利格列汀对新诊断的2型糖尿病患者糖代谢及胰岛功能的影响  

Effects of linagliptin treatment on hyperglycemia and islet function in newly-diagnosed type 2 diabetic patients

作　　者：吴文俊[1] 陈雄[1] 沈飞霞[1] 项松英[2] 林迪妮[1] 谷雪梅[1] 

机构地区：[1]温州医科大学附属第一医院内分泌科,浙江温州325000 [2]温州医科大学附属第一医院妇科,浙江温州325000

出　　处：《中国新药与临床杂志》2014年第4期263-266,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家自然科学基金青年项目(81000356);温州市科技计划项目(Y20110186)

摘　　要：目的观察利格列汀对新诊断的2型糖尿病患者糖代谢和胰岛功能的影响。方法采用随机、双盲、安慰剂对照研究,新诊断2型糖尿病患者50例,随机分为两组,治疗组27例,安慰剂组23例。在饮食控制、运动治疗基础上,治疗组和安慰剂组分别给予利格列汀5 mg和安慰剂,口服,每日1次,疗程24周。检测治疗前后两组糖化血红蛋白(HbA1c)、空腹血糖(FBG)、餐后2 h血糖(2hPBG)、空腹胰岛素、体重、血脂、肝功能和血淀粉酶等指标,并计算稳态模型胰岛素抵抗指数(HOMA-IR)和β细胞功能指数(HOMA-β)。结果治疗后,两组HbA1c和2hPBG均有所下降,治疗组下降幅度大于安慰剂组(P<0.05)。治疗组FBG下降(1.25±1.50)mmol·L-1,HOMA-β上升12.73±19.76,安慰剂组FBG和HOMA-β无显著变化,两组差异显著(P<0.05)。两组血脂、肝功能、肾功能、血淀粉酶等均无明显变化,组间亦无显著差异(P>0.05)。治疗组发生低血糖1例,两组均无严重不良事件发生。结论利格列汀能有效降低新诊断2型糖尿病患者的血糖水平,并改善胰岛β细胞分泌功能。AIM To evaluate the effects of linagliptin on glucose metabolism and islet function for newly- diagnosed type 2 diabetes mellitus （T2DM） patients. METHODS A double- blind, randomized, placebo- controlled clinical trial was conducted. Fifty newly-diagnosed T2DM patients were enrolled in this study, and twenty-seven were randomized to therapy group and twenty-three to placebo group. Besides the base treatment of diet and exercise, the patients in the therapy or placebo group received linagliptin 5 mg daily orally or placebo, respectively. The levels of glycosylated hemoglobin Ale （HbAlc）, fasting blood glucose （FBG）, 2h postprandial blood glucose （2hPBG） , fasting serum insulin, weight, lipid profiles, liver function and amylase were observed before and after 24-week treatment. Homeostasis model assessment insulin resisitance index （HOMA-IR） and homeostasis model assessment beta-cell function index （HOMA-[5） were calculated. RESULTS After 24 weeks of follow-up, HbA1c and 2hPBG decreased in both groups, but a greater reduction in linagliptin group compared with placebo group （P 〈 0.05）. FBG and HOMA-β achieved no statistically difference with placebo.Linagliptin decreased FBG by （1.25 ± 1.50） mmol·^L-1, and increased HOMA-β by 12.73 ±19.76 （P 〈 0.05）. No significant difference on lipid profiles, liver and renal function, amylase after 24-week treatment in each group compared with baseline, there was no differerce between the two groups either （P 〉 0.05）. One hypoglycemic event occurred in the therapy group and no serious adverse event occurred in both groups.CONCLUSION To newly- diagnosed T2DM patients, monotherapy with linagliptin produced a significant clinical meaningful improvement in glycemic control, accompanied by enhanced parameters of beta- cell function.

关 键 词：利格列汀 糖尿病 2型 血糖 胰岛功能 

分 类 号：R977[医药卫生—药品]