| Objective:To study the curative effect mechanism of Shenzhitongmai soft capsule on clinical symptom of coronary heart disease angina pectoris (Qi-deficiency and blood stasis) and IL-6 level in patients, discuss a preliminary evaluation of its safety and effectiveness and part of its clinical mechanism.Methods:According to the principle of block-radomize, double-blind, the placebo controled parallel design, which was multi-center clinical trials for study we selected a total of 48 angina pectoris patients with the syndrome of Qi-deficiency and blood stasis to observed. They were divided into two groups at random. The experimental group had 24 patients who were given Shenzhitongmai soft capsule , the control group had 24 patients given Shenzhitongmai soft capsule simulation agent, 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 experimental group with symptoms of angina, symptoms of Chinese medicine, ECG effect of nitroglycerin stop minus the rate of total effective rates were 91.67%,79.17%,83.33%,83.33%,the results of the control group were12.5%,4.17%,0,4.17%, two was statistical difference in three groups(p<0.05).2.The levels of IL-6 in the experimental group was lower than those before treatment, and two was signal statistical difference(p<0.01);but two was no change in the control group about the levels of IL-6 and no statistical difference(p>0.05).3.In safe effects, no obvious and serious side effects were found.Conclusions:1.Shenzhitongmai soft capsule is a safe and effective preparation on the treatment of stable angina patients.2.The methods of Supplement Qi and promoting blood circulation and are effective in treatment of stable angina patients with heart Qi-deficiency and blood stasis .3.Shenzhitongmai soft capsule can decrease the consistency of IL-6 and Inhibiting the inflammatory reaction of blood vessel endothelium remarkably in the stable angina patients, which may be one of mechanism action to treat coronary heart disease myocardial ischemia. |