups of patients had good comparability.2.According to the clinical effective standard set by the subject,25 of 40 patients in the experimental group of FAS were clinically effective,with an effective rate of 62.5%;17 of 40 patients in the control group were clinically effective,with an effective rate of 42.5%,and there was no statistical difference in the efficiency between the two groups(P>0.05);25 patients in the experimental group of PPS had an effective rate of 67.5%,and 17 patients in the control group had an effective rate of 44.7%.Statistical difference(P<0.05);FAS analysis results and PPS analysis results are inconsistent,may be affected by patient compliance,still need further study.3.Among the secondary outcome measures,(1)there was a statistical difference between the two groups in terms of treatment satisfaction and disease awareness in terms of changes in the Seattle angina score before and after treatment,while there was no statistical difference in other symptoms.(2)The results of FAS and PPS were consistent in terms of cardiac function and structure(such as cardiac structure,systolic function,diastolic function),and there was no statistical difference.(3)In terms of changes of TCM five-organ health status score before and after treatment,as well as the satisfaction of heart system and kidney system,there was a statistical difference between FAS and PPS analysis results after treatment between the two groups;(4)In terms of angina classification,FAS and PPS analysis results were consistent,without statistical difference.4.Two patients with adverse reactions were found in the experimental group,and the incidence of adverse reactions was 5%in 40 patients in the experimental group,which was not statistically different from the control group(P=0.247).The safety evaluation indexes of the two groups of patients were in the normal range before and after enrollment,so it can be considered that fuyang acupoint application is relatively safe in the clinical treatment of patients with unstable angina pectoris.Conclusion:1.Cardiac rehabilitation for unstable angina patients by applying Fuyang acupoint application can help improve the clinical symptoms of patients.Its advantages are:(1)In terms of the symptoms of angina pectoris:fuyang acupoint application can improve the overall symptoms of patients and improve the patients’ satisfaction with treatment;(2)In terms of the five zang organs of traditional Chinese medicine,the improvement of cardiacsymptoms and renal symptoms is better than conventional treatment;(3)Patients have a deeper understanding of the disease,which is beneficial to strengthen the control of risk factors for coronary heart disease;2.Under the current medical conditions in China,it is safe and feasible to apply Fuyang acupoint application for cardiac rehabilitation for unstable angina patients with angina classⅠ-Ⅲ. |
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