Objective:To evaluate the clinical efficacy and safety of TongXinLuo capsule on treating coronary heart disease with hypertension (heart blood stasis pattern)Methods:A randomized double-blind with positive control and parallel tests were carried out in 140cases. The patients were divided into two groups: Treatment group (n=66) with TongXinLuo capsule and positive control group with FuFangDanShen table(n=66), for 4 week. The Angina pectoris degree, TCM Syndrome, stop by the rate of nitroglycerin the reduction and withdrwal of administration of nitroglycerin, ECG and blood pressure were observed and analized.Results: TCM Syndrome had been improved,, the effectual rate was 13.24%, the total effective rate was 75% in treatment group, the effectual rate was 14.71%, the total effective rate was 72.57% in the control group, (PPS), the differences between two groups had no statistical difference. The attack of angina pectoris had been reduced, the differences of the therapeutic effect between two groups had no statistical difference, and Analysis conclusion of FAS was consistent with PPS. The ECG improvement had no statistical difference in two groups. The decrease rate of nitroglycerin was 37.93% in treatment group, while 52.63% in the control group. This difference between two groups had no statistical difference. All above Analysis conclusions of FAS was consistent with PPS. Effect of hypertension and classification showed, in the treatment group,12 cases were markedly effective,17 cases were effective; in the control group,63cases were markedly effective,21 cases were effective, but the differences between two groups had no statistical difference. In the patients with mild hypertension in the treatment group (n=38),5 cases were markedly effective,11 cases were effective; in the control group(n=34),2 cases were markedly effective,11 cases were effective, but the differences between two groups had no statistical difference. In the patients with moderate hypertension in the treatment group (n=22),4 cases were markedly effective,4 cases were effective; in the control group(n=34),5 cases were markedly effective,7 cases were effective, but the differences between two groups had no statistical difference. Analysis conclusion of FAS was consistent with PPS. Ambulatory blood pressure(ABP), difference between The highest systolic blood pressure before and after medication in 24 hours had markly statistical difference. The decline extent in the treatment group was higher than that in the control group. And in the treatment group, the highest systolic blood pressure before and after medication had markly statistical difference. The remaining items about blood-pressure had no statistical difference. No serious adverse reactions were observed in using tongxinluo capsule.Conclusion:tongxinluo capsule has good effect on treating the coronary heart disease with hypertension (stagnation of heart-blood syndrom) especially on decrease of systolic blood which is better than fufangdanshen table, and it is safe in clinical using. |