通心络胶囊对颈动脉粥样硬化不稳定斑块影响的临床研究

Clinical study of the effect of Tongxinluo capsule on carotid atherosclerotic instable plaque

目的观察通心络胶囊对颈动脉粥样硬化斑块中软斑块的干预作用。方法符合入选标准的200例患者随机分为2组,每组100例。对照组为常规治疗组,通心络治疗组在常规治疗组的基础上加用通心络胶囊3粒(1.14g),每日3次,疗程均为6个月。每3个月后2组以彩色多普勒超声检测颈动脉和椎动脉,记录斑块性质、大小和数目,并检查血糖和血脂,同时记录不良事件情况。结果(1)2组患者在性别、年龄及斑块数目体积等方面比较,差异无显著意义(P>0.05);(2)2组经治疗后在软斑块消退、软斑转为硬斑、软斑体积数目减少、无变化和恶化等方面比较,差异有显著意义(P<0.01);(3)2组治疗6个月后至1年心脑血管病事件发生比较,治疗组较对照组降低,差异有显著意义(P<0.01)。结论通心络能有效地干预颈动脉粥样硬化斑块中软斑块的发生发展并降低心脑血管疾病事件发生。

Objective To observe the effects of Tongxinluo capsule on the soft plaque in the carotid atherosclerotic plaque. Methods 200 patients according to the admissive standard were randomly divided into the treatment group and the control group, 100 cases in each group. The patients in control group were treated by routine therapy, while the patients in treatment group, based on the routine therapy, were treated by Tongxinluo capsule 1.14 g once, three times a day. with a treatment course of six months for both groups. After three months color Doppler ultrasound was used to examine the plaque＇s characteristics, sizes and number, meanwhile blood glucose and blood lipids were detected and the incidence of adverse events were recorded. Results （ 1 ） There was no significant difference in the risk factors of the age and sex between the two groups （ P 〉 0.05）. （2） There were significant differences in soft plaque, fading, turning into rigid plaque, decrease of volume and number between two groups （ P 〈 0.01 ）. （3）After 6 - 12 months treatment the incidence of cerebrovaseular diseases and cardiovascular diseases in treatment group was obviously reduced, as compared with that in control group, there was a significant difference between two groups （P 〈 0.01 ）. Conclusion Tongxinluo capsule could intervene effectively the development of the soft plaque in the carotid atherosclemtic plaque, and reduce the incidence of cerebrovascular diseases and cardiovascular diseases.