德谷门冬双胰岛素联合二甲双胍治疗T2DM患者胰岛素抵抗的临床研究  

Clinical trial of insulin degludec/insulin aspart combined with metformin in the treatment of insulin resistance in T2DM patients

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作  者:郑振 杨宁宁 范学明 ZHENG Zhen;YANG Ning-ning;FAN Xue-ming(Department of Endocrinology,Lu'an Hospital Affiliated to Anhui Medical University,Lu'an 237000,Anhui Province,China)

机构地区:[1]安徽医科大学附属六安医院内分泌科,安徽六安237000

出  处:《中国临床药理学杂志》2025年第3期311-315,共5页The Chinese Journal of Clinical Pharmacology

摘  要:目的分析德谷门冬双胰岛素注射液联合二甲双胍缓释片对2型糖尿病(T2DM)患者胰岛素抵抗的影响。方法将T2DM患者按照队列法分为对照组和试验组。对照组患者口服二甲双胍缓释片(每次0.5 g,tid)及皮下注射甘精胰岛素注射液(10 U,qd)治疗,试验组口服二甲双胍缓释片(每次0.5 g,tid)及皮下注射德谷门冬双胰岛素注射液(0.1~0.2 U·kg^(-1)·d^(-1),早晚餐前平均分配)治疗,2组均治疗12周。比较2组患者疗效,比较血糖控制情况[空腹血糖、餐后2 h血糖、糖化血红蛋白(HbA1c)]、胰岛素功能情况[空腹胰岛素(FINS)、胰岛素抵抗指数(HOMA-IR)、胰岛β细胞功能(HOMA-β)]及进行安全性评价。结果试验组和对照组分别入组49和51例。试验组和对照组总有效率分别为93.88%(46例/49例)和80.39%(41例/51例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的空腹血糖分别为(5.83±0.79)和(6.53±0.81)mmol·L^(-1),餐后2 h血糖分别为(7.73±0.86)和(8.41±0.97)mmol·L^(-1),HbA1c分别为(6.34±0.88)%和(6.80±0.92)%,FINS分别为(6.02±1.13)和(7.13±1.04)mU·L^(-1),HOMA-IR分别为1.56±0.20和2.07±0.23,HOMA-β分别为51.67±3.18和47.06±3.31,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为低血糖、恶心、头晕、腹泻;对照组的药物不良反应主要为低血糖、恶心。试验组和对照组的药物不良反应总发生率分别为10.20%(5例/49例)和11.76%(6例/51例),在统计学上差异无统计学意义(P>0.05)。结论德谷门冬双胰岛素注射液联合二甲双胍缓释片治疗能改善T2DM患者胰岛素抵抗和调节血糖水平,安全性较好。Medical University;Objective To analyze the effect of insulin degludec/insulin aspart injection combined with metformin extended-release tablets on insulin resistance in patients with type 2 diabetes mellitus(T2DM).Methods T2DM patients were divided into control group and treatment group using a cohort method.The control group received oral metformin extended-release tablets(0.5 g,tid)and subcutaneous injections of insulin glargine injection(10 U,qd),while the treatment group received oral metformin extended-release tablets(0.5 g,tid)and subcutaneous injections of insulin degludec/insulin aspart injection(0.1-0.2 U·kg^(-1)·d^(-1),evenly divided before breakfast and dinner).Both groups were treated for 12 weeks.The efficacy,blood glucose control[fasting blood glucose,2-hour postprandial blood glucose,glycated hemoglobin A1c(HbA1c)],insulin function[fasting insulin(FINS),homeostasis model assessment of insulin resistance(HOMA-IR)and homeostasis model assessment-β(HOMA-β)]were compared,and safety was evaluated.Results A total of 49 cases were enrolled in the treatment group and 51 cases in the control group.The overall effective rates in the treatment and control groups were 93.88%(46 cases/49 cases)and 80.39%(41 cases/51 cases),respectively,showing a statistically significant difference(P<0.05).After treatment,the fasting blood glucose levels in the treatment and control groups were(5.83±0.79)and(6.53±0.81)mmol·L^(-1);the 2-hour postprandial blood glucose levels were(7.73±0.86)and(8.41±0.97)mmol·L~(-1);HbA1c levels were(6.34±0.88)%and(6.80±0.92)%;FINS levels were(6.02±1.13)and(7.13±1.04)mU·L~(-1);HOMA-IR values were 1.56±0.20 and 2.07±0.23;HOMA-βvalues were 51.67±3.18 and 47.06±3.31,respectively,with all differences being statistically significant(all P<0.05).The adverse drug reactions in the treatment group mainly included hypoglycemia,nausea,dizziness,and diarrhea,while the adverse drug reactions in the control group mainly included hypoglycemia and nausea.The incidence of adverse drug reactio

关 键 词:德谷门冬双胰岛素注射液 二甲双胍缓释片 2型糖尿病 血糖 胰岛素抵抗 

分 类 号:R977.15[医药卫生—药品]

 

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