葛根素注射液联合阿托伐他汀钙治疗颈动脉粥样硬化斑块的临床研究

Clinical study on Puerarin Injection combined with atorvastatin calcium in treatment of carotid atherosclerotic plaque

目的观察葛根素注射液联合阿托伐他汀钙治疗颈动脉粥样斑块的临床疗效及其安全性,为指导临床合理用药提供参考依据。方法选取2016年1月—2017年6月河南科技大学第一附属医院收治的86例颈动脉粥样斑块患者,采用随机数表法将患者分为对照组和治疗组,每组各43例。对照组患者口服阿托伐他汀钙片,20 mg/次,1次/d。治疗组患者在对照组基础上于每个疗程前10天静脉滴注葛根素注射液,0.4 g加入5%葡萄糖500 mL,1次/d。两组患者均治疗3个月。观察两组的临床疗效,比较两组患者治疗前后总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白(LDL-C)水平,内皮素1(ET-1)、血栓素(TXB2)、一氧化氮(NO)、超敏C反应蛋白(hs CRP)水平和颈动脉中层内膜厚度(IMT)值、颈动脉内径(CAD)及斑块面积、斑块积分的变化情况。结果治疗后,对照组和治疗组的总有效率分别为72.09%和90.70%,两组比较差异具有统计学意义(P<0.05)。两组患者TC、TG和LDL-C水平均比治疗前显著降低,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗后治疗组TC、TG和LDL-C水平明显低于对照组,两组比较差异具有统计学意义(P<0.05)。两组患者ET-1、TXB2、hs CRP水平明显降低,NO水平明显升高,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗后治疗组ET-1、TXB2、hs CRP、NO水平明显优于对照组,两组比较差异具有统计学意义(P<0.05)。颈动脉斑块面积、斑块积分均明显降低,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗组患者颈动脉斑块面积、斑块积分均明显低于对照组,两组比较差异具有统计学意义(P<0.05)。结论葛根素注射液联合阿托伐他汀钙疗效显著,可有效改善颈动脉粥样斑块硬化患者的血脂及血管内皮因子水平,降低斑块积分,保护血管内皮,安全性高,具有一定的临床推广应用价值。

Objective To observe the clinical efficacy and safety of Puerarin Injection combined with atorvastatin calcium in treatment of carotid atherosclerotic plaque, so as to provide reference for clinical rational drug use. Methods Patients（86 cases） with carotid atherosclerotic plaque in the First Affiliated Hospital of Henan University of Science and Technology from January 2016 to June 2017 were randomly divided into control group and treatment groups, and each group had 43 cases. Patients in the control group were po administered with Atorvastatin Calcium Tablets, 20 mg/time, once daily. Patients in the treatment group were iv administered with Puerarin Injection on the basis of the control group, 0.4 g added into 5% Glucose Injection 500 mL, once daily. Patients in two groups were treated for 3 months. After treatment, the clinical efficacy were evaluated, the total cholesterol（TC）, triglyceride（TG）, low density lipoprotein（LDL-C） levels, endothelin 1（ET-1）, thromboxane（TXB2）, nitric oxide（NO）, high sensitive C reactive protein（hs CRP） levels, and intima-media thickness（IMT）, carotid artery diameter（CAD）, plaque area and plaque score in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups were 72.09% and 90.70%, respectively, and there were differences between two groups（P＜0.05）. TC, TG, and LDL-C levels in two groups were significantly decreased, and the difference was statistically significant in the same group（P＜0.05）. And the TC, TG, and LDL-C levels in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P＜0.05）. ET-1, TXB2, and hs CRP levels in two groups were significantly decreased, but NO level were significantly increased, and the difference was statistically significant in the same group（P＜0.05）. And those levels in the treatment group were significantly better than those in the control group, with significant difference between two groups（P＜0.05）. Plaque area and plaque score in two groups were significantly decreased, and the difference was statistically significant in the same group（P＜0.05）. And those indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P＜0.05）. Conclusion Puerarin Injection combined with atorvastatin calcium has good effect in treatment of carotid atherosclerotic plaque, can effectively improve the blood lipid and vascular endothelial growth factor levels, reduce plaque and protect endothelial cells, with good safety, which has a certain clinical application value.