依折麦布片联合辛伐他汀片治疗动脉粥样硬化伴高胆固醇血症的临床研究

Clinical trial of ezetimibe tablets combined with simvastatin tablets in the treatment of patients with atherosclerosis associated with hypercholesterolemia

目的观察依折麦布片联合辛伐他汀片治疗动脉粥样硬化伴高胆固醇血症的临床疗效及安全性。方法将102例动脉粥样硬化伴高胆固醇血症患者随机分为对照组52例和试验组50例。对照组予以辛伐他汀片每次10 mg,qd,口服;试验组在对照组治疗的基础上,予以依折麦布片每次5 mg,qd,口服。2组患者均治疗8周。比较2组患者的临床疗效、血脂水平,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96.00%(48例/50例)和78.85%(41例/52例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的总胆固醇分别为(4.27±0.56)和(5.28±0.75)mmol·L^(-1),三酰甘油分别为(1.38±0.11)和(1.98±0.15)mmol·L^(-1),低密度脂蛋白胆固醇分别为(2.67±0.39)和(3.20±0.55)mmol·L^(-1),差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以肌肉毒性和转氨酶异常为主,试验组和对照组的总药物不良反应发生率分别为14.00%和15.38%,差异无统计学意义(P>0.05)。结论依折麦布片联合辛伐他汀片治疗动脉粥样硬化伴高胆固醇血症的临床疗效显著优于单用辛伐他汀片,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of ezetimibe tablets combined with simvastatin tablets in the treatment of patients with atherosclerosis associated with hypercholesterolemia. Methods A total of 102 patients with atherosclerosis associated with hypercholesterolemia were randomly divided into control group（ n = 52 cases） and treatment group（ n = 50 cases）. Control group was given simvastatin per time 10 mg,qd,orally. Treatment group received ezetimibe per time 5 mg,qd,orally,on the basis of control group. Two groups were treated for 8 weeks. The clinical efficacy,the levels of blood lipid and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 96. 00%（ 48 cases/50 cases） and 78. 85%（ 41 cases/52 cases） with significant difference（ P〈0. 05）. After treatment,the main indexes of treatment and control groups were compared： total cholesterol were（ 4. 27 ± 0. 56） and（ 5. 28 ± 0. 75） mmol · L^-1,triglyceride were（ 1. 38 ± 0. 11） and（ 1. 98 ± 0. 15） mmol·L^-1,low density lipoprotein cholesterol were（ 2. 67 ± 0. 39） and（ 3. 20 ± 0. 55） mmol · L^-1,the differences were statistically significant（ all P〈0. 05）. The adverse drug reactions of two groups were muscle toxicity and transaminase abnormality. The total incidences of adverse drug reactions in treatment and control groups were 14. 00% and 15. 38% without significant difference（ P〈0. 05）. Conclusion Ezetimibe tablets combined with simvastatin tablets have a definitive clinical efficacy in the treatment of patients with atherosclerosis associated with hypercholesterolemia,without increasing the incidence of adverse drug reactions.