血塞通滴丸治疗冠心病心绞痛(心血瘀阻证)的临床研究

目的评价血塞通滴丸治疗冠心病心绞痛(心血瘀阻证)的临床疗效与安全性。方法以血塞通片为对照,进行随机、双盲双模拟、阳性药平行对照、多中心临床试验。结果血塞通滴丸对冠心病心绞痛总有效率为82.1%,对心电图总有效率为67.2%,能明显改善冠心病心绞痛(心血瘀阻证)的各种症状,对中医症状的总有效率为86.6%,在治疗1周后,对中医证候和中医证候总积分的改善优于对照组(P<0.01),随着疗程的延长组间差异逐渐缩小,治疗4周后,对中医症状和中医证候总积分的改善差异无统计学意义(P>0.05);血塞通滴丸的起效时间缩短,起效迅速,明显优于对照组(P<0.01);两组未见明显不良反应,一般体检项目,血、尿、粪常规,肝、肾功能试验前正常者试验后无异常。结论血塞通滴丸治疗冠心病心绞痛(心血瘀阻证)安全、有效、起效时间快。

Efficacy and safety of xuesetong pills in the treatment of patients with angina pectoris

AIM: To evaluate the efficacy and safety of xuesetong pills in the treatment of patients with angina pectoris. METHODS: Regard xuesetong tablet as contrast, xuesetong pill was observed in a random, double blind, double modeling, positive drug parallel contrast and multi center clinical trial. RESULTS: The total effective rate of xuesetong pill was 82.1 % on angina pectoris and 67.2 % on the amelioration of ECG, and there was no significant difference on the symptoms and ECG between the two groups (P> 0.05 ). Xuesetong pill can significantly relieve the symptoms of angina pectoris, and the total effective rate of xuesetong pill was 86.6 % on the symptoms of the traditional Chinese medicine. Comparing with the xuesetong tablet, xuesetong pill can markedly relieve the symptoms of the traditional Chinese medicine after the treatment of xuesetong pills for 1 week, and there was a significant difference on the symptoms of the traditional Chinese medicine and the amount of the symptoms of the traditional Chinese medicine between the two groups (P< 0.01 ). But there was no marked difference after the treatment of xuesetong pills for 4 weeks (P> 0.05 ). The blow result time of xuesetong pill is superior to that of the xuesetong tablet (P< 0.01 ). No serious side effects on general health exam, blood routine, urine routine, stool routine, liver function and kidney function were observed in the two groups. CONCLUSION: Xuesetong pill has a characteristic of safe, effective, fast result blowing in the treatment of angina pectoris.