| Objective:The preliminary assessment of Kuanxin capsule treatment's efficacy and safety to the coronary heart disease, angina (Qi-stagnancy and Blood-stasis Syndrome), and explore the most safe and effective dosage.Methods:1. With the comparison of Guanxin salvia miltiorrhiza capsule and placebo, using a randomized, double simulation clinical experiment method to divide 64 patients who are meet the condition into 4 groups, each group has 16 patients. These patients have no different on the aspects of sex, age, course of disease and basic diseases (P>0.05), it; has balanced comparability. The treatment group is divided into low-dosage group (simulated Kuanxin capsule, 1 grain/time,3 times/day for oral administration; Kuanxin capsule, 2 grains/time,3 times/day, for oral administration; simulated Guanxin salvia miltiorrhiza capsule,3 grains/time,3 times/day for oral administration) high-dosage group (Kuanxin capsule,1 grain/time,3times/day, for oral administration, Kuanxin capsule, 2 grains/time,3 times/day for oral administration, simulated Guanxin salvia miltiorrhiza capsule,3 grains/time,3times/day for oral administration).. The control group is divided into positive control group (simulated Kuanxin capsule,1 grain/time,3 times/day for oral administration, simulated Kuanxin capsule,2 grains/times, 3 times/day for oral administration, Guanxin salvia miltiorrhiza capsule,3 grains/time,3 times/day for oral administration). And placebo group (simulated Kuanxin capsule,1 grain/time,3 times/day for oral administration, stimulated Kuanxin capsule,2 grains/time, 3 times/day for oral administration, simulated Guanxin salvia miltiorrhiza capsule,3 grains/time,3 times/day for oral administration). The course of treatment is six weeks.2. Observing its angina pectoris, Chinese traditional medical syndrome, the total effective rate and nitroglycerin stop reduction, making statistics processing, and comparing its curative effect.3. Laboratory checking the blood routine and urine and dung routine+occult blood, blood fat (TC and TG, HDL-c, LDL-C) liver and kidney's function (ALT, AST, BUN, Cr), and four items of clotting (TT, PT, APTT, FIB) fasting glucose as safety index in order to explore the safety and the best effective dose of Kuanxin capsule.4. Observing the change of electrocardiogram (ECG),and activity exercise treadmill testing (ETT) before and after the treatment.5. x±S explains measurement data, using t-test to analyze, Counting material using X2 inspection, all data analysis by SPSS processing.Results:1. The comparison of four groups'angina symptoms before and after the treatment (Table 5)The result shows that the difference between the low and high-dosage group and positive control group before and after the treatment has remarkable significance (P<0.05). The difference between low, high-dosage groups and positive control group after the treatment has no significant (P>0.05). No significant differences between before and after the placebo treatment. (P> 0.05). The difference between low and high-dosage group, positive control group and placebo group after treatment has notable significance. (P<0.05).2 The comparison of angina symptom's efficacy (Table 6)The result shows that the low-dosage group, positive control group' s total effective rate is 87.5% after the treatment. The total effective rate of high-dosage group's angina curative effect is 93.75%. The angina symptom of high-dosage group is better than low-dosage group. The comparison of low and high-dosage group, positive control group and angina symptom' s efficacy after placebo treatment has remarkably significance (P<0.05). The angina pectoris's curative effect of low and high-dosage group, positive control group after the treatment has no significant difference. (P >0.05).3. The comparison of Chinese traditional medical syndrome curative effect (Table 7)The result shows that the comparison of the high-dosage group and the positive control group' s TCM syndrome curative effect after the treatment has no significant difference. (P>0.05)4. The comparison of nitroglycerin stop and reduce curative effect (Table 8) The result shows that after the low-dosage group, positive control group' s treatment, nitroglycerin total stop reduced rate is 87.5; After the high-dosage group' s treatment, nitroglycerin total stop reduced rate is 93.75%.After the low and high-dosage group, positive control group's treatment, the difference between nitroglycerin stop reduced efficacy of the three groups has no statistical significance (P>0.05), It has comparability, Compared with placebo, nitroglycerin stop reduced efficacy is better than the placebo group,the difference between them has notable meaning. (P< 0.05).5. The comparison of electrocardiogram efficacy. (Table 9)The result shows that the difference between electrocardiogram efficacy of the low and high-dosage group, positive control group after treatment has no statistical significance (P> 0.05).It has comparabil ity. The comparison of electrocardiogram curative effect after low and high-dosage group, positive control group treatment and the placebo treatment has notable meaning. (P< 0.05).6 The comparison of sports load electrocardiogram (Table 10)The result shows that the difference between sports load electrocardiogram efficacy of the low and high-dosage group, positive control group after treatment has no statistical meaning. (P>0.05),.It has comparability. Compared with placebo, the sports load electrocardiogram curative effect after treatment has significant difference (P<0.05).7 Clinical subjects has no obvious adverse reactions, general physical examination, blood, routine urine test+occult blood, liver function, kidney function, and clotting four, blood glucose testing have no anomaly. The result suggests that it is safe to use kuanxin capsule to cure coronary disease and angina pectoris.8 After the treatment to the low-dosage group and the high-dosage group, the comparison of angina symptoms curative effect, nitroglycerin stop minus curative effect, electrocardiogram curative effect, sports load electrocardiogram curative effect shows that high-dosage group is higher than the low-dosage group. i.e. There is a dose-effect relationship in the treatment of kuanxin capsule.Conclusion:1 Kuanxin capsule can cure coronary heart disease; angina (Qi-stagnancy and Blood-stasis Syndrome). In the aspect of angina symptoms, syndromes, nitroglycerin stop minus curative effect, electrocardiogram curative effect, sports load electrocardiogram' s curative effect, there is no different with Guanxin salvia miltiorrhiza capsule and it has comparability. High-dosage group is higher than the low-dosage group and positive control group.2 TCM treatment of promoting qi circulation to relieve pain and activating blood circulation to dissipate blood stasis has general meaning in curing coronary heart disease and angina pectoris. It is worth to clinical spread.3 The comparison of curative effect of kuanxin capsule's high-dosage groups and low-dosage shows that high-dosage group is higher than that of low-dosage group, i.e. There is a dose-effect relationship in the treatment of kuanxin capsule. |
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