| Objective:To observe the change on patients with stable angina in exercise tolerance, angina pectoris, blood lipids, TCM syndrome effect and quality of life before and after treatment, evaluate the effect and security of Shenzhuguanxin Granules on improving exercise tolerance, relieving angina pectoris, improving the efficacy of TCM syndrome and improving the patient’s quality of life.Methods:This research adopted a double-blind randomized controlled method.88cases of stable angina according to the diagnosis criterion were randomly divided into two groups:experimental group and control group. Patients in the experimental group were administrated with conventional western medicine and Shenzhuguanxin Granules, and the dosage is two times a day and each time one bag. The control group were administrated with conventional western medicine and placebo, and the dosage is two times a day and each time one bag. The treatment lasted12weeks. To observe the change on exercise tolerance (the total time for exercise, the time of exercise-induced ST segment depression of0.1mv, the metabolic equivalents of exercise-induced ST segment depression of0.1mv, the maximum metabolic equivalents, the maximum decrease in the value of ST segment), angina pectoris, blood lipids, total effective rate of TCM syndrome effect, blood lipids (TC, TG, LDL-C, HDL-C), quality of life, and its security indexes(blood routine, liver and kidney function).Results:1.The comparison of exercise tolerance indicators:In the total exercise duration, after12weeks of treatment, two groups of patients compared with before treatment were prolonged, the difference was statistically significant (P<0.05); Comparing the experimental group with the control one, the increases in the total exercise duration had statistically significant(P<0.05), and experimental group was better than the control group. In the maximum metabolic equivalents, the experimental group was increased after12-week treatment and the difference was statistically significant (P<0.05), but the control group was not (P>0.05). There was no significant difference between the two groups after12weeks treatment (P>0.05). The increases in the maximum metabolic equivalent had a great difference between them (P<0.05). In time to1-mm ST-segment depression, two groups of patients compared with before treatment were prolonged, the difference was statistically significant (P <0.05); There was no significant difference between the two groups after12weeks treatment (P>0.05), but the increases had a great difference between them (P<0.05). In the metabolic equivalents to1-mm ST-segment depression, two groups of patients compared with before treatment were prolonged, the difference was statistically significant (P<0.05); There was no significant difference between the two groups after12weeks treatment (P>0.05), but the increases had a great difference between them (P<0.05), and experimental group was better than the control group. In the maximal ST-segment depression, the experimental group was improved after12weeks treatment (P<0.05), but the control group had no significant differences. Comparing the experimental group with the control one, the improvement had statistically significant(P <0.05). In time to target heart rate, two groups were prolonged after12weeks treatment, but the difference was not statistically significant (P<0.05). The increases between two groups had no significant differences (P>0.05). In the duration of ST depression and heart rate of the maximum metabolic equivalent, comparison between the groups before and after treatment had no significant differences, and the difference between before and after treatment also. In the number of cases of exercise-induced angina, the difference between before and after treatment had no significant differences.2. The comparison of angina pectoris:The attack frequency and duration, the degree of pain were decreased in two groups on different time points after treatment. There were also significant differences between the two groups after8weeks and12weeks treatment in the attack frequency and duration(P <0.05), and the experimental group is better than the control group. After12weeks treatment, two groups had significant differences in the degree of pain (P<0.05). The nitroglycerin consumption was decreased after treatment in the experimental group (P<0.05), and there were significant difference between the two groups after8weeks and12weeks treatment. The comparition of CCS angina classification between the two groups has significant differences, and the experimental group improved more obviously.3. The comparison of the efficacy of TCM syndrome:The TCM syndrome scores in two groups were decreased on different time point after treatment, there were significant differences between the two groups. The efficacy of TCM syndrome in two groups on different time point has significant differences (P<0.05), The total efficiency of TCM syndrome in the experimental group after12-week treatment was86%, the control group was43.9%.4. The comparison of the efficacy on individual TCM symptoms:The individual syndrome of chest tightness, fatigue, short of breath and spontaneous sweating were improved in two groups on different time points after treatment (P<0.05), the improvement in the experimental group was better than the control group.5. The comparison of quality of life:At different time point, the two groups in the quality of life was improved. The experimental group was superior to the control group in improving PL, AS, AF and TS scores (P<0.05).6. The comparison of blood lipids:TC were reduced in two groups of patients who took lipid-lowering drugs after12weeks of treatment (P<0.05), the decreases had statistically significant between the two groups. LDL-C was reduced in two groups after treatment (P<0.05), the decreases had no statistically significant (P>0.05).7. Security Comparison:In two groups there were not any serious adverse reaction before and after treatment. The blood routine, liver and kidney function had no significant differences (P>0.05).Conclusion:The study indicates that Shenzhuguanxin Granules can improve exercise tolerance of patients with stable angina, prolong the total exercise duration and improve cardiac reserve capacity, then improve prognosis; increase the maximum metabolic equivalents, improve the exercise endurance and increase the amount of work; and it can prolong time to1-mm ST-segment depression, strengthen the anti-anoxia ability; It can increase the metabolic equivalents to1-mm ST-segment depression, improve myocardial ischemic threshold; improve the maximal ST-segment depression, and has the function of anti-myocardial ischemia. It can alleviate angina pectoris, reduce the consumption of nitroglycerin, reduce LDL-C level, and has certain effect on regulating blood lipids. Regulating spleen and treating heart method can significantly improve the efficacy of TCM syndrome and improve the individual syndrome of chest tightness, fatigue, short of breath and spontaneous sweating; It can improve the quality of life in patients with stable angina. It may have some regulation of lipid metabolism. No significant side effect was found during the observation, and it has high security, worthing further promote the use of clinical. |
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