| ObjectiveIn this study,on the basis of routine drug treatment for patients with non-ST-segment elevation acute coronary syndrome（QI and blood stasis type）who were scheduled to undergo elective PCI,the addition of Buyang Huanwu Decoction Modified during the perioperative period of PCI.To explore the effects of "Buyang Huanwu Decoction Modified" after PCI in non-ST-segment elevation acute coronary syndrome.Meanwhile,from the etiology,pathogenesis,rationale,prescription and other aspects to discuss its efficacy,study its pharmacological effects and treatment mechanisms.MethodsThe data of patients with NSTE-ACS（Qi deficiency and blood stasis type）who were to undergo elective PCI in the Department of Cardiovascular Medicine,Guanggu Branch,Hubei Provincial Hospital of Traditional Chinese Medicine from September 2020 to December 2021 were collected,and were divided into two groups according to the method of randomization.The control group was given standardized treatment according to the clinical diagnosis and treatment standard,and the observation group was given Buyang Huanwu Decoction 3 days before PCI on the basis of the treatment plan of the control group.After 4 weeks of surgery,the related data of TCM clinical syndrome score,TCM clinical syndrome efficacy index,ECG efficacy,the distance of 6MWT,SF-36 score in the observation group and control group were collected and analyzed statistically.Results1.A total of 67 subjects completed the observation of this clinical study,including 32 cases in the observation group and 35 cases in the control group.The two groups were comparable in demographic characteristics（age,gender）,risk factors and past history（Smoking,Hyperlipidemia,Hypertension,Diabetes）,preoperative use of low molecular weight heparin,the number of vascular lesions and stents（P>0.05）.2.Comparison of TCM syndrome scores:（1）Individual syndrome scores:There was no statistical difference in the individual syndrome scores between the two groups before surgery,but they were comparable（P>0.05）.The intra-group comparison of each individual syndrome score between two groups before surgery and 4 weeks after surgery.Except for the comparison of spontaneous perspiration and shortness of breath scores of control group had no statistical significance（P>0.05）.The others at 4w after operation were all lower than those before operation,and the difference was statistically significant（P<0.05）.Comparing the scores of each individual syndrome between the two groups at 4 weeks after the operation,the TCM syndrome scores of the observation group were significantly such as chest pain,chest tightness,fatigue,spontaneous sweating and tongue and pulse lower than those of the control group,and the difference was statistically significant（P<0.05）.However,there was no significant difference between the two groups in TCM syndrome scores in palpitations and shortness of breath（P>0.05）.（2）The total score of TCM syndromes: the total scores of TCM syndromes before operation in the two groups were comparable（P>0.05）.The total scores of TCM syndromes in the two groups 4w after operation were decreased compared with those before operation,and there was a statistical difference（P<0.05）,and the improvement of the total score of TCM syndromes in the observation group was better than that in the control group,and the difference was statistically significant（P<0.05）;（3）TCM syndrome efficacy index : The TCM syndrome efficacy index of the observation group was better than that of the control group,and the difference was statistically significant（P<0.05）.3.6min walking test: There was no significant difference in the 6MWT distance between the two groups at 5d after operation（P>0.05）.The 6MWT distance at 4w after operation was increased compared with that at 5d after operation,and the increase in the observation group was more obvious,and the differences were statistically significant.（P<0.05）.4.ECG curative effect: The observation group had better curative effect in terms of ECG changes,and the difference was statistically significant（P<0.05）.5.SF-36: There was no significant difference in the scores of emotional function and mental health between the two groups at 4w after operation and before operation（P>0.05）.The scores of physiological function,role physical,physical pain,general health,energy and social function at 4 weeks after operation were better than those before operation,and the difference was statistically significant（P<0.05）;and at 4 weeks after operation,the scores of physical function,physical pain,general health,and energy in the observation group were higher than those in the control group.The difference was statistically significant（P<0.05）;however,the difference between the two groups in terms of physical function,social function,emotional function,and mental health was not statistically significant（P>0.05）.6.In terms of drug safety evaluation: During the observation period,1patient in the control group had abnormal liver function（less than twice the normal value）,and the patient’s liver function returned to normal after follow-up,which was considered to be related to the side effects of lipid-lowering drugs liver injury;no adverse reactions and no MACEs occurred event happened.Conclusion1.The use of Buyang Huanwu Decoction in the perioperative period of PCI can effectively improve the clinical syndromes of patients with traditional Chinese medicine,especially in the aspects of chest tightness,chest pain,fatigue,and spontaneous perspiration.2.Buyang Huanwu Decoction can improve ECG,increase walking distance of 6 minutes,improve patients’ exercise tolerance,improve clinical efficacy and benefit prognosis.3.Buyang Huanwu Decoction is beneficial to improve the quality of life of patients,especially in terms of physiological functions,physical pain,general health,energy,etc.4.No drug safety problem was found during the clinical observation period of Buyang Huanwu Decoction Modified,which can provide a basis for the clinical application of NSTE-ASC（Qi deficiency and blood stasis type）patients in the perioperative period of elective PCI. |
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