依折麦布联合瑞舒伐他汀治疗2型糖尿病合并高脂血症患者的临床研究

Clinical trial of ezetimibe combined with rosuvastatin in the treatment of patients with type 2 diabetes mellitus and hyperlipidemia

目的观察依折麦布联合瑞舒伐他汀对2型糖尿病合并高脂血症患者的临床疗效及安全性。方法将124例2型糖尿病合并高脂血症患者随机分为对照组和试验组,每组62例。对照组给予瑞舒伐他汀钙片治疗,初始剂量为5 mg,每日1次,根据血脂控制情况调整剂量。试验组在对照组的基础上给予依折麦布10 mg,口服,每日1次。2组均连续治疗3个月。比较2组患者的空腹血糖、脂肪细胞因子水平,并统计2组临床治疗总有效率和药物不良反应发生情况。结果治疗后,试验组和对照组的总有效率分别为91.94%(57例/62例)和79.03(49例/62例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组空腹血糖(FBG)分别为(6.21±0.34)和(6.42±0.37)mmol·L^(-1),糖化血红蛋白(HbA1c)分别为(6.37±0.52)%和(7.14±0.57)%,脂联素(ADPN)分别为(19.85±2.34)和(14.98±1.62)μg·mL^(-1),内脂素(Visfatin)分别为(48.98±5.07)和(42.66±4.69)μg·mL^(-1),丝氨酸蛋白酶抑制剂(Vaspin)分别为(3.36±0.89)和(4.52±1.21)μg·mL^(-1),趋化素(Chemerin)分别为(82.11±15.98)和(98.66±21.71)ng·mL^(-1),差异均有统计学意义(均P<0.05)。试验组和对照组的总药物不良反应发生率分别为6.45%(4例/62例)和3.23%(2例/62例),差异无统计学意义(P>0.05)。结论依折麦布联合瑞舒伐他汀治疗2型糖尿病合并高脂血症可改善患者血脂指标、减轻炎症反应,平稳血糖。

Objective To observe the clinical efficacy and safety of ezetimibe combined with rosuvastatin in the treatment of patients with type 2 diabetes mellitus and hyperlipidemia.Methods A total of 124 patients with type 2 diabetes mellitus and hyperlipidemia were randomly divided into control group and treatment group,62 cases in each group.Control group was treated with rosuvastatin calcium tablets,the initial dose was 5 mg,once a day,and the dose was adjusted according to blood lipid control.Treatment group was given ezetimibe 10 mg,oral,once a day on the basis of control group.Both groups were treated continuously for 3 months.The levels of blood glucose and adipocytokines in two groups were compared,and the total effective rate of clinical treatment and adverse drug reactions in two groups were counted.Results After treatment,the total effective rates of treatment group and control group were 91.94%(57 cases/62 cases)and 79.03%(49 cases/62 cases),with significant difference(P<0.05).The fasting blood glucose(FBG)in treatment group and control group were(6.21±0.34)and(6.42±0.37)mmol·L^(-1),and the glycosylated hemoglobin(HbA1c)were(6.37±0.52)%and(7.14±0.57)%,the adiponectin(ADPN)were(19.85±2.34)and(14.98±1.62)μg·mL^(-1),the endothelin(Visfatin)were(48.98±5.07)and(42.66±4.69)μg·mL^(-1),the serine protease inhibitors(Vaspin)were(3.36±0.89)and(4.52±1.21)μg·mL^(-1),the Chemerin were(82.11±15.98)and(98.66±21.71)ng·mL^(-1),the difference were all statistically significant(all P<0.05).The incidence of total adverse drug reactions in treatment group and control group were 6.45%(4 cases/62 cases)and 3.23%(2 cases/62 cases),respectively,the difference was not significant(P>0.05).Conclusion Ezetimibe combined with rosuvastatin in the treatment of type 2 diabetes mellitus with hyperlipidemia can improve blood lipid indexes,reduce inflammatory response and stabilize blood glucose.