阿托伐他汀钙片治疗脑卒中并脑微出血的临床研究

Clinical trial of atorvastatin calcium tablets in the treatment of stroke with cerebral microbleeds

目的观察阿托伐他汀钙联合苯磺酸氯氨地平和美托洛尔治疗脑卒中并脑微出血的临床疗效及安全性。方法将80例脑卒中并脑微出血患者随机分为对照组40例与试验组40例。对照组予以每日晨起口服苯磺酸氯氨地平每次5 mg qd+口服琥珀酸美托洛尔缓释片每次47.5 mg qd;试验组在对照组治疗的基础上,予以每日睡前口服阿托伐他汀钙每次20 mg qd。2组患者均治疗6个月。比较2组患者的临床疗效、脑微出血灶数目、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、一氧化氮(NO)、肱动脉血流介导血管舒张功能(FMD)、肱踝动脉脉搏波传导速度(ba PMV)及收缩压(SBP)、舒张压(DBP),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为87.50%(35/40例)和67.50%(27/40例),差异有统计学意义(P<0.05)。治疗前和治疗后2周、治疗后6个月,试验组的脑微出血数目分别为(4.14±0.96),(2.82±0.73),(1.70±0.51)个,对照组的脑微出血数目分别为(4.14±1.01),(2.97±0.75),(2.41±0.66)个,治疗后与治疗前组内比较差异均有统计学意义(P<0.05),治疗后6个月组间比较差异有统计学意义(P<0.05)。治疗后6个月,试验组和对照组的TC分别为(1.98±0.98),(2.71±0.43)mmol·L^(-1);LDL-C分别为(0.87±0.15),(1.50±0.24)mmol·L^(-1);ba PMV分别为(1418.18±40.26),(1519.47±51.66)cm·s^(- 1);SBP分别为(112.26±18.01),(122.34±19.58)mm Hg;DBP分别为(66.11±10.64),(73.70±11.80)mm Hg;NO分别为(79.99±12.84),(70.19±11.25)μmol·L^(-1);FMD分别为(9.99±1.60)%,(9.00±1.44)%,差异均有统计学意义(P<0.05)。试验组和对照组的脑出血发生率分别为2.50%,7.50%;血栓发生率分别为0,5.00%;脑梗死发生率分别为2.50%,10.00%;肝肾功能损伤发生率为2.50%,0,差异均无统计学意义(P>0.05)。结论阿托伐他汀钙联合苯磺酸氯氨地平和美托洛尔治疗脑卒中并脑微出血的临床疗效显著,可明显地降低患者血压,调节血管内皮功能,减少脑微出血灶数目,且不增加脑血管不良事件的发生率。

Objective To observe the clinical efficacy and safety of atorvastatin calcium combined with amlodipine besylate and metoprolol in the treatment of stroke with cerebral microbleeds. Methods Eighty stroke patients with cerebral microbleeds were randomized into control group（ n = 40 cases） and treatment group（ n = 40 cases）. Control group was given oral amlodipine besylate 5 mg qd and metoprolol succinate sustained- release tablets 47. 5 mg qd after getting up in the morning.Treatment group was treated with atorvastatin calcium 20 mg qd beforegoing to bed,on the basis of control group. Two groups were treated for 6 months. The clinical efficacy,number of cerebral microbleeds,total cholesterol（ TC）,low density lipid protein- cholesterin（ LDL- C）,nitric oxide（ NO）,brachial artery flow- mediated dilatation（ FMD）,brachial- ankle arterial pulse wave velocity（ ba PMV）,systolic blood pressure（ SBP）,diastolic blood pressure（ DBP） and the adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 87. 50%（ 35 /40 cases） and67. 50%（ 27 /40 cases）,with significant difference（ P〈0. 05）. Before treatment and after treatment 2 weeks and 6months,the number of cerebral microbleeds in treatment group were（ 4. 14 ± 0. 96）,（ 2. 82 ± 0. 73） and（ 1. 70 ± 0. 51）respectively,while in control group was（ 4. 14 ± 1. 01）,（ 2. 97 ± 0. 75） and（ 2. 41 ± 0. 66） respectively,the differences within group before and after treatment and between groups were significant（ P〈0. 05）. There was significant difference between groups at 6 months after treatment（ P〈0. 05）. After treatment 6 months,the main indexes in treatment and control groups were compared： TC were（ 1. 98 ± 0. 98）,（ 2. 71 ± 0. 43） mmol · L^-1; LDL- C were（ 0. 87 ± 0. 15）,（ 1. 50 ± 0. 24） mmol·L^-1; ba PMV were（ 1418. 18 ± 40. 26）,（ 1519. 47 ± 51. 66） cm·s^-1; SBP were（ 112. 26 ± 18. 01）,（ 122. 34 ± 19. 58） mm Hg; DBP were（ 66. 11 ± 10. 64）,（ 73. 70 ± 11. 80） mm Hg; NO were（ 79. 99 ± 12. 84）,（ 70. 19 ± 11. 25） μmol·L^-1; FMD were（ 9. 99 ± 1. 60） %,（ 9. 00 ± 1. 44） %,with statistically significant difference（ P〈0. 05）. In the treatment and control groups,the incidence of cerebral hemorrhage were2. 50% and 7. 50%; thrombosis were 0 and 5. 00%; cerebral infarction were 2. 50% and 10. 00%; liver and kidney function injury were 2. 50% and 0,without significant difference（ P〈0. 05）. Conclusion Atorvastatin calcium combined with amlodipine besylate and metoprolol has a definitive clinical efficacy in the treatment of stroke with cerebral microbleeds,which can decrease blood pressure,regulate vascular endothelial function,reduce the number of cerebral microbleeds,without increasing the incidence of cerebrovascular adverse events.