| Unstable angina which is a clinical syndrome between stable angina and acute myocardial infarction is one type of coronary atherosclerotic heart disease. It has the character of changing quickly, which could shift to sudden death or acute myocardial infraction, threatening the health of human. In recent decades, the incidence of unstable angina pectoris mortality was significantly increased with the improvement of living standards of our people, which has become one of the focuses in cardiovascular research field. Coronary heart disease and unstable angina belong to chest stuffiness and pain in Chinese medicine. Pathogenesis characteristic is deficiency in origin and excess in superficiality. The disease being located in heart, but there close relation between heart and spleen and stomach. The main cause of the disease is the deficiency of the spleen and stomach. Treatment based on differentiation of disease should regulate the spleen and stomach, for the basic pathogenesis of unstable angina can be divided into Qi deficiency, phlegm and stagnation of blood. So benefiting Qi, invigorating the spleen, promoting blood circulation to remove blood stasis, dredging the meridian are needed and provided a theoretical basis for the drug.Objectives:To observe the effect and safety of Tiaopihuatang Granules treating unstable angina (syndromes of Qi deficiency, phlegm and stagnation of blood) and the impact of plasma Hs-CRP, serum homocysteine and blood lipid, discuss the mechanism of Tiaopihuatang Granules on treating unstable angina.Methods:All cases come from hospitalized sufferer with the date integrity in cardiovascular department of the Third affiliated hospital of Nanjing University of traditional Chinese medicine (TCM), from January 2008 to March 2009.62 cases of patients with UAP were randomly divided into treatment group (32 cases) and control group (30 cases). All patients'clinical symptoms conform to the diagnosis standard of unstable angina pectoris; and at the same time, conform to the syndromes of Qi deficiency, phlegm and stagnation of blood. The treatment group and the control group have no statistic difference in age, sex, the time of disease, complication and clinical symptoms (P>0.05). The patients in treatment group take Tiaopihuatang Granules plus standard western medicine the patients in control group take Xuefuzhuyu Capsules with standard western medicine. All clinical data were compared after 4 weeks'treatment. For all patients, general conditions, angina pectoris symptoms, ECG, syndromes and signs were observed. Further more, plasma Hs-CRP, serum homocysteine and blood lipids were tested before and after treatment. The statistic method: The data was analyzed after observation. The measurement data, enumeration data and the rank data were examined with Chi-square test, T-test and Wilcoxon signed rank test. Result:1 The clinical curative effective of angina pectoris syndromes, the total effective rate of the treatment group and the control group are 93.75% and 73.3% respectively, there are statistical different between the two groups(P<0.05). In effects of improvement of angina pectoris, the treatment group shows very significant difference on reduce the onset frequency and severity of angina pectoris than that of control group(P<0.05 or P<0.01).2 In syndrome of TCM, the total effective rates of the treatment group and the control group are 90.63% and 66.67% respectively, there are statistical different between the two groups(P<0.05).3 In electrocardiogram improvement, the total effective rates of the treatment group and the control group are 71.87% and 56.67% respectively, there are statistical difference between the two groups(P<0.05).4 The clinical results show that plasma Hs-CRP and serum homocysteine level after treatment are lower than those before the treatment in the two groups (P<0.01). And the treatment group is superior to the control group(P<0.01).5 The clinical results show that the level ofTC,TG,LDL-C,Lp(a) after treatment are lower than those before the treatment in the treatment group(P<0.05 or P<0.01). And the level of TC,LDL-C,Lp(a) after treatment are lower than those before the treatment in the control group(P<0.05), but the level of TC,LDL-C,Lp(a) has statistical difference comparing the treatment group with the control group(P<0.05).Conclusion:The study indicates that Tiaopihuatang Granules has favorable clinical curative effect on unstable angina pectoris patients with the syndromes of Qi deficiency, phlegm and stagnation of blood, can alleviate angina pectoris, improve blood supply of cardiac muscle and discontinue the rate of nitroglycerin. Tiaopihuatang Granules can reduce significantly the level of TC,TG,LDL-C,Lp(a) and the level of plasma Hs-CRP and serum homocysteine in the patients with unstable angina. The study abundances the research of TCM treatment on unstable angina, Tiaopihuatang Granules is worthy of using in the clinical practice widely. It's mechanism could relate to regulating blood lipid, preserving the function of vessel endothelia, restraining the inflammation reaction, increasing anti-coagulation activity, reducing the platelet adhesion and intervening thrombosis.
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