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目的探讨利格列汀在单用二甲双胍效果不佳的2型糖尿病(T2DM)患者中的治疗效果,为利格列汀在糖尿病治疗方面的应用提供依据。方法选取2013年8月至2014年5月在第四军医大学西京医院内分泌代谢科门诊就诊的60例T2DM患者作为研究对象,将患者随机分为利格列汀组(30例)和对照组(30例),利格列汀组在二甲双胍的基础上加用利格列汀进行治疗,对照组在二甲双胍的基础上使用安慰剂进行治疗。分别于基线和治疗24周后,测量两组患者的体重、血压,测定糖化血红蛋白(HbA1C)、空腹血糖(FPG)、餐后2 h血糖(2 hPG)、空腹胰岛素(FINS)、肝功能、血脂和血淀粉酶的变化,并计算胰岛素抵抗指数(HOMA-IR)和β细胞功能指数(HOMA-β),用SPSS 18.0软件进行t检验和χ~2检验。结果治疗24周后,利格列汀组患者HbA1C水平由治疗前的8.5%±1.7%降至6.8%±2.1%,FPG由治疗前的(8.9±2.4)mmol/L降至(6.6±2.2)mmol/L,2 hPG由治疗前的(13.8±3.4)mmol/L降至(8.8±3.9)mmol/L;对照组患者HbA1C水平由治疗前的8.5%±2.0%降至7.8%±1.3%,FPG由治疗前的(8.9±3.5)mmol/L降至(8.1±2.9)mmol/L,2 hPG由治疗前的(13.9±3.8)mmol/L降至(10.7±4.1)mmol/L。两组上述指标比较,差异均有统计学意义(P<0.01,P<0.05)。治疗24周后,利格列汀组的HOMA-β为(53.6±16.2),较治疗前(46.3±13.4)明显升高,HOMA-IR为(2.2±0.4),较治疗前(3.6±0.7)明显下降;对照组的HOMA-β干预后为(48.3±18.6),较治疗前(45.9±13.9)明显升高,HOMA-IR(2.4±0.6)较治疗前(3.6±0.2)有所下降。两组治疗前后HOMA-β、HOMA-IR比较,差异均有统计学意义(P<0.05)。两组患者在治疗后,体重及血压均有所下降,但两组间差异无统计学意义(P>0.05)。结论对于单用二甲双胍治疗效果不佳的T2DM患者,加用利格列汀能够有效地控制血糖,改善胰岛β细胞的分泌功能,并且不增加低血糖及体重增加的风险。
Objective To investigate the therapeutic effect of linagliptin in patients with type 2 diabetes mellitus (T2DM) who are refractory to metformin alone and provide the basis for the application of linagliptin in the treatment of diabetes mellitus. Methods Sixty T2DM patients treated in endocrinology and outpatient department of Xijing Hospital of the Fourth Military Medical University from August 2013 to May 2014 were selected as the research object. The patients were randomly divided into two groups: the litanlitazing group (n = 30) and the control group 30 cases). The linagliptin group was treated with linagliptin on the basis of metformin, while the control group was treated with placebo on the basis of metformin. Body weight and blood pressure were measured at baseline and 24 weeks after treatment. The levels of HbA1C, FPG, 2 hPG, FINS, liver function, Blood lipid and amylase were measured. HOMA-β and HOMA-β were calculated. Student’s t-test and χ ~ 2 test were performed with SPSS 18.0 software. Results After 24 weeks of treatment, the HbA1C level in the linagliptin group decreased from 8.5% ± 1.7% before treatment to 6.8% ± 2.1%, and FPG decreased from (8.9 ± 2.4) mmol / L before treatment to (6.6 ± 2.2) ) mmol / L and 2 hPG decreased from (13.8 ± 3.4) mmol / L to (8.8 ± 3.9) mmol / L before treatment, while the control group decreased HbA1C level from 8.5% ± 2.0% to 7.8% ± 1.3 %, FPG decreased from (8.9 ± 3.5) mmol / L to (8.1 ± 2.9) mmol / L before treatment and from (13.9 ± 3.8) mmol / L before treatment to (10.7 ± 4.1) mmol / L . There was significant difference between the above two indexes (P <0.01, P <0.05). After 24 weeks of treatment, the HOMA-β in linagliptin group was significantly higher than that in pretreatment group (53.6 ± 16.2 vs 46.3 ± 13.4, HOMA-IR was (2.2 ± 0.4) vs (48.3 ± 18.6) in HOMA-β group, which was significantly higher than that before treatment (45.9 ± 13.9), HOMA-IR (2.4 ± 0.6) was lower than that before treatment . The difference of HOMA-βand HOMA-IR between the two groups before and after treatment were statistically significant (P <0.05). The weight and blood pressure of both groups decreased after treatment, but there was no significant difference between the two groups (P> 0.05). Conclusion For patients with T2DM who are refractory to metformin only, the addition of linagliptin can effectively control blood glucose and improve the secretion of pancreatic β cells without increasing the risk of hypoglycemia and weight gain.