The Clinical Study Of Ruanjian Tongmai Decoction Combined With Baduanjin In The Second-stage Cardiac Rehabilitation After Coronary Heart Disease PCI

1 Objective1.1 The cross-sectional study:To evaluate the current cardiac rehabilitation(CR)state on patients of coronary heart disease(CHD)after PCI and analyze the possible causes,and to provide a basis for the clinical trial.1.2 The clinical trial:To observe the clinical effect of "ruanjian tongmai decoction" combined with Baduanjin,the comprehensive traditional Chinese medicine(TCM)interventions,on CHD patients after PCI in CR stage ?,and to preliminarily explore the possible mechanism from th e perspective of vascular endothelial function.2 Methods2.1 The cross-sectional study:We did a clinical epidemiological cross-sectional survey on CHD patients after PCI.From February 2017 to November 2018,patients were enrolled in Dongzhimen Hospital.First,we investigated their control of CHD risk factors,frequency of recurrent cardiovascular events and their quality of life(QOL).Then,we evaluated their self-management condition and their doctors' implementation of the five CR prescriptions.We also investigated the application of TCM and the patients' TCM symptoms and syndromes.2.2 The clinical trial:We did a practical randomized controlled trial(RCT)on CHD patients after PCI in CR stage ?.From May 2017 to November 2018,patients were enrolled in Dongzhimen Hospital.They were randomly divided into the control group(Western medicine CR group)or the intervention group(integrated TCM and Western medicine CR group).The control group was fully implemented with the five CR prescriptions proposed in the guidelines,while the intervention group was given "ruanjian tongmai decoction" on this basis,and took Baduanjin as aerobic exercise in the exercise prescription.Both groups were managed by family CR mode for 12 weeks.Outcome measures included safety indicators,primary outcome measure:QOL;secondary outcome measures:effectiveness of TCM,cardiorespiratory function,cardiac structure and function,vascular endothelial function,self-management efficacy,control of CHD risk factors and disease progression.3 Results3.1 The cross-sectional study:(1)The current state of CR on CHD patients after PCI was as follows:The control of CHD risk factors was not optimistic.Except that the control rate of alcohol consumption achieved 99%,the control rates of other CHD risk factors were short of 80%.66%of the included patients had recurrent cardiovascular events after their first diagnosis of CHD,of which 50%patients had one to three recurrent cardiovascular events.Elderly patients with complications were more likely to have recurrent cardiovascular events.QOL of CHD patients after PCI is generally low,of which the elderly,female and patients with complications had relatively lower QOL.(2)The patients' self-management was moderately correlated with the control of CHD risk factors(r=-0.60,P<0.01)and QOL(r=0.45,P<0.01),and there was much room for improvement in patients' self-management.The included patients showed a relatively good management of emotional cognitive,while the management of bad habits,symptoms,and treatment compliance needed to be strengthened.What's more,the management of disease knowledge,daily life and first-aid needed an urgent improvement.(3)CR prescriptions were highly correlated with the control of CHD risk factors(r=0.70,P<0.01),and moderately correlated with QOL(r=-0.34,P<0.01)and the patients' self-management(r=-0.60,P<0.01).The included patients were given standard drug prescriptions for CR,while the implementation rates of other CR prescriptions were all less than 70%.(4)At the moment,the turning point of the control of CHD risk factors and QOL occurred in CR stage ?,while patients in CR stage ? needed a strengthened intervention to improve the control of CHD risk factors and QOL.(5)Half of the included patients had used TCM as an adjuvant therapy,with one in third used Chinese patent medicine or Chinese herbal medicine respectively,while only seven patients practiced TCM exercises,such as TaiChi or Baduanjin.Our study was not yet able to see the correlations between Chinese medicine and patients' self-management,control of CHD risk factors,recurrent cardiovascular events,QOL,TCM symptoms and syndromes(Qi deficiency and blood stasis)(P>0.05).It showed that exercises may be related with the reduced recurrentcardiovascular events(P<0.05),while there were no correlations between exercises and patients' self-management,control of CHD risk factors,QOL,TCM symptoms and syndromes(Qi deficiency and blood stasis)(P>0.05).3.2 The clinical trial:(1)General information:A total of 72 patients were included in the study,two were excluded in violation of the study plan,six naturally dropped out and were lost to follow-up.Finally,70 patients(36 in the intervention group and 34 in the control group)were included in the full analysis set,and 64 patients(34 in the intervention group and 30 in the control group)were eligible for the scheme set.The two groups had consistent baseline in gender,age,complications,combined diseases and Western medicine prescriptions(P>0.05).(2)Primary outcome measures:The two groups had consistent baseline in QOL before treatment(P>0.05).After treatment,both groups had significantly improved QOL(P<0.01),and the intervention group had higher QOL than the control group(P<0.01),(3)Secondary outcome measures:The two groups had consistent baseline in all the secondary outcome measures before treatment(P>0.05).After treatment,the intervention group had TCM symptoms and syndromes(Qi deficiency and blood stasis),cardiorespiratory function,self-management efficacy,and control of CHD risk factors significantly improved(P<0.01),vascular endothelial function improved to normal range(P<0.05),while cardiac structure and function no significant changes(P>0.05).On the other hand,the control group also had TCM symptoms and syndromes(Qi deficiency and blood stasis),self-management efficacy,control of CHD risk factors significantly improved(P<0.01),left ventricular ejection fraction increased(P<0.05),while cardiorespiratory function,cardiac structure and vascular endothelial function no significant changes(P>0.05).The intervention group had lighter Qi deficiency and blood stasis,and higher self-management efficacy than the control group(P<0.01),while there was no statistical difference in TCM symptoms,cardiorespiratory function,cardiac structure and function,vascular endothelial function and control of CHD risk factors between groups after treatment(P>0.05).The intervention group had a better controlled blood pressure than the control group(P<0.05),while the improvement of control of other CHD risk factors in the two groups was similar after treatment(P>0.05).As in terms of disease progression,one patient decreased bisoprolol fumarate from 5mg Qd to 2.5mg Qd due to the alleviation of angina pectoris symptoms and slow heart rate in the intervention group.In the control group,one patient adjusted the dosage of beta blocker from metoprolol tartrate 6.25mg Bid to metoprolol succinate 23.75mg Qd,according to the original plan;another patient stopped statin because of increased creatine kinase,replaced it with ezetimibe 10mg Qd and replaced Talcom with Ticagrelor 90mg Bid to enhance the anti-platelet aggregation.Other patients followed the original medication regimen without change.(4)Safety indicators:All 64 patients in the eligible scheme set successfully completed the family CR for 12 weeks with no adverse events occurred.4 Conclusions(1)The current CR state of CHD patients after PCI:There is a serious situation about the control of CHD risk factors,they still have recurrent cardiovascular events and their QOL is generally low.The possible causes may be the lack of patients' self-management and the irregularity of doctors'CR prescriptions.(2)On the basis of five CR prescriptions in Western medicine,the advantages of adding"ruanjian tongmai decoction" and Baduanjin,the comprehensive TCM interventions,lie in the following aspects:a better controlled blood pressure,better QOL and self-management efficiency,along with the lighter Qi deficiency and blood stasis in TCM syndromes.And one possible mechanism of these may be the improvement of vascular endothelial function.(3)In addition,through the above research,we can preliminarily conclude that:Under the current medical conditions in China,it is safe and feasible to adopt family CR mode for CHD patients after PCI who belong to middle and low risk with risk stratification in CR stage II.