| Objective:This clinical research on Xinyi capsule in the treatment of stable angina pectoris of coronary heart disease (Qi deficiency and blood stasis) in patients with angina pectoris curative effect, the treatment of stable angina pectoris of coronary heart disease (Qi deficiency and blood stasis) and evaluate the safety and effectiveness, to provide a reasonable according to the validation study.Methods:Through a randomized, placebo parallel controlled clinical trial method, in 2013 November to 2014 October in Department of outpatient diagnosis of First Affiliated Hospital of Heilongjiang University Of Chinese Medicine and the hospital, coronary heart disease with stable angina pectoris (Qi deficiency and blood stasis) diagnostic criteria, at the age of 40-65 years old patients of 72 cases for clinical research. The patients were divided into experimental group of 54 cases,18 cases of the control group. There are lead-in period (2 weeks) and the treatment period (8 weeks) in the trial. Lead-in period both groups used XinYi capsule’s mimetic, while the treatment period the experimental group received XinYi capsule, XinYi control group taking capsule’s mimetic. During the attack of angina pectoris,10 minutes of two groups of patients can not ease the sublingual nitroglycerin. The Seattle angina questionnaire, evaluation of curative effect, TCM syndrome integral ECG curative effect, blood biochemistry (liver function, renal function and other indexes were analyzed statistically) changes and the effect of.Results:(1) The grouping of two groups of patients in age, sex, disease progression, degree is not statistically difference. (2) ECG curative effect of two groups of patients had significant difference (P<0.05),Experimental medicine group was better than control group.(3) After treatment, two groups of patients in the Seattle angina questionnaire and TCM syndrome efficacy evaluation indicators, with significant difference (P<0.05), and the traditional Experimental medicine group has curative effect, while the control group did not have the curative effect, TCM syndrome integral evaluation of curative effect was 51.85%,5.56% in the control group. (4)The liver function of patients before and after treatment (ALT,AST), renal function(BUN,Cr) had no significant difference (P>0.1), no serious adverse events occurred during the test.Research conclusions:(1) Xinyi capsule has a therapeutic effect on electrocardiogram curative effect evaluation, and can improve the ECG of myocardial ischemia. (2) The xinyi capsule can significantly improve patients with stable angina pectoris of coronary artery disease angina symptoms and TCM syndrome integral. (3)During the study of xin yi capsules did not cause kidney damage. |