| Objective:To evaluate the clinical safety and efficacy of GXDS granules in treating table angina pectoris in CHD(syndrome of qi stagnation and blood stasis).Methods:Select 480 cases who suffer from stable angina pectoris in CHD(syndrome of qi stagnation and blood stasis)following stratified blocked randomization,double-blindness,multicenter trial method.According to the principle of 3:1 distribution they were randomly divided into treatment group 360 cases,control group 120 cases.Among them,160 cases will accepted Duke Treadmil test,including 120 cases in experimental group and control group 40 cases,The treatment group will given GXDS granules and simulation of guanxinkang granules,Meanwhile,The control group were also given the corresponding treatment dose of guanxinkang granules and simulation of GXDS granules.After four weeks as one course,they were observed the classification score of coronary heart disease angina,traditional Chinese medicine(TCM)symptom score,single symptom scores and the frequency of angina pectoris episodes before and after the treatment to evaluate the effectiveness of drugs.Meanwhile,In the process of the test patients were observed the laboratory indexes of the urine routine,blood routine,blood biochemistry,liver function(Alanine aminotransferase(ALT),Aspertate aminotransferase(AST),Total bilirubin(Tbil),alkaline phosphatase(AKP),?-gamma glutamyl transpeptidase(?-GT)),creatinine(Cr),urea nitrogen(BUN),electrocardiogram(ECG)and so on,the incidence of adverse reactions were also be observed,in order to evaluating the safety of GXDS granules.Results:GXDS granules can significantly improve the symptoms of stable angina pectoris in CHD(syndrome of qi stagnation and blood stasis)and has high safety.Curative effect evaluation:Comparison of the two groups'efficiency,the total effective rate about curative effect of traditional Chinese medicine syndrome before treatment and after based on FAS,the differences were no statistically significance(P>0.05);Comparison the differences of Coronary heart disease angina pectoris grade 14d changes to the baseline,between groups was statistically significant(P=0.027),the pain grading reduced to some extent after taking dugs,of which the most were experimental group;Comparison of differences about Anginal attacks over the past two weeksin the group before and after,the differences were statistically significance(P<0.05),the number of attacks to some extent reduce after taking medicine;Comparison of the Attack frequency of angina pectoris daily,the difference before and after in the groups were statistical significance(P<0.05);Comparison of the average duration time with each experimental group and control group by angina attack treating before and after,the differences had statistically significance(P<0.05),experimental group reduce more;The total score of TCM syndrome 14d experimental group results before treatment and the difference value is greater than the control group,difference between groups was statistically significant(P=0.011);The duration of angina score results 14d score was lower than the control group and experimental group,the difference was statistically significant(P=0.039),heart palpitations grading results in the control group of 14d and 28d scores were lower than the experimental group,the difference was statistically significant(P<0.05),and the curative effects in the experimental group was better than the control group.Safety evaluation:During the experiment,there was no serious adverse events occurred.The treatment group and control group's incidence of adverse events were 2.8%and 3.3%respectively,the incidence of adverse reactions in treatment group was 0.8%,There was no adverse events that can judging adverse reactions in the control group.There was no statistically significant(P>0.05)difference between the two groups' incidence of adverse events and the incidence of adverse reactions.These all means that GXDS granules has high clinical security.Conclusion:GXDS granules can significantly improve patients'angina pectoris symptoms who with stable coronary heart disease angina pectoris(syndrome of qi stagnation and blood stasis),The two main indexes of TCM syndrome curative efficacy and grading evaluation of coronary atherosclerotic hearth disease efficacy were higher than the control group Guanxinkang granules.Compared with Guanxinkang granules,the advantages of nitroglycerin stopped reduction rate was very obviously,the security of clinical application was better. |
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