【摘要】 目的观察稳消方对颈动脉粥样硬化不稳定斑块的干预作用。方法选择2003年7月~2014年1月符合入选标准的78例患者,分别来自上海市第六人民医院、上海普陀区中心医院、上海市第八人民医院、上海奉贤区中心医院门诊及病房,采用随机数字表将其随机分为两组,每组39例。对照组给予基础治疗,干预组在此基础上加用稳消方。疗程为24周,研究主要终点为观察彩色多普勒超声检测颈动脉斑块数目、颈动脉内膜-中层厚度(IMT)、Crouse斑块总积分的变化,次要研究终点为观察血脂、血黏度、纤维蛋白原的变化值。结果最终全分析集(FAS)78例,符合方案集(PPS)69例。本研究中疗效判定基于PPS数据集,连续干预24周后,结果显示:两组治疗前后IMT、Crouse斑块总积分、总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)、血黏度、血细胞比容、纤维蛋白原比较,差异均有统计学意义(P<0.05),FAS统计结果与PPS结果一致;治疗后干预组IMT、Crouse总积分、TC、TG、LDL-C、全血高切黏度、全血中切黏度、全血低切黏度及纤维蛋白原水平均明显优于对照组,差异有统计学意义(P<0.05),FAS统计结果与PPS结果一致。结论稳消方可能通过改善脂质代谢、降低全血黏度及纤维蛋白原水平有效地干预颈动脉粥样硬化不稳定斑块的发生、发展,推测其有益于减少心脑血管不良事件的发生。更多还原

【Abstract】 Objective To observe the intervention effect of Wenxiao Decoction on unstable plaque of carotid atherosclerosis.Methods Seventy-eight cases of patients accorded with the inclusion criteria from July 2003 to January2014 were chosen,who were from the outpatient clinic and ward of Shanghai Sixth People’s Hospital,Putuo Central Hospital of Shanghai City,Shanghai Eighth People’s Hospital and Fengxian Central Hospital of Shanghai City,they were randomly divided into two groups according to random number table,with 39 cases in each group.The control group was given basic treatment,on basis of which,the treatment group was given Wenxiao Decoction.The course was24 weeks.The primary research endpoints were the observation of carotid plaque number,carotis intima-media thickness(IMT) and the change of Crouse plaque scores through color Doppler ultrasound.The secondary endpoints were the observation of the changes in blood lipid,blood viscosity and fibrinogen.Results Seventy-eight patients were finally included in the full analysis set(FAS) and 69 patients were included in the per protocol set(PPS).The therapeutic effect evaluating of this study was based on the PPS data set,after treatment for 24 weeks,the results revealed that:there were significant differences of IMT,Crouse total plaque scores,total cholesterol(TC),triacylglycerol(TG),low density lipoprotein cholesterin(LDL-C),blood viscosity,haematocrit,fibrinogen before and after treatment between the two groups(P<0.05),the FAS statistical results were in accordance with PPS.After treatment,the IMT,Crouse total plaque scores,TC,TG,LDL-C,whole blood high shear viscosity,whole blood middle shear viscosity,whole blood low shear viscosity and fibrinogen were all better than those of control group,the differences were statistically significant(P<0.05),the FAS statistical results were in accordance with PPS.Conclusion Wenxiao Decoction can intervene the occurrence and development of unstable plaque of carotid atherosclerosis effectively through improving lipid metabolism,decreasing whole blood viscosity and fibrinogen levels,which is predicted to be very effective in reducing the adverse events of cardiovascular and cerebrovascular diseases.更多还原