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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。
Objective To investigate the effects of linagliptin on glucose metabolism and islet function in newly diagnosed type 2 diabetic patients. Methods A randomized, double-blind, placebo-controlled study of 50 newly diagnosed type 2 diabetic patients was randomly divided into two groups: treatment group (27 cases) and placebo group (23 cases). On the basis of diet control and exercise therapy, the treatment group and the placebo group were given linagliptin 5 mg and placebo orally, once daily for 24 weeks. HbA1c, FBG, 2hPBG, fasting insulin, body weight, blood lipid, liver function and serum amylase were detected before and after treatment. The insulin resistance index (HOMA-IR) and beta cell function index (HOMA-beta). Results After treatment, the levels of HbA1c and 2hPBG decreased in both groups, with the treatment group decreasing more than the placebo group (P <0.05). FBG in treatment group decreased (1.25 ± 1.50) mmol·L-1, HOMA-β increased by 12.73 ± 19.76, FBG and HOMA-β in placebo group showed no significant difference (P <0.05). No significant changes were found in blood lipids, liver function, renal function, blood amylase, etc. There was no significant difference between the two groups (P> 0.05). One case of hypoglycemia occurred in the treatment group, and no serious adverse events occurred in both groups. Conclusions Linagliptin can effectively reduce the blood glucose level in newly diagnosed type 2 diabetic patients and improve the pancreatic β-cell secretory function.