Clinical Study On Therapeutic Effect Of Traditional Chinese Medicine On CABG During Perioperative Period

Background:The national subject of the11th Five-Year Plan, the Clinical Research of Comprehensive Intervention of Traditional Chinese Medicine After Revascularization of Coronary Artery Heat Disease, respectively evaluated the curative effects and safety of comprehensive intervention of traditional Chinese medicine (hereafter referred to as TCM) after revascularization of CHD (angina and myocardial infarction (hereafter referred to as MI)) with large sample, multi-center, random and controlled clinical trial, so as to provide clinical basis for the preparation of clinical and advantages guide for coronary heart disease. The experimental design adopted multi-center, random, controlled and double-blind clinical trial protocol design.During perioperative period of CABG, patients with coronary artery disease treated with CABG surgery from Guangdong Provincial Hospital of Traditional Chinese Medicine and its cooperative hospitals were selected as cases of illness. There were totally10units, including Guangdong Provincial Hospital of Traditional Chinese Medicine, Guandong General Hospital, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Fujian Provincial Hospital, Xinjiang Uygur Autonomous Region People’s Hospital, Shanxi Provincial People’s Hospital, Gansu Provincial Hospital, Hainan General Hospital, and Shenzhen Sun Yat-sen Cardiovascular Hospital. By referring to the Diagnosis and Treatment Guideline of Stable Angina Pectoris of European Society of Cardiology (ESC) in2006, the Diagnosis and Treatment Guideline of Unstable Angina Pectoris/Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) of American Heart Association (AHA)/American College of Cardiology (ACC) in2005, the patients with CHD (angina and MI) and determined to recive CABG in the seclected time and whose TCM symptom differentiation was heart-qi deficiency and phlegm&blood stasis were selected. The randomazation of patients coronary artery disease treated with CABG satisfying the inclusion criteria was performed,so as to divide them into the treatment group and the control group covering270cases.These two groups of patients all adopted conventional therapeutic protocol of CABG (see therapeutic protocol established by guideline of CABG issued by ACC/AHA in2004for the detail information), and the treatment group adopted agreed No.1prescription of ginseng, halfsummer, red tangerine reel, pseudo-ginseng, and carthamus tinctorius (using boil-free granules) for6months treatment after removing the intrathoracic drain; besides, the control group applied the agreed No.2prescription, the placebo, for6months. Within12months of the study period, there were21excluded cases,25drop-out cases and224finished cases. Finish the conclusion of therapeutic effect of TEM during perioperative period of CABG by concluding and follow-up studying of the below criteria:the death resulted from any reasons during treatment and the follow-up survey, and new case of lethal or non-lethal MI;times of hospitalization because of cardiovascular events and the revascularization which is needed for the recurrence of cardiac ischemic events;angina classification of Canadian Cardiovascular Society (CCCS); cardiac functional grading of New York Heart Assocation (NYHA);Angina Grading Scale;Seattle angina questionnaire (SAQ);quality of life scale of traditional Chinese and western medicine.The results show that in the postoperative follow-up of12months, each time point, there wsa no significant difference between treatment group and control group in all-cause mortality, rate of non-lethal MI, rate of revascularization, The angina classification of Canadian Cardiovascular Society, Cardiac functional grading of New York Heart Disease Association, and in terms of all dimensions of Angina Grading Scale, Seattle angina questionnaire and Chinese traditional and western medicine (P<0.05).Object ive:Case follow-up study was used for follow-up investigation of subjects based on the some studies on coronary artery bypass surgery (CABG) in the subject of the11th Five-Year Plan, the Clinical Research of Comprehensive Intervention of Traditional Chinese Medicine After Revascularization of Coronary Artery Heat Disease, while related data was collected for analysis and evaluation.3-year long-term clinical effects of Chinese traditional treatment during perioperative period of CABG surgery were finally concluded.Methods:The case was taken from some of CABG subject cases of11th Five-Year Plan Clinical Research of Comprehensive Intervention of Traditional Chinese Medicine After Revascularization of Coronary Artery Heat Disease that had already been completed for12-month observation. The follow up started from April2011and finished in December2012, involving224patients, where115patients for treatment group (96male-patients and19female patients, aged62.86±8.098), and109patients for control group (92male patients and17female patients, age63.92±7.011).Method of follow up:The survey was performed by issuing the questionnaire via phone and E-mail and sending the questionnaire with postal mail synchronously.Contents of the follow up:1)Primary outcome:the death resulted from any reasons, and non-lethal MI;2)Secondary outcome:times of hospitalization because of cardiovascular events and the revascularization which was needed by the recurring cardiac ischemic events;3)The angina classification of Canadian Cardiovascular Society (CCCS);4)The cardiac functional grading of New York Heart Disease Association (NYHA);5)Angina Grading Scale;6)The Seattle angina questionnaire (SAQ);7) Quality of life scale of TCM and western medicine.Time of follow up:Three years after surgery for both groups.Results:After3years of follow-up,16cases lost to follow-up (13were due to the changes of telephone numbers and addresses, one refused to answer the questionnaire, and2refused to be investigated). Hence,208patients were finally followed up, where treatment group was106patients, and control group was102patients. The Angina Grading Scale, SAQ and quality of life scale of TCM and western medicine were completed for follow up,103patients for treatment group and99patients for control group (3deaths for both groups). the cases for non-lethal MI:there was1cases from treatment group and3cases from control group(P=0.362);the cases for revascularization:there was1 cases from treatment group and4cases from control group (P=0.205); times of readmission to the hospital resulted from cardiovascular event:from treatment group, there was1case for both one-time and two-time readmission to the hospital resulted from cardiovascular event. In contrast, there were5cases from control group for one-time readmission to the hospital resulted from cardiovascular event and3cases for two-time readmission to the hospital resulted from cardiovascular event (P=0.043). Canadian angina classification:there were92cases of1-level,11cases of2-level, no case of3-level and4-level from treatment group;besides, there were80cases of1-level,18cases of2-level,1case of3-level and no case of4-level from control group (P=0.086). Cardiac functional grading of New York Heart Disease Association (NYHA):there were88cases of1-level,14cases of2-level,1case of3-level and no case of4-level from treatment group;besides, there were71cases of1-level,24cases of3-level,4case of3-level and no case of4-level from control group(P=0.015).There was no significant difference between treatment group and control group in terms of all dimensions and total scores of Angina Grading Scale (the score of anginal frequence, treatment group was0.19+0.595, control group was0.32±0.740, P=0.173. the score of anginal time, treatment group was0.25±0.825, control group was0.34±0.859, P=0.443. the score of angina pectoris degree, treatment group was0.26±0.681, control group was0.36±0.920, P=0.188. the score of nitroglycerin doses, treatment group was0.14±0.506, control group was0.20±0.728, P=0.453. the total score of Angina Grading Scale, treatment group was0.66±2.046, control group was1.03±2.447, P=0.244).There was no significant difference between treatment group and control group in terms of dimensions of Seattle angina questionnaire (SAQ)(the score of physical limitation, reatment group was73.12±7.99, control group was72.53±9.73, P=0.624. the score of anginal stability, treatment group was89.81±19.31, control group was86.62±24.04, P=0.529. the score of anginal frequency, treatment group was95.73±10.44, control group was92.93±14.30, P=0.292.the score of disease recognition, treatment group was84.39±15.69, control group was82.66±18.12, P=0.470. the score of treatment satisfaction, treatment group was88.24±13.05, control group was84.91±15.90, P=0.105). There was no significant difference between treatment group and control group in terms of all dimensions and total scores of Quality of life scale of traditionl chinese and western medicine (the score of symptoms, treatment group was82.77±5.62, control group was81.52±7.77, P=0.774. the score of life, treatment group was86.33±9.55, control group was85.25±10.75, P=0.452. the score of psychology, treatment group was85.48±8.73, control group was84.00±8.91, P=0.236. the score of social intercourse, treatment group was96.31±8.44, control group was96.57±6.83, P=0.814. the total score of Quality of life scale of traditionl chinese and western medicine, treatment group was90.90±5.27, control group was89.83±7.77, P=0.227).Conclusion:During perioperative period of CABG, treatment with TCM can reduced rehospitalization rate3years after opertation and improved the NYHA Cardiac functional grading3yeas after operation.