桂枝茯苓胶囊治疗颈动脉粥样硬化的临床研究

Clinical research of Guizhi Fuling Capsule in the treatment of patients with carotid atherosclerosis

目的观察桂枝茯苓胶囊对颈动脉粥样硬化的临床疗效。方法选择2011年3月至2012年6月在我科就诊的138例颈动脉粥样硬化患者为研究对象,均经颈动脉超声证实其颈动脉内膜-中层有增厚和/或斑块形成。随机分为三组,治疗组50例,口服桂枝茯苓胶囊4粒,3次/d;西药对照组(对照1组)46例,口服阿司匹林肠溶片100mg,1次/d;中成药对照组(对照2组)42例,口服复方丹参滴丸10粒,3次/d。三组均服药6个月。分别于治疗前、治疗6个月后检测血脂、血浆内皮素(ET-1)、一氧化氮(NO)浓度的变化、血小板CD41、CD63、CD62P表达水平的变化及用颈动脉超声检测患者的双侧颈动脉内膜中层厚度(IMT)、斑块形态等指标。结果①治疗前后三组间血脂、ET、NO浓度差异无统计学意义(均P>0.05);②桂枝茯苓胶囊组治疗后CD41、CD63、CD62P测定值均低于治疗前水平(均P<0.05),而对照1组及对照2组治疗前后结果差异均无统计学意义(P>0.05);③桂枝茯苓胶囊组颈动脉IMT、不稳定斑块的个数、面积的改善均明显优于对照1组和对照2组(P<0.05);④桂枝茯苓胶囊组未发现有严重不良反应。结论桂枝茯苓胶囊具有减少颈动脉不稳定斑块个数、缩小斑块面积、降低IMT及抗血小板活性作用。

Objective To observe the effects of Guizhi Fuling Capsule in the treatment of patients with carotid atherosclerosis （CAS）.Methods One hundred and thirty-eight CAS patients with carotid intima-media thickening and/or plaque formation confirmed by ultrasonic from March 2011 to June 2012 were involved in this study.The patients were randomly divided into three groups：the treatment group （50 cases,treated with Guizhi Fuling Capsule 3 times daily,4 granules for each time）,the western medicine control group （the control group 1,46 cases,treated with aspirin enteric-coated tablets 100 mg,once daily）,and the Chinese medicine control group （the control group 2,42 cases,treated with compound Danshen Dripping Pill 3 times daily,10 pills for each time）.All groups were treated for 6 months.The concentration of serum lipids,plasma endothelin （ET-1） and nitric oxide （NO）,the changes of Platelet CD41,CD63,CD62P,the changes of bilateral carotid artery intima-media thickness （IMT）,plaque morphology before treatment and 6 months after treatment were detected respectively.Results ① No significant difference was found in serum lipids,ET,NO concentration between the three groups before treatment and after treatment （P＞0.05）.② CD41,CD63,CD62P levels in the treatment group after treatment were significantly lower than those before treatment （P＜0.05）,while no significant difference were found in both control group 1 and control group 2 （P＞0.05）.③ IMT,unstable plaque and plaque area in the treatment group were significantly better than those in the control group 1 and control group 2 （P＜0.05）.④No serious adverse reactions were found in the treatment group group.Conclusion Guizhi Fuling Capsule could reduce the number of unstable plaque in the carotid artery and its area,decrease IMT,and improve endothelial function and anti-platelet activity in patients with CAS.