| Objective:To observe the therapeutic effects and safety of Shen Hua Capsule on stable angina pectoris (syndrome of qi stagnation and blood stasis).Metheods:In this trial 90 patients with stable angina pectoris, belonging to grade I,II of the CCS classification of coronary heart diseases and qi stagnation and blood stasis of TCM syndrome, were selected and were randomly, double-blindly and placebo-controlled divided into high dose group(n=30), low dose group(n=30) and the placebo group(n=30). All patients were administered nitroglycerin as basic treatment, and the high and low dose group received Shen Hua Capsule, while the placebo group received Shen Hua Capsule simulation agent. The whole course of treatment was 8 weeks. TCM syndrome integral, angina pectoris integral, nitroglycerin stopped reduction rate, electrocardiogram, METs, Duke score, SAQ score, and blood cell analysis, urine routine analysis, stool routine tests, liver function, kidney function, coagulation function, blood-lipid et al were recorded before and after the treatment. All data was analyzed by SPSS 19.0 statistical software.Results:1.The total effective rate of TCM syndromes:the total effective rate of TCM syndromes in the three groups was statistically significant (P<0.05).The differences between high dose group and low dose group was statistically insignificant (P’>0.0125), and compared with the placebo group, the difference of total effective rate of both low dose group and high dose group was statistically significant (P’<0.0125).2.Total effective rate of angina pectoris:the difference of the total effective rate between the three groups was statistically significant (P<0.05). The difference of the total effective rate between the high dose group and low dose group, the low dose group and the placebo group were not statistically significant (P’>0.0125); while the difference between high dose group and the placebo group was statistically significant (P’<0.0125).3.The nitroglycerin stopped reduction rate:the difference of the nitroglycerin stopped reduction rate between the three groups was statistically significant (P<0.05). The nitroglycerin stopped reduction rate of high dose group and low dose group had no difference (P>0.05). while compared with the placebo group, the difference of nitroglycerin stopped reduction rate of both low dose group and high dose group was statistically significant (P<0.05).4.The total effective rate of HCG:the total efficiency of high dose group is 43.33%. while the rate of the low dose group is 30.00%and the placebo group 23.33%, The difference was not statistically significant (P>0.05).5.The total integral of TCM syndrome, angina pectoris integral:the changes of the total integral of TCM syndrome, angina pectoris integral between the three groups after the treatment had statistical significance (P< 0.05). Compared with the placebo group, the changes of both high dose group and low dose group were statistically significant (P<0.05), and the changes between high dose group and low dose group were statistically significant (P>0.05).6.The separated TCM syndrome integral:the changes between the three groups after the treatment had statistical significance (P<0.05). Compared with placebo group, the changes of chest pain symptoms of patients in both high dose group and placebo group has statistical significance (P<0.05); Compared with placebo group, only the changes of chest tightness, palpitation symptoms in the high dose group had statistical significance (P<0.05).7.The separated angina pectoris integral:the changes of all separated angina pectoris integral between the three groups after the treatment had statistical significance (P<0.05), compared with the placebo group, the changes of angina pain degree in both high dose group and low dose group were statistically significant (P<0.05), and in terms of changes of angina attacks, duration and dosage of nitroglycerin, the difference between high dose group and placebo group had statistical significance (P<0.05).8.Metabolic equivalents:the changes of metabolic equivalents after treatment between the three groups were statistically significant (P<0.05); The difference between high dose group and low dose group, low dose group and placebo group had no statistical significance (P>0.05). Compared with the placebo group, the changes of metabolic equivalents in both high dose group and low dose group were statistically significant (P<0.05).9.Duke scores:the changes of Duke scores after treatment between the three groups were statistically significant (P<0.05); The difference between low dose group and placebo group had no statistical significance (P>0.05). Compared with the placebo group, the changes of Duke scores in high dose group were statistically significant (P<0.05).10.Seattle Life Scale score:after treatment the changes of limited physical activity levels, heart colic steady state, angina attack, awareness of disease degree between the three groups were statistically significant (P<0.05); and after treatment the changes of satisfaction rating points between the three groups had no statistical significance (P>0.05); The changes of limited physical activity levels, angina pectoris attacks and awareness of disease degree between high dose group and low dose group, low dose group and placebo group had no statistical significance (P>0.05), but the changes between high dose group and the placebo group were statistically significant (P<0.05).11.The safety results:the difference of blood, urine, stool routine, liver function, renal function, blood lipid, blood coagulation between the three groups was not statistically significant (P>0.05).Conclusion:1.Shen Hua Capsule can improve TCM syndrome and symptoms of angina pectoris of patients with stable angina pectoris of coronary heart disease (syndrome of qi stagnation and blood stasis).2.Shen Hua Capsule can improve the METs and Duke score of angina pectoris of patients with stable angina pectoris of coronary heart disease (syndrome of qi stagnation and blood stasis) in treadmill exercise test.3.Shen Hua Capsule can improve the quality of life of patients with stable angina of coronary heart disease (syndrome of qi stagnation and blood stasis). |
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