复方丹参滴丸对颈动脉粥样硬化斑块的消退作用:多中心随机对照实验

背景大量基础研究表明,复方丹参滴丸对颈动脉粥样硬化斑块有一定的消退作用,但缺乏随机对照、多中心、大样本的临床实验数据.目的观察复方丹参滴丸对颈动脉粥样硬化斑块的消退作用,并与阿司匹林作用相比较.设计多中心,随机对照实验.单位解放军第四军医大学西京医院中医药研究中心和超声科,西安交通大学第二临床医院中医科,西安市中医医院心脏内科.对象选择2002/2004解放军第四军医大学中医药研究中心门诊、西安交通大学第二附属医院中医科、西安市中医医院心脏内科就诊的年龄40～80岁,颈动脉内中膜厚度≥1.2 mm的患者162例,随机分为两组丹参滴丸组89例(软斑、硬斑患者分别为49,40例),阿司匹林组73例(软斑、硬斑患者分别为42,31例).方法丹参滴丸组口服复方丹参滴丸(10粒/次,3次/d),阿司匹林组口服肠溶阿司匹林片(75 mg/次,1次/d),连续服用6个月.治疗前后利用高分辨力B型超声检测颈动脉内中膜厚度的改变.主要结局观察治疗前后患者颈动脉内中膜厚度变化.结果按实际处理分析,共有143例患者完成6个月治疗,进入结果分析.①软斑患者颈动脉内中膜厚度测值丹参滴丸组患者治疗后较治疗前明显下降(2.12±0.34),(2.44±0.40)mm,t=4.267,P＜0.01];阿司匹林组患者治疗后也较治疗前下降(2.25±0.3),(2.41±0.38)mm,t=0.583,P＜0.05].②硬斑患者颈动脉内中膜厚度测值无论丹参滴丸组还是阿司匹林组治疗前后均无显著变化丹参滴丸组(2.46±0.42),(2.34±0.40)mm,阿司匹林组(2.42±0.44),(2.36±0.38)mm,P＞0.05].结论复方丹参滴丸具有使动脉粥样硬化软斑消退的作用,其效果与阿司匹林相似.

Removing action of compound danshen di wan on carotid atherosclerotic plaques: Multi-central randomized controlled experiment

BACKGROUND: It is indicated in a large amount of basic researches that compound danshen di wan has a certain action on removing carotid atherosclerotic plaques (CAP), but there is lack of large sample data in randomized, controlled, multi-central clinical experiment.OBJECTIVE: To observe the removing action of compound danshen di wan on CAP, compared with aspirin.DESIGN: Multi-central, randomized controlled experiment was designed.SETTING: Research Center of Traditional Chinese Medicine and Ultrasonic Department of Xinjing Hospital, Fourth Military Medical University of Chinese PLA; Department of Traditional Chinese Medicine of Second Clinical Hospital, Xi' an Jiaotong University and Department of Cardiac Internal Medicine of Xi' an Hospital of Traditional Chinese Medicine.PARTICIPANTS: Totally 162 cases were selected from the clinic of Research Center of Traditional Chinese Medicine, Fourth Military Medical University of Chinese PLA; Department of Traditional Chinese Medicine, Second Clinical Hospital, Xi' an Jiaotong University and Department of Cardiac Internal Medicine of Xi' an Hospital of Traditional Chinese Medicine from 2002 to 2004, aged varied from 40 to 80 years, the thickness of carotid internal media ≥ 1.2 mm. They were randomized into two groups, named danshen di wan group of 89 cases(cases of soft plaque and hard plaque were 49 and 40 respectively) and aspirin group of 73 cases(cases of soft plaque and hard plaque were 42 and 31 respectively).METHODS: In danshen di wan group: compound danshen di wan was administrated orally(10 pills/time, 3 times/day), in aspirin group, enteric soluble aspirin table was administrated orally(75 mg/time, once a day),continuously for 6 months. The alternations of thickness of carotid internal media were determined with ultrasonic B of high resolving power before and after treatment.MAIN OUTCOME MEASURES: Changes in thickness of carotid internal media before and after treatment.RESULTS: By practical measuring analysis, 143 cases accomplished nation of thickness of carotid internal media in the patients with soft plaque:In danshen di wan group, the thickness was remarkably decreased after treatment (2. 12 ± 0. 34), (2.44± 0.40) mm, t = 4. 267, P ＜ 0.01 ] . In aspirin group, it was also reduced relatively after treatment (2.25 ± 0. 3),of carotid internal media in the patients with hard plaque: The changes were not significant no matter in danshen di wan group or aspirin group in the comparison before and after treatmentin danshen di wan group: (2.46 ±0.42),(2.34 ± 0. 40) mm; in aspirin group: (2.42 ± 0. 44), (2. 36 ± 0. 38) mm,P＞ 0.05].CONCLUSION: Compound danshen di wan acts on removing soft atherosclerotic plaque and its effect is similar to aspirin.