心达康胶囊治疗冠心病心绞痛(胸痹心血瘀阻证)临床研究

Efficacy and safety of xindakang capsules in treatment of patients with angina pectoris

目的 :评价心达康胶囊治疗冠心病心绞痛 (胸痹心血瘀阻证 )的临床疗效与安全性。方法 :以地奥心血康胶囊为对照 ,进行随机、阳性药对照的多中心临床试验。结果 :心达康胶囊缓解冠心病心绞痛症状疗效为 84 .4 % ,能显著减少心绞痛的发作次数、持续时间及程度和硝酸甘油的用量 (P <0 .0 1)。中医症侯疗效的总有效率达 85 .6 % ,治疗后各单项中医症状均有不同程度改善 ,其中尤以胸闷痛 (有效率88.9% )、心悸 (有效率 84 .8% )症状改善较明显。心达康胶囊心电图总有效率为 6 0 .0 % ,能明显减少心电图∑ST、NST、NT(P <0 .0 1)。心达康胶囊改善血液流变学指标 ,治疗后患者的全血粘度 (高切、低切 )、血浆粘度、红细胞压积均明显降低 (P <0 .0 1)、纤维蛋白原有所下降 (P >0 .0 5 )。两组均对血、尿、粪常规、肝、肾功能无不良影响 ,未见明显不良反应。结论 :心达康胶囊治疗冠心病心绞痛 (胸痹心血瘀阻证 )安全、有效。

AIM:To evaluate the efficacy and safety of xindakang capsules in the treatment of patients with angina pectoris. METHODS: Diaoxinxuekang capsule was taken as a control agent, and xindakang capsule was observed in a random, positive drug parallel contrast, multicenter clinical trail. RESULTS: Xindakang capsule significantly relieved the symptoms of angina pectoris, and reduced the number of times of attack of angina and the doses of nitroglycerin(P< 0.01). The total effective rate of xindakang capsules was 85.6% on the symptoms of the traditional Chinese medicine, such as chest pain ( 88.9%), palpitation ( 84.8%), ECG ( 60.0%). The marker of hemorheology, blood viscosity and PCV decreased(P< 0.01)in xindakang group, and the fibrinogen also decreased(P>0.05). No serious side effects were found on blood-routine, urine-routine, stool-routine, liver function and kidney function in the two groups. CONCLUSION:Xindakang capsule is an effective and safe drug in treating angina pectoris.