| During the development process of traditional chinese medicine (TCM) and modern medicine, clinical pattern of diagnosis and treatment about syndrome differentiation and treatment in TCM and treatment based on disease differentiation in modern medicine formed. Currently, the study on combination of disease and syndrome which lies in syndrome differentiation in TCM binding disease diagnosis in modern medicine has become the main pattern of syndrome. Combination of disease and syndrome with prescription corresponding to syndrome is the key of clinical effect. Combination of prescription and syndrome, putting up a bridge between principle-method-recipe-medicines,exploration of the internal relations of them, which can improve the level of clinical syndrome differentiation and treatment. Therefore, prescription corresponding to syndrome is the best starting point of integrative chinese and western medicine study. Carrying out the study of combination of disease and syndrome and prescription corresponding to syndrome contributes to enrich and perfect the theoretical system and treatment methods of TCM,which is of great significance for revealing the mechanism of the classic prescription and the essence of syndrome.Coronary heart disease(CHD)is one of the main disease harmful to human health, which has become one of the leading causes of death, so prevention and treatment of CHD is still the focus of medical research. Unstable angina (UA), one of the major types of CHD, belongs to the scope of acute coronary syndrome(ACS).UA has characteristics of changing fast and danger, which should be diagnosed and treated timely. Modern medicine has become a series of standard for diagnosis and treatment, and TCM in treating CHD has its own advantages. With a clear diagnosis plus TCM treatment, it can further improve the efficacy, quality of life and improve prognosis. In this study, on the basis of combination of disease and syndrome, patients with UA who were diagnosed by coronary angiography(CAG) were selected to take part in this trial. Using the classic formula Xuefuzhuyu capsules and Shengmai capsules to interference UA with prescription corresponding to syndrome or non-corresponding, collecting clinical information multiple timepoint, to explain the mechanism of prescription corresponding to syndrome and to explore the dynamic change of syndrome under the guide of theory.PurposeTo observe the effect and dynamic change of syndrome factors of UA intervened with prescription corresponding to syndrome or non-corresponding, and to explain the mechanism of prescription corresponding to syndrome and the dynamic change characteristics of syndrome. Methods88 cases with UA diagnosed by CAG were studied. including blood stasis group(44 cases), deficiency of both Qi and Yin group(44 cases). Using a randomized, double-blind, double dummy research methods, Xuefuzhuyu capsules and Shengmai capsules were administrated to intervene with patients. Clinical information were collected before and after treatment 1 week,2 weeks,3 weeks,4 weeks, including symptoms, signs, TCM syndrome and laboratory objective markers. After the test:①To compare the efficacy of two interventions, including angina pectoris, the main symptoms and signs, ECG effects, curative effect of TCM, laboratory markers of efficacy, quality of life effects;②To observe the dynamic change of syndrome of patients with UA in two interventional ways, using survival analysis and repeated measures analysis of variance methods, mainly including symptoms frequency, syndrome factor frequency, syndrome factor points, syndrome factors combination and biological markers③To explore the relationship between syndrome factors and biological markers.Results1. Comparison of therapeutic effects:During experimental period, six cases fell off, a total of 82 cases were involved into statistical analysis.①angina pectoris:the effective rate of prescription corresponding to syndrome and non-corresponding in blood stasis group was 80.95%,50.00%, respectively, the former was better than the latter(P＜0.05); the effective rate of prescription corresponding to syndrome and non-corresponding in deficiency of both Qi and Yin group was 76.19%,55.00%, respectively, there was no statistical significance (P>0.05); the total effective rate in prescription corresponding to syndrome and non-corresponding group was 78.57%,52.50%, respectively, the former is better than the latter (P＜0.05).②ECG effects:the effective rate of prescription corresponding to syndrome and non-corresponding in the whole group was 73.81%,57.5%, respectively, there was no statistical significance (P>0.05).③main symptoms and signs:the improvement of chest distress, palpitations, shortness of breath, malaise and fatigue, spontaneous perspiration in prescription corresponding to syndrome group was better than non-corresponding group (P＜0.05), but in improving the chest pain, aversion to cold, soreness of loins and knees, insomnia in the two group, there were no statistical significance(P>0.05).④TCM syndrome: the effective rate of prescription corresponding to syndrome and non-corresponding in blood stasis group was 85.71%,50.00%, respectively, while in deficiency of both Qi and Yin the rate was 80.95%,45.00%, respectively,the former is better than the latter (P＜0.05); the total effective rate in the whole group was 83.33%,47.50%, respectively, also, the former is better (P＜0.05).⑤biological markers:The level of hs-CRP, Hey, MPO, MMP9, ET in the blood stasis group treated with prescription corresponding to syndrome decreased after treatment (P<0.05 or P＜0.01), but they did not decrease in non-corresponding group (P>0.05),the former is better than the latter; while in deficiency of both Qi and Yin group all the five markers decreased despite of prescription corresponding to syndrome or not(P<0.05 or P<0.01)after treatment, but there were no ststistical significance between two kinds of methods; when comparison of all cases,these markers in those who were treated with prescription corresponding to syndrome decreased more than those treated with non-corresponding(P<0.05). The level of PAF, PAG, BNP after treatment in all groups were lower than that before treatment(P<0.05 or P＜0.01), but there were no statistical significance among the groups after treatment (P>0.05). Four Items of Blood-lipid Tests:there were statistical significance in lowering the level of TG, TC, LDL-C (P＜0.05), and increasing the level of HDL-C before and after treatment in each group (P<0.05), but there was no statistical significance between the two groups after treatment(P>0.05).⑥SAQ:before and after treatment in each group, AS, AF, TS, DP points decreased, there were statistical significance (P<0.05 or P<0.01), when added into all, points lowerd more in those who were treated with prescription corresponding to syndrome than those treated with non-corresponding (P＜0.05). PL points did not lower in each group before and after treatment (P>0.05).2. Dynamic changes of syndrome:①symptoms:the disappearance time of chest distress, palpitations, spontaneous perspiration, shortness of breath symptoms in prescription corresponding to syndrome group was earlier than non-corresponding group(P<0.05), while there were no statistical significance about disappearance time of chest pain and other symptoms in non-corresponding group(P>0.05);②frequency of syndrome factors:when treated with prescription corresponding to syndrome, the onset time about blood stasis and Qi deficiency was earlier than non-corresponding (P＜0.05), while the onset time about Yin deficiency of two kinds of methods was not statistically significant(.P>0.05);③points of syndrome factors:when treated with prescription corresponding to syndrome, the onset time of syndrome points reduction about blood stasis, Qi deficiency, Yin deficiency was earlier than non-corresponding (P＜0.05 or P＜0.01), after treatment of 1 week in blood stasis and 2 weeks in Qi deficiency and Yin deficiency there were statistical significance, while it was as well after treatment of 3 weeks in blood stasis and 4 weeks in Qi deficiency and Yin deficiency when treated with non-corresponding,④combination of syndrome factors:when treated with prescription corresponding to syndrome, the combination of two syndromes gradually increased while the combination of three syndromes gradually decreased. when treated with non-corresponding, the change trend of combination of syndromes is contrary to that.⑤biological markers:when treated with prescription corresponding to syndrome, the level of hs-CRP, Hey, ET, MPO, MMP9 decreased after treatment of 1 week that is statistically significant (P<0.01), while treated with non-corresponding, the level of MPO, MMP9 fell after 2 weeks, and the level of hs-CRP, Hey, ET did after treatment for 3 weeks only, which showed statistical significance (P<0.01).3. The relationship between syndrome factors and biological markers:Blood stasis syndrome and PAF was closely related which suggests the main pathology of blood stasis is platelet activation. Qi deficiency related BNP, PAG which suggests cardiac insufficiency and platelet aggregation. Yin deficiency was related to Hey, BNP and ET, but the degree of relation was minor and had little value for diagnosis. Qi stagnation was associated with ET, MPO which suggests inflammatory reaction and impaired endothelial function. Turbid phlegm well correlated TC, hs-CRP, TG. which implicate hyperlipemia and inflammatory reaction. Heat deposition was correlated with hs-CRP, MMP9 which hint inflammatory reaction. And also, Yang deficiency closely related to BNP which suggests cardiac insufficiency. Cold coagulation was associated with BNP, Hey, MMP9 which suggest cardiac insufficiency and inflammatory reaction.Conclusion1. Unstable angina treated with prescription corresponding to syndrome, the overall effect of angina, the effect of symptoms of chest distress, palpitations, shortness of breath, spontaneous perspiration, the effect of TCM syndrome, the effect of some biological marker such as hs-CRP, Hey, MPO,MMP9, ET, and SAQ efficacy were better than non-corresponding treatment.2. Unstable angina treated with prescription corresponding to syndrome, the onset time of some symptoms such as chest distress, palpitations, spontaneous perspiration,shortness of breath, the disappearance time of syndrome factors such as blood stasis and Qi deficiency, the falling time of syndrome points of blood stasis,Qi deficiency and Yin deficiency were earlier than non-corresponding treatment. Combination of syndromes changed toward to simple trend when intervention with prescription corresponding to syndrome while varied toward to a complicated trend when intervention with non-corresponding. The onset time of some biological markers was earlier in prescription corresponding to syndrome treatment than non-corresponding treatment.3. Syndrome factor has close relationship with some certain biological markers which can provide reference for the diagnosis.
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