度拉糖肽联合门冬胰岛素和二甲双胍治疗老年T2DM伴肥胖患者的临床研究  

Clinical trial of dulaglutide combined with insulin aspart and metformin in the treatment of elderly patients with T2DM and obesity

作　　者：谢青青 王明太[2] 张东铭[3] 李翠凡 崔璨璨 XIE Qing-qing;WANG Ming-tai;ZHANG Dong-ming;LI Cui-fan;CUI Can-can(School of Medicine,Sias University,Zhengzhou 451150,Henan Province,China;Emergency Department,The Second Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,Henan Province,China;Endocrinology Department,The Second Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,Henan Province,China)

机构地区：[1]郑州西亚斯学院医学院,河南郑州451150 [2]郑州大学第二附属医院.急诊科,河南郑州450000 [3]郑州大学第二附属医院内分泌科,河南郑州450000

出　　处：《中国临床药理学杂志》2024年第20期2934-2938,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察度拉糖肽注射液联合门冬胰岛素注射液和二甲双胍片对老年2型糖尿病(T2DM)伴肥胖患者血糖、胰岛β细胞状态、体格的影响。方法将老年T2DM伴肥胖患者按队列法分为对照组和试验组。2组患者均给予0.4~0.6 U·kg^(-1)·d^(-1)门冬胰岛素注射液进行胰岛素强化治疗,服用二甲双胍片0.5 g,tid。对照组1周后更换成序贯治疗予以甘精胰岛素注射液,起始剂量0.4~0.6 U·kg^(-1)·d^(-1),qn,同时结合血糖浓度调整剂量,期间继续予以二甲双胍片0.5 g,tid,连续12周;试验组1周后更换成序贯治疗予以度拉糖肽注射液1.5 mg,每周1次,期间继续予以二甲双胍片0.5 g,tid,连续12周。比较2组患者的临床疗效、血糖水平[糖化血红蛋白(HbAlc)、空腹血糖(FPG)]、胰岛β细胞状态[空腹胰岛素(FINS)、胰岛β细胞功能指数(HOMA-β)以及胰岛素抵抗指数(HOMA-IR)]、体格参数[腰围、体质量指数(BMI)],并进行安全性评价。结果试验组和对照组分别入组53例和51例。治疗后,试验组和对照组的总有效率分别为98.11%(52例/53例)和84.31%(43例/51例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的HbAlc分别为(7.01±0.75)%和(7.63±0.82)%,FPG分别为(6.23±0.70)和(6.62±0.74)mmol·L^(-1),FINS分别为(5.25±1.06)和(6.48±1.12)mU·L^(-1),HOMA-β分别为32.62±6.53和27.19±5.18,HOMA-IR分别为1.31±0.25和1.65±0.28,腰围分别为(82.31±6.04)和(85.79±6.82)cm,BMI分别为(27.14±1.23)和(27.91±1.15)kg·m^(-2)。试验组的上述指标与对照组比较,在统计学上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恶心、呕吐、皮疹;对照组的药物不良反应主要有恶心、呕吐。试验组和对照组的总药物不良反应发生率分别为11.32%和9.80%,在统计学上差异无统计学意义(P>0.05)。结论度拉糖肽注射液联合门冬胰岛素注射液和二甲双胍片能有效改善老年T2DM伴肥胖患者血糖、�Objective To observe the effect of dulaglutide combined with insulin aspart and metformin on blood glucose,pancreatic beta-cell status and physique in elderly patients with type 2 diabetes mellitus(T2DM)and obesity.Methods Elderly patients with T2DM and obesity were divided into the control group and the treatment group according to the queue method.Both groups were given intensive insulin therapy with insulin aspart injection at 0.4-0.6 U·kg^(-1)·d^(-1)and oral administration of 0.5 g of metformin tablets,tid.A week later,the treatment of control group was switched to sequential therapy with insulin glargine injection at an initial dose of 0.4-0.6 U·kg^(-1)·d^(-1),qn.The dose was adjusted according to blood glucose concentration.During this period,0.5 g of metformin tablets was administrated,tid,for 12 consecutive weeks.Meanwhile,treatment of the treatment group was switched to sequential therapy with 1.5 mg of dulaglutide injection,once a week.During this period,0.5 g of metformin tablets was administrated,tid,for 12 consecutive weeks.The two groups were compared in terms of clinical efficacy,blood glucose level[glycosylated hemoglobin(HbAlc),fasting plasma glucose(FPG)],pancreatic beta-cell status[fasting insulin(FINS),homeostasis model assessment-β(HOMA-β)and homeostasis model assessment-insulin resistance index(HOMA-IR)],and physical parameters[waist circumference and body mass index(BMI)].Safety was evaluated.Results Fifty-three cases and fifty-one cases were included in the treatment group and the control group,respectively.After treatment,the total effective rates of the treatment group and the control group were 98.11%(52 cases/53 cases)and 84.31%(43 cases/51 cases),and the difference was statistically significant(P<0.05).After treatment,HbAlc in the treatment and the control group were(7.01±0.75)%and(7.63±0.82)%;FPG levels were(6.23±0.70)and(6.62±0.74)mmol·L^(-1);FINS levels were(5.25±1.06)and(6.48±1.12)mU·L^(-1);HOMA-βwere 32.62±6.53 and 27.19±5.18;HOMA-IR were 1.31±0.25 and1.65±0.28

关 键 词：门冬胰岛素注射液 度拉糖肽注射液 二甲双胍片肥胖 2型糖尿病 老年患者 

分 类 号：R977.15[医药卫生—药品]