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中国临床药理学与治疗学 ›› 2004, Vol. 9 ›› Issue (9): 1033-1036.

• 研究原著 • 上一篇    下一篇

心达康胶囊治疗冠心病心绞痛(胸痹心血瘀阻证)临床研究

向楠, 胡有志, 石杰, 张峰, 冯德勋, 邓阿黎   

  1. 湖北中医学院附属医院内科, 武汉430061, 湖北
  • 收稿日期:2004-06-23 修回日期:2004-08-26 出版日期:2004-09-26 发布日期:2020-11-23
  • 通讯作者: 向楠, 女, 教授, 博士生导师, 研究方向中西医结合治疗心脑血管病。Tel:027-88928115 E-mail:xiangnan612000 @yahoo. com. cn

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

XIANG Nan, HU You-Zhi, SHI Jie, ZHANG Feng, FENG De-Xun   

  1. Department of Internal Medicine, the Affiliated Hospital, Hubei College of Traditional Chinese Medicine, Wuhan 430061, Hubei, China
  • Received:2004-06-23 Revised:2004-08-26 Online:2004-09-26 Published:2020-11-23

摘要: 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. 01)。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60. 0 %, 能明显减少心电图ΣST 、NST 、NT(P<0. 01)。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. 01)、纤维蛋白原有所下降(P >0. 05)。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。

关键词: 心达康胶囊, 心绞痛, 中药疗法, 药物不良反应, 临床试验

Abstract: 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.

Key words: xindakang capsule, angina pectoris, TCD therapy, adverse drug reaction, clinical trail

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