Clinical Study On Separated Complex Prescription Of Xuefu Zhuyu Decoction

Clinical Study on Separated Complex Prescription of Xuefu Zhuyu DecoctionBackground: To investigate the law of prescription compatibility is the key of prescription study in which the separated complex prescription is the most important method. Most of previous animal studies explored the separated complex prescription and lacked in clinical trail.Objective: To probe into clinical therapeutic effects of separated TCM compound recipe Xuefu Zhuyu Decoction for combination of disease and syndrome, so as to further expound the law of TCM recipe formulation. Methods: Adopting randomized double blind placebo control clinical trail design, 131 cases were randomly divided into Xuefu Zhuyu group, refine Xuefu Zhuyu group, drug-pair group and placebo group. Each case was administered 10ml each time, third daily, 4 weeks as one course. At same time, normal western medicine and symptomatic treatment were given. There were no significant differences in baseline characteristics among the four groups(P>0.05).Paroxysm times of angina pectoris, dosage and times of nitroglycerin, the time of medicine producing action and the lasting time of medical action, cumulative score of the blood stasis and qi stagnation syndrome were recorded, and electrocardiogram (ECG), changes of clinical symptoms ,quality of life, blood lipids, hemorheological indexes, levels of NO, ET, t-PA,ox-LDL, ILr6, IL-8, Hs-CRP, CD41 and CD62P in patients before and after treatment were detected. The adverse reactions to the treatment wererecorded. Results:1. The therapeutic effect for angina pectoris of coronary heart disease was in order of Xuefu Zhuyu group, refine Xuefu Zhuyu group, drug-pair group and placebo group (P<0.01);2. The therapeutic effect for blood stasis and qi stagnation of syndrome was in order of Xuefu Zhuyu group, refine Xuefu Zhuyu group, drug-pair group and placebo group (P<0.01). According to the standard of the evaluation, the results showed Xuefu Zhuyu groups in improvement of insomnia, headache, and numbness of limbs, weakness, and amnesia were superior to the placebo group. Xuefu Zhuyu group and refine Xuefu Zhuyu group in improvement of insomnia and headache were superior to the drug-pair group and placebo group. The bluish tongue and tongue with ecchymoses showed no significance.3. After the treatment, the improvement of ECG showed markedly effective in 1 case, effective in 2 cases in Xuefu Zhuyu group, markedly effective in 1 case, effective in 1 case in refine Xuefu Zhuyu group, markedly effective in 1 case, effective in 1 case in drug-pair group and effective in 1 case in placebo group. Moreover, the dosage of nitroglycerin in Xuefu Zhuyu group decreased from 3.96±1.27 pills per week to 1.15±0.58 pills per week after treatment, that of refine Xuefu Zhuyu group decreased from 3.79±0.57 pills per week to 1.54±038 pills per week after treatment, that of drug-pair group decreased from 3.50±0.61 pills per week to 1.28±0.30 pills per week after treatment, andthat of placebo group decreased from 3.79±0.77 pills per week to 2.20±0.49 pills per week after treatment. The dosage of nitroglycerin of four groups all decreased and showing statistical significance in comparing the dosages before and after treatment (P<0.01~0.05) .4. The levels of blood viscosity, platelet adhesiveness lowered and RED transfigure increased after treatment in Xuefu Zhuyu group, showing statistical significance in comparing the levels before treatment (P<0.05); The refine Xuefu Zhuyu group could reduce levels of blood viscosity, platelet adhesiveness and showing significant difference in comparing the levels before and after treatment (P<0.05); The levels of blood plasma viscosity, platelet adhesiveness lowered in drug-pair group and showing significantly difference before and after treatment (P<0.05); The levels of blood viscosity lowered and RED transfigure increased after treatment in placebo group, showing significantly difference comparing levels before and after treatment (P<0.05);5. There were no difference among levels of blood lipoprotein and ox-LDLof four groups before and after treatment (P>0.05);6. The levels of NO increased in Xuefu Zhuyu group, refine group and drug-pair group could also increase the levels of NO, showing statistical significance in comparing the levels before and after treatment (P<0.05). The levels of NO were no difference before and after treatment in placebo group. There were no differences among levels of ET of four groups before and after treatment (P>0.05). Xuefu Zhuyu groups in improvement of vascular endothelial were superior to the placebo group. The levels of t-PA increased inXuefii Zhuyu group, showing significantly difference comparing the levels before and after treatment (P<0.05). The levels of t-PA in the other groups were no difference before and after treatment (P>0.05).7. Gose correlation is also presented between numerous non-infectious diseases with inflammatory reaction, e, g; atherosclerosis is one kind of inflammatory reaction. The levels of JLr6 decreased in Xuefu Zhuyu group, refine group and drug-pair group, increased in placebo group and showing statistical significance in comparing the levels before and after treatment (P<0.05). The levels of IL-8 decreased in the four groups, showing statistical significance in comparing the levels before and after treatment in placebo group (P<0.05). Significant difference was found among four groups in increase of n^8 and decrease of IL-6 (P<0.05). The levels of Hs-CRP decreased in four groups, showing no difference among four groups before and after treatment (P>0.05).8. Before and after treatment, expressions of CD41, CD62P were detected with flow cytometry in the four groups. The Xuefu Zhuyu group and refine Xuefu Zhuyu group could reduce the expressions of CD41, CD62P, and showing statistical significance while those of drug-pair group and placebo group were no difference in comparing the expressions before and after treatment.9. Quality of life was evaluated by questionnaire SAQ and analyzed with SPSS in 123 cases. The scores of angina stability, angina frequency and treatment satisfaction showed significantly differences respectively in Xuefu Zhuyu group before and after treatment. The scores of angina stability, angina...