摘要
目的观察胰岛素替代治疗6 mo以上、血糖未达标的2型糖尿病患者联合西格列汀治疗的疗效。方法采用随机、单盲、安慰剂对照研究。98例胰岛素治疗未达标的2型糖尿病患者随机分为西格列汀组50例和安慰剂组48例,西格列汀组加用西格列汀100 mg·d^(-1),疗程为24 wk。检测2组用药前后的空腹血糖(FBG)、餐后2 h血糖(2 h PBG)、糖化血红蛋白(HbA_(1c))、24 h葡萄糖曲线下面积(AUC)、血糖变异系数(CV)、血清C肽、血清胰高血糖素、血脂、体重等指标,并观察不良事件。结果治疗前2组各项指标均无显著差异(P>0.05)。西格列汀组完成46例,安慰剂组完成45例。治疗后安慰剂组24 h葡萄糖AUC升高(P<0.05),其他指标均无明显变化(P>0.05)。西格列汀组治疗后FBG、2 h PBG、HbA_(1c)、24 h葡萄糖AUC、血糖CV、空腹和餐后2 h胰高血糖素分别下降(1.5±0.9)mmol·L^(-1)、(2.9±3.3)mmol·L-1、(0.8±1.6)%、(2 782±901)mmol·L^(-1)·min、2.1±1.2、(29.1±19.2)ng·L^(-1)和(42.4±25.4)ng·L^(-1),且低于安慰剂组(P<0.05);空腹和餐后2 h C肽上升(0.15±0.21)μg·L^(-1)和(0.79±0.68)μg·L^(-1),且高于安慰剂组(P<0.05);每月低血糖总发生例次降低,且低于安慰剂组。2组均未发生严重不良反应。结论西格列汀可以协助降低后期2型糖尿病患者血糖,减少血糖波动。
AIM To investigate the efficacy of sitagliptin on type 2 diabetes mellitus with unsatxstlecl blood glucose level after insulin treatment. METHODS In this randomized, single-blind, placebo controlled study, 98 patients with type 2 diabetes without reaching glycemic targets were randomized into two groups. Fifty patients in the sitagliptin group received sitagliptin 100 mg·d-1, while the other 48 patients in the placebo group received placebo individually, with a course of 24 wk for each. The levels of fasting blood glucose （FBG）, 2 h postprandial blood glucose （2 h PBG） , glycosylated hemoglobin A1c （HbA1c） , 24 h area under the curve （AUC） of glucose, the blood glucose coefficient of variation （CV）, fasting and 2 h postprandial serum C- peptide （CP） and glucagon, body weight and the times of hypoglycemia were observed before and after the treatments. RESULTS There were no significantly difference in baseline characteristics between two groups （P 〉 0.05）, while 46 and 45 patients finished study in the sitagliptin and placebo group respectively. After 24 wk treatment, no obvious changes occurred but 24 h AUC of glucose increased （P 〈 0.05） in the placebo group. The levels of FBG, 2 h PBG, HbA1c, AUC of glucose, CV of glucose, fasting and 2 h postprandial serum glucagon decreased （1.5 ± 0.9） mmol·L-1, （2.9 ± 3.3） mmol·L-1, （0.8 ± 1.6） %, （2 782 ± 901） mmol·L-1·min, 2.1 ± 1.2, （29.1 ± 19.2） ng·L-1 and （42.4 ± 25.4） ng·L-1 in the sitaglipin group （P 〈 0.05） and were lower than those in the placebo group （P 〈 0.05）. The fasting and 2 h postprandial serum CP increased （0.15 ± 0.21） μg·L-1 and （0.79 ± 0.68） μg·L-1, and were higher than those in the placebo group （P 〈 0.05）. The total times of hypoglycaemia per month decreased in the sitagliptin group and was lower than that in the placebo group. No serious adverse reaction occurred in both groups. CONCLUSION Sitagliptin may improve the level and fluctuation of blood
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2012年第9期557-560,共4页
Chinese Journal of New Drugs and Clinical Remedies
