利拉鲁肽、双歧杆菌三联活菌胶囊用于胰岛素+口服药疗效不佳的肥胖2型糖尿病患者的疗效观察  

Efficacy of Liraglutide and Bifidobacterium Triple Viable Capsules in the Treatment of Obese Type 2 Diabetes Mellitus with Poor Efficacy of Insulin+Oral Drugs

作　　者：刘玉斌[1] 王晓蕴[1] 马凌云[1] LIU Yubin;WANG Xiaoyun;MA Lingyun(Dept.of Endocrinology and Diabetes,Cangzhou Hospital of Integrated Traditional and Western Medicine,Hebei Cangzhou 062650,China)

机构地区：[1]河北省沧州中西医结合医院内分泌糖尿病科,河北沧州062650

出　　处：《中国医院用药评价与分析》2024年第7期818-822,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：2021年度中医药类科研计划课题(No.2021351)。

摘　　要：目的:基于血糖漂移、脂肪细胞炎症反应、磷脂酰肌醇3激酶(PI3K)/蛋白激酶B(Akt)通路,探讨利拉鲁肽+双歧杆菌三联活菌胶囊用于胰岛素+口服药疗效不佳的肥胖2型糖尿病(T2DM)患者的效果与机制。方法:前瞻性选取2022年6月至2023年6月该院收治的胰岛素+口服药疗效不佳的肥胖T2DM患者980例,采用单盲法,以随机数字表法分为利拉鲁肽组、联合组,各490例。两组患者均给予胰岛素+口服药;在此基础上,利拉鲁肽组患者给予利拉鲁肽,联合组患者给予利拉鲁肽+双歧杆菌三联活菌胶囊。比较两组患者的空腹血糖、餐后2 h血糖(2 hBG)、糖化血红蛋白(HbA1c)、体重指数(BMI)、胰岛素抵抗指数(HOMA-IR)、C肽、血糖漂移、平均血糖波动幅度(MAGE)、血糖曲线下面积(AUCPG)、脂肪细胞炎症反应指标[分泌型卷曲相关蛋白5(sfrp5)、内脂素(Visfatin)、趋化素(Chemerin)、肿瘤坏死因子α(TNF-α)和白细胞介素6(IL-6)]、PI3K/Akt通路[磷酸化PI3K(P-PI3K)、磷酸化Akt(P-Akt)和核因子κB(NF-κB)]及安全性。结果:治疗4、12周后,联合组患者空腹血糖、2 hBG和HbA1c水平低于利拉鲁肽组,BMI、HOMA-IR低于利拉鲁肽组,C肽水平高于利拉鲁肽组,血糖漂移系数、血糖漂移最大幅度、MAGE和AUCPG>7.8 mmol/L低于利拉鲁肽组,sfrp5水平高于利拉鲁肽组,Visfatin、Chemerin、TNF-α和IL-6水平低于利拉鲁肽组,P-PI3K、P-Akt水平高于利拉鲁肽组,NF-κB水平低于利拉鲁肽组,上述差异均有统计学意义(P<0.05)。利拉鲁肽组患者的不良反应发生率为1.22%(6/490),与联合组的0.61%(3/490)相比,差异无统计学意义(P>0.05)。结论:利拉鲁肽+双歧杆菌三联活菌胶囊用于胰岛素+口服药疗效不佳的肥胖T2DM患者,能发挥降糖和减重双重作用,改善患者血糖漂移、胰岛素抵抗和胰岛β细胞功能,抑制脂肪细胞炎症反应,调控PI3K/Akt通路,安全可靠,或可作为胰岛素+口服药疗效不佳的肥胖T2DM患OBJECTIVE:To probe into the efficacy and mechanism of liraglutide+Bifidobacterium triple viable capsules in the treatment of obese type 2 diabetes mellitus(T2DM)with poor efficacy of insulin+oral drugs based on blood glucose excursion,adipocyte inflammatory reaction and phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt)pathway.METHODS:A total of 980 patients with obese T2DM with poor efficacy of insulin+oral medication admitted to our hospital from Jun.2022 to Jun.2023 were prospectively selected,which were divided into liraglutide group and combination group via single-blind method and random number table method,with 490 cases in each group.Both groups were given insulin+oral medication;on that basis,the liraglutide group received liraglutide,and combination group was given liraglutide+Bifidobacterium triple viable capsule.The fasting blood glucose,2 h postprandial blood glucose(2 hBG),glycated hemoglobin(HbA 1c),body mass index(BMI),Insulin resistance index(HOMA-IR),C-peptide,glucose excursion,mean amplitude of glucose excursion(MAGE),area under the curve for blood glucose(AUC PG),adipocyte inflammatory response[secreted frizzled-related protein 5(sfrp5),Visfatin,Chemerin,tumor necrosis factorα(TNF-α),interleukin6(IL-6)],PI3K/Akt pathway[phosphorylated PI3K(P-PI3K),phosphorylated Akt(P-Akt)and nuclear factor-κB(NF-κB)]and safety were compared between two groups.RESULTS:After 4 and 12 weeks of treatment,the fasting blood glucose,2 hBG and HbA 1c levels of the combination group were lower than those of the liraglutide group,the BMI and HOMA-IR of the combination group were lower than those of the liraglutide group,the C-peptide of the combination group was higher than that of the liraglutide group,the glucose excursion coefficient,amplitude peak of glucose excursion,MAGE and AUC PG>7.8 mmol/L of the combination group were lower than those of the liraglutide group,the sfrp5 of the combination group was higher than that of the liraglutide group,the Visfatin,Chemerin,TNF-αand IL-6 levels of the combinati

关 键 词：血糖漂移 脂肪细胞 PI3K/AKT通路 利拉鲁肽 双歧杆菌三联活菌胶囊 肥胖 2型糖尿病 

分 类 号：R977.15[医药卫生—药品] R975[医药卫生—药学]