| Objective: In this study, through the observation of the clinical effect of sitagliptin based on metformin combined in the treatment of type 2 diabetes mellitus(T2DM) in Yan’an to investigate effectiveness and safety of sitagliptin as second line drugs for the treatment of T2 DM in the prevention and treatment of type 2 diabetes guildline.Methods: 85 cases of T2 DM patients with poor control of blood glucose from the Department of endocrinology of Affiliated Hospital of Yan’an University, including 45 cases of male patients, 40 female patients, the average age of 52.3 years, in the Sitagliptin Phosphate Tablets 100mg/d to application to add metformin(Glucophage) 1500mg/d based on for 20 weeks, measured before and after the treatment of glycosylated hemoglobin(Hb A1c), fasting blood glucose(FBG), body weight(Wt), heart rate(HR), blood pressure(BP), alanine aminotransferase(ALT) and aspartate aminotransferase(AST), total bilirubin(TBil), triglyceride(TC), cholesterol(TG), low density lipoprotein(LDL-C), high density lipoprotein(HDL-C),observing the glycosylated Hemoglobin change, fasting blood glucos compared to the baseline after treatment, to evaluate the hypoglycemic effect and changes in body weight, heart rate, blood pressure, liver function, blood lipid were observed after medication and adverse events in order to investigate the clinical hypoglycemic and the occurrence of effect and safety of sitagliptin phosphate.Results: 1. Before and after treatment, body weight of patients decreased slightly, but the difference was not statistically significant(70.84±10.40 vs.70.15±10.74 P=0.069>0.05), that after the treatment no change in body weight; after treatment the heart rate of patients was slightly higher than that of the treatment before, but the difference was not statistically significant(71.55±8.46 vs.73.22±6.17, P=0.108>0.05). 2. After the treatment,the patient medication glycated hemoglobin was significantly lower than before, and the difference was statistically significant(7.98±0.70 vs. 6.89 ±0.73, P < 0.001); fasting blood glucose was significantly decreased than before, and the difference is statistically significant(8.12±1.55 vs. 753 ±1.37, P < 0.001). 3. After the treatment, the patient medication triglyceride increased than before, but the difference was not statistically significant(1.41±1.00 vs.1.59±1.21, P=0.168>0.05); cholesterol slightly increased compared with before, and the differences have statistical significance(4.15±1.07 vs. 4.38±0.95, P = 0.026 < 0.05); After the treatment,low density lipoprotein increased slightly than before, but the difference was not statistically significant(1.03±0.29 vs. 1.04±0.28, P=0.747>0.05); high density lipoprotein(HDL) increased compared with those before treatment, and the difference has statistical significance(2.52 ±0.87 vs. 2.84±0.74, P = 0.001 < 0.05). 4. Before and after treatment, the patients’ alanine aminotransferase decreased, but the difference was not statistically significant(25.60±16.78 vs.22.69±14.24, P=0.112> 0.05); after treatment, glutamic oxalacetic transaminase lower than before, but the difference was not statistically significant(19.57±9.50 vs.17.90±15.47,P=0.391>0.05); after the treatment,the total bilirubin of patients is lower than before, and the difference was statistically significant(13.16±5.57 vs.10.63±4.72, P < 0.001). 5. After treatment, systolic blood pressure slightly increased than before, and the difference was statistically significant(120.17±15.76 vs. 124.04±14.36, P=0.027 < 0.05); After treatment,diastolic blood pressure taking a slightly increase than before, but the differences without statistical significance(76.10±8.61 vs.76.71±9.39, P = 0.607 > 0.05). 6. After treatment,the compliance of glycated hemoglobin(Hb A1c<7%) were 46 cases, compliance rate was 59.7%.for males were 29 cases, compliance rate was 64.4%, female were 17 cases, compliance rate was 53.1%.during the study,there is 1 patients that glycosylated hemoglobin increased significantly. 7. During the study,one patient felt unwell after take sitagliptin 9 days, the performance for bloating, back pain, and the symptoms relieved after stoping the drug for 3-4 days; 1 patient dropped out of the study because of elevated blood sugar; the AST of 1 patient increased significantly after taking this therapy for 16 weeks, greater than the upper limit of normal value more than 2 times; throughout the study did not appear hypoglycemiaConclusion: 1.Sitagliptin can effectively reduce the Hb Alc, FBG of T2 DM and are used in combination with metformin, the effect is more significant, can be widely used for the the patients with T2 DM whose clinical blood sugar are not controlled well 2.Metformin combined with sitagliptin can increase TC, LDL-C. 3. Metformin combined with sitagliptin is safe and reliable to cure the patients with T2 DM and low rate of clinical adverse events. |
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