Objective:Appraise the security and effectivity of XinYi capsule in the treatment of coronary heart disease stable angina pectoris (the syndrome of Qi-deficiency and blood stasis)preliminarily, and study the dose-effect relationship, to provide reasonable evidence for corroborative study at stage III.Methods:According to the principle of block-radomize, double-blind, simulate, parallel-placebo control design, we selected all the 60 cases of patients with the syndrome of Qi-deficiency and blood stasis to observed. They were divided into three groups at random, the high-dose group, low-dose group and control group, each had 20 cases of patients and treated with XinYi capsule,XinYi capsule+analogic dose,analogic dose respectively. All the patients were treated with 4 weeks. The changes of clinical symptoms and laboratory indexes in all patients were observed before and after treatment.Results:(1) The curative effect index:the total effective rates on angina pectoris of the high-dose group were 78.95%,the rate of excellence were 52.63%; while 58.82% and 29.41% in the low-dose group; the total effective rates of the control group were 26.32%.The comparison in three groups had statistical significance (P<0.01);there was no statistical significance between the high-dose group and low-dose group (P>0.05). (2)The safety index:. Analyze all the changes of clinical symptoms and laboratory indexes in all patients before and after treatment with SPSS 17.0, no obvious and serious side effects were found.Conclusion:This research proved that XinYi capsule could relieve the angina pectoris of patients with with the syndrome of Qi-deficiency and blood stasis. And no obvious and serious side effects were found in the research. |