西格列汀联合格列美脲治疗2型糖尿病伴轻度肥胖患者的临床研究  

Clinical trial of sitagliptin combined with glimepiride in the treatment of patients with type 2 diabetes mellitus complicated with mild obesity

作　　者：吕文艳[1] 郭威[2] 刘丹 王崇欣 张云涵[1] 朱冉[1] 杨越峰 LÜWen-yan;GUO Wei;LIU Dan;WANG Chong-xin;ZHANG Yun-han;ZHU Ran;YANG Yue-feng(School of Nursing,Nanyang Medical College,Nanyang 473000,Henan Province,China;Departmenot of Endocrinology,The First Affiliated Hospital of Nanyang Medical College,Nanyang 473000,Henan Province,China;Department of Neurology,Nanshi Hospital of Nanyang,Nanyang 473000,Henan Province,China)

机构地区：[1]南阳医学高等专科学校护理系,河南南阳473000 [2]南阳医学高等专科学校第一附属医院内分泌科,河南南阳473000 [3]南阳南石医院神经内科,河南南阳473000

出　　处：《中国临床药理学杂志》2023年第20期2910-2914,共5页The Chinese Journal of Clinical Pharmacology

基　　金：河南省教育科学“十三五”规划一般课题资助项目(【2018】JKGHYB-0498)。

摘　　要：目的 观察磷酸西格列汀片联合格列美脲片治疗2型糖尿病伴轻度肥胖患者的临床疗效及安全性。方法 将2型糖尿病伴轻度肥胖患者随机分为对照组和试验组。对照组给予磷酸西格列汀每次100 mg,qd,口服;试验组在对照组治疗的基础上,给予格列美脲每次2 mg,qd,口服。2组患者均治疗6个月。比较2组患者的临床疗效、血糖、胰岛素功能和血脂水平,以及药物不良反应的发生情况。结果 试验组入组155例,脱落1例,最终154例纳入分析;对照组入组155例,脱落1例,最终154例纳入分析。治疗后,试验组和对照组的总有效率分别为97.40%(150例/154例)和92.21%(142例/154例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的空腹血糖分别为(5.54±1.24)和(6.98±1.30)mmol·L^(-1),餐后2 h血糖分别为(8.62±1.49)和(10.58±1.34)mmol·L^(-1),糖化血红蛋白分别为(6.04±0.58)%和(6.58±0.46)%,空腹胰岛素分别为(4.97±0.58)和(5.12±0.67)μU·mL^(-1),胰岛β细胞功能指数分别为48.73±1.24和39.43±1.57,胰岛素抵抗指数分别为1.22±0.84和1.59±0.78,总胆固醇分别为(4.65±1.04)和(4.89±1.02)mmol·L^(-1),三酰甘油分别为(2.08±0.35)和(2.19±0.37)mmol·L^(-1),低密度脂蛋白分别为(2.69±1.08)和(2.94±1.06)mmol·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有低血糖、腹泻和恶心,对照组的药物不良反应主要有头痛和恶心。试验组和对照组的总药物不良反应发生率分别为1.95%和1.30%,差异无统计学意义(P>0.05)。结论 磷酸西格列汀片联合格列美脲片治疗2型糖尿病伴轻度肥胖患者的临床疗效确切,其能有效地改善患者的血糖、血脂和胰岛素功能,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of sitagliptin phosphate tablets combined with glimepiride tablets in the treatment of patients with type 2 diabetes mellitus complicated with mild obesity.Methods The patients with type 2 diabetes mellitus and mild obesity were randomly divided into control and treatment groups.The control group was given sitagliptin phosphate 100 mg per time,qd,orally.On the basis of control group,the treatment group received glimepiride 2 mg per time,qd,orally.Two groups were treated for 6months.The clinical efficacy,blood glucose,insulin function,levels of blood lipids and adverse drug reactions were compared between the two groups of patients.Results In treatment group,155 cases were enrolled but 1 case was drop out,thus 154 cases were finally included in the analysis.In control group,155 cases were enrolled but 1 case was drop out,thus finally 154cases were included in the analysis.After treatment,the total effective rates of treatment group and control group were97.40%(150 cases/154 cases) and 92.21%(142 cases/154 cases) with significant difference (P0.05).After treatment,the fasting plasma glucose levels of treatment and control groups were (5.54±1.24) and (6.98±1.30)mmol·L^(-1),the 2 hours plasma glucose levels were (8.62±1.49) and (10.58±1.34) mmol·L^(-1),the glycated hemoglobin A1c levels were (6.04±0.58)%and (6.58±0.46)%,the fasting insulin levels were (4.97±0.58)and (5.12±0.67)μU·m L^(-1),the homa beta cell function index values were 48.73±1.24 and 39.43±1.57,the homeostasis model of assessment for insulin resistence index values were 1.22±0.84 and 1.59±0.78,the total cholesterol levels were (4.65±1.04) and (4.89±1.02) mmol·L^(-1),the triacylglycerol levels were (2.08±0.35)and (2.19±0.37) mmol·L^(-1),the low density lipoprotein levels were (2.69±1.08) and (2.94±1.06)mmol·L^(-1),the differences were statistically significant (all P0.05).The adverse drug reactions in treatment group were hypoglycemia,diarrhea and nausea,while the adverse dru

关 键 词：磷酸西格列汀片 格列美脲片 2型糖尿病伴轻度肥胖 临床疗效 安全性评价 

分 类 号：R977.15[医药卫生—药品]