瑞舒伐他汀联合普罗布考治疗颈动脉易损粥样硬化斑块的疗效临床随机对照研究

Clinical Research of Rosuvastatin Combined with Probucol on Patients with Vulnerable Carotid Atherosclerosis Plaque

目的观察瑞舒伐他汀联合普罗布考治疗颈动脉易损粥样硬化斑块的临床疗效。方法选取2010年1月—2011年10月北京同仁医院收治的颈动脉易损粥样硬化斑块患者160例,将其随机分为对照组(口服瑞舒伐他汀片10 mg/次,1次/d)和研究组(口服瑞舒伐他汀片10 mg/次,1次/d;普罗布考片500 mg/次,2次/d),各80例,均治疗12个月。观察两组患者治疗前及治疗6个月、12个月后颈动脉内膜中层厚度(IMT)、颈动脉内膜斑块面积、易损斑块检出率以及血脂〔总胆固醇(TC)、三酰甘油(TG)、高密度脂蛋白胆固醇(HDL-C)和低密度脂蛋白胆固醇(LDL-C)〕水平的变化,并比较不良反应发生率。结果治疗前两组患者颈动脉IMT、颈动脉内膜斑块面积、血脂水平比较,差异均无统计学意义(P>0.05);而治疗6个月后研究组患者颈动脉内膜斑块面积、易损斑块检出率及TC、LDL-C水平均低于对照组,治疗12个月后研究组患者颈动脉IMT、颈动脉内膜斑块面积、易损斑块检出率及TC、LDL-C水平均低于对照组,差异有统计学意义(P<0.05)。对照组和研究组患者脑梗死发生率分别为5.0%(4/80)和1.2%(1/80),差异无统计学意义(P=0.367)。治疗12个月内,两组患者各种不良反应发生率间差异无统计学意义(P>0.05)。9例新发糖尿病患者脑梗死发生率为11.1%(1/9),未发生糖尿病的患者脑梗死发生率为2.6%(4/151),差异无统计学意义(P=0.254)。结论瑞舒伐他汀联合普罗布考治疗颈动脉易损粥样斑块的疗效优于单纯瑞舒伐他汀治疗,可以快速降低TC、LDL-C水平和逆转斑块。

Objective To study the effect of rosuvastatin combined with probucol on patients with vulnerable carotid atherosclerosis plaque. Methods 160 patients with vulnerable carotid atherosclerosis plaque admitted to Beijing Tongren Hospital from January 2010 to October 2011 were randomly divided into control group （treated with rosuvastatin per os, 10 mg once daily） and research group （treated with rosuvastatin per os, 10 mg once daily combined with probucol, 500 mg twice daily）, with each group 80 cases. The two groups were both treated for 12 months. The intima - media thickness （ IMT）, plaque area of carot- id artery, the number of vulnerable carotid atherosclerosis plaque, the change of blood total cholesterol （TC）, triglyceride （TG）, high- density lipoprotein cholesterol （HDL- C） and low- density lipoprotein cholesterol （LDL- C） were monitored and detected in all patients before and after treatment at 6 and 12 months. The rates of the adverse reactions in two group patients were compared. Results Before treatment, the IMT, plaque area of carotid artery and blood lipids between the two groups showed no statistically significant difference （P 〉 0. 05） . After six months treatment, the plaque area of carotid artery, propor- tion of vulnerable carotid atherosclerosis plaque, TC and LDL - C in the research group were significantly lower than the control group （P 〈 0. 05） . After 12 months treatment, the IMT, plaque area of carotid artery, proportion of vulnerable carotid athero-sclerosis plaque, TC and LDL - C in the research group were significantly lower than the control group （ P 〈 0. 05 ） . The inci- dence of cerebral infarction was 5.0% （4/80） and 1.2% （1/80） in the two groups, showing no statistically significant differ- ence （P = 0. 567） . During the 12 months treatment, the adverse reactions between the two groups showed no statistically signifi- cant difference （P 〉 0. 05） . The nine patients with new -onset diabetes had a cerebral infarction incidence of 11.1% （1/9） , while patients without diabetes had a cerebral infarction incidence of 2. 6% （4/151）, showing no statistically significant differ- ence （ P =0. 254） . Conclusion Rosuvastatin combined with probucol is more effective than rosuvastatin alone on patients with vulnerable carotid atherosclerosis plaque, and can reduce TC, LDL- C levels and plaque numbers.