| Objective To evaluate of the efficacy of the three treatments and the relevance of related biological indicators, to confirm the combination of diseases with differentiation of syndromes and that the correspondence of formula and syndrome are the core of traditional Chinese medicine and the key to improve the clinical efficacy, so that to further explore the relevance of disease, syndrome and formula by the methods of RCT and observation of the three kinds of treatment of correspondence of formula and syndrome, the minor correspondence of formula and syndrome, conventional western medicine intervention in coronary heart disease angina.Methods 198 cases of coronary heart disease confirmed by coronary angiography in four centers were selected.99 of them were authenticated to the syndrome of Qi deficiency and blood stasis; others belonged to syndrome of phlegm and blood stasis. Randomized and double-blind, double dummy trial were carried out. All the patients were divided into three groups, which were are correspondence group of formula and syndrome (group A), minor correspondence group of formula and syndrome (group B) and conventional western medicine group (group B). On the basis of conventional western medicine, the patients in group A, Qi deficiency and blood stasis syndrome were given SHENSHAO and DANLOU simulation agent, phlegm and blood stasis syndrome were given DANLOU and SHENSHAO simulation agent, the patients in group B, Qi deficiency and blood stasis syndrome were given DANLOU and SHENSHAO simulation agent, phlegm and blood stasis syndrome were given SHENSHAO and DANLOU simulation agent, the patients in group C, all were given SHENSHAO simulation agent and DANLOU simulation agent. After 28 days of treatment, we observed the effect of Traditional Chinese medicine syndrome,the effect of disease,the improvement of the patients'life quality and effect of biological indicators, and using MDR to nine major factor modeling, simultaneous detection of multiple factors influence the different effect.The results The effect of Traditional Chinese medicine syndrome, the effect of disease, the improvement of the patients' life quality and expression of inflammatory cytokines, plaque factor, thrombosis factor in group A are better than that of group B and group C. The effect of disease and the improvement of the patients'life quality in group B are better than that of group C, but difference of the improvement of objective indicators isn't significantly between this two groups. By MDR more than 9 different factors were analyzed, the results suggest different groups (different treatment) are the main factors to improve the clinical curative.1, The effect of angina pectoris:The difference of the results before and after treatment in three groups are statistically significant in the aspect of frequency and the duration of angina pectoris attack (p=0.000)。The results in group A are better than that in group B and C, and there are statistically significant differences (F=53.384 P=0.001). However, there is not significantly difference between group B and C (p=0.046).2, The effect of traditional Chinese medicine syndrome:The difference of the results before and after treatment in three groups are statistically significant in the aspect of chest tightness, chest pain, shortness of breath (p=0.000)。The results in group A are better than that in group B and C, and there are statistically significant differences (F=74.114 P=0.000). However, there is not significantly difference between group B and C (p=0.065).3, The effect of life quality scale:The difference of the results before and after treatment in three groups are statistically significant in the aspect of life quality improvement, such as physical function, psychological function and social awareness (P=0.000)。The results of group B is better than that of group C in the aspect of "stability of angina", "the situation since the onset of colic," "treatment satisfaction" (P<0.05), which shows that the treatment of minor correspondence of formula and syndrome can also improve the quality of life in angina patients to some extent.4, The effect of objective indicators:Inflammatory Factor (sensitivity C-reactive protein,CD40 ligand,Homocysteine,Interleukin-6):The difference of the results before and after treatment in three groups are statistically significant in the aspect of inflammatory factors (p=0.000). The inflammatory factor in group A are lower than that in group B and C, and the difference is statistically significant (p=0.000). However, there is not significantly difference between group B and C (p>0.05).Plaque Factor (Matrix metalloproteinase,Myeloperoxidase,Vascular cell adhesion molecule):The difference of the results before and after treatment in three groups are statistically significant in the respect of plaque Factor (p=0.000). The indicators in group A are lower than that in group B and C,and the difference is statistically significant (p=0.000). However, there is not significantly difference between group B and C (p>0.05).Thrombosis factor(P-selection,Thromboxane,Von Willebrand factor):The difference of the results before and after treatment in three groups are statistically significant in the respect of thrombosis factor (p=0.000). The indicators in group A are lower than that in group B and C, and the difference is statistically significant (p=0.000). However, there is not significantly difference between group B and C (p>0.05).Endothelial growth factor (ET,Vascular endothelial growth factor,Insulin-like growth factor I):The difference of the results before and after treatment in three groups are statistically significant in the respect of endothelial growth factor(p=0.000). However,there is not significantly difference among three groups (p>0.05).5 By analyzing 9 different factors affected clinical curative through using MDR, we found that both angina pectoris, efficacy or biological efficacy of TCM symptoms, group is the most important factor which far more than any other a factor, clearly the parties to obtain evidence of clinical efficacy of correspondence is the key.Conclusion The treatment of correspondence of formula and syndrome can not only improve the clinical symptom scores in Chinese medicine, times and degree of angina attack, and life quality, but also plays a better role from a biological basis than minor correspondence of formula and syndrome and conventional western medicine. In the different syndrome of diseases, the effect depends on correspondence of disease and syndrome. The study shows the relevance of diseases, syndromes, and formula from both macro and micro aspects, and investigates the clinical content of correspondence of disease and syndrome, and formula. |
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