缬丹心泰片治疗冠心病心绞痛的临床研究

目的]对缬丹心泰片治疗冠心病心绞痛(气滞血瘀证)的疗效及安全性作出评价.方法]根据患者的病情及一般情况,采用随机分组、双盲双模拟、阳性药平行对照、多中心临床研究方法,治疗组145例口服缬丹心泰片,分为小剂量组72例(3片/次,2次/d)和大剂量组73例(3片/次,3次/d),对照组75例口服复方丹参片,3片/次,3次/d.4周后进行心绞痛、心电图、中医证候等方面的疗效及安全性评估.结果]心绞痛疗效、中医证候疗效治疗组与对照组间无显著性差异,小剂量治疗组的心电图有效率为66.67%,大剂量治疗组为68.49%,显著优于对照组49.33%(P<0.05).结论]缬丹心泰片治疗冠心病心绞痛具有一定的疗效,且未见毒副作用.

Clinical research on Xiedanxintai Tablet in treating angina caused by coronary heart disease

Objective] To observe the curative effect of Xiedanxintai tablet in treating angina pectoris caused by coronary heart disease(CHD and stagnation of QI and stasis of blood in TCM) and evaluate its safety. Methods] According to the disease severity and the general condition of the patients they were divided randomly into several groups and a research method of doubleblind, doublemimesis, positive medicine control and multicenters was adopted. One hundred and forty five patients in treatment group was administrated with Xiedanxintai tablet. among them 72 cases were given with lowdose (three tablets, twice a day) and 73 cases with high dose (three tablets, three times a day). Seventy five patients were served as control giving orally complex salvia miltiorrhiza tablets (three tablets, three times a day). Four weeks later, the severity of angina pectoris, ECG, main symptoms of TCMetc. were collected and analyzed. Results] There was no significant deference in improving Angina pectoris and the symptoms in TCM between Xiedanxintai tablet group and control. The effective rate in ECG improvement in the lowdose group was 66.67% and 68.49% in the high dose group. All of themwere more effective than that of the control group (49.33%, P<0.05). Conclusion] Xiedanxintai tablet is effective at a certain degree in treatingangina pectoris caused by CHD and hasn't side and toxic action.