达格列净联合二甲双胍在新诊断2型糖尿病合并内脏脂肪肥胖患者中的应用

Application of dapagliflozin combined with metformin in newly diagnosed type 2 diabetes patients with visceral fat obesity

目的观察达格列净在新诊断2型糖尿病(type 2 diabetes,T2DM)合并内脏脂肪肥胖患者中的应用,探讨T2DM合并内脏脂肪肥胖的治疗方案。方法本研究为前瞻性随机对照研究,以珠海市人民医院新诊断的90例T2DM合并内脏脂肪肥胖患者作为研究对象,采用随机数字表法分为A、B、C 3组,各30例。3组均给予一般治疗,在此基础上A组服用达格列净片,B组服用二甲双胍缓释片,C组服用达格列净片+二甲双胍缓释片,共干预12周。干预12周时,比较3组体重、体重指数(body mass index,BMI)、糖脂水平[空腹血糖(fasting blood-glucose,FBG)、餐后2 h血糖(postprandial 2 h blood glucose,2 hBG)、糖化血红蛋白(glycated hemoglobin glycosylated hemoglobin,HbA_(1c))、总胆固醇(total cholesterol,TC)、三酰甘油(triacylglycerol,TG)、高密度脂蛋白胆固醇(high density lipoprotein cholesterol,HDL-C)、低密度脂蛋白胆固醇(low density lipoprotein cholesterol,LDL-C)]、脂肪面积(内脏脂肪面积、皮下脂肪面积)、人体成分(身体总水分、细胞内水分、细胞外水分、脂肪占比)、肝肾功能[天冬氨酸转氨酶(aspartate transaminase,AST)、丙氨酸转氨酶(alanine transaminase,ALT)、血肌酐(serum creatinine,Scr)、尿素氮(usea nitrogen,BUN)]及干预期间不良反应发生率。结果干预12周,3组体重、BMI较干预前降低,且C组体重、BMI较A组、B组低,A组体重、BMI较B组低,差异有统计学意义(P<0.05)。干预12周,3组FBG、2 hBG、TC、TG、LDL-C、HbA_(1c)水平较干预前降低,HDL-C较干预前升高,且C组水平改善程度高于A组、B组,A组水平改善程度高于B组,差异有统计学意义(P<0.05)。干预12周,3组内脏脂肪面积、皮下脂肪面积较干预前缩小,脂肪百分比较干预前降低,身体总水分、细胞内水分、细胞外水分较干预前增多,且C组内脏脂肪面积、皮下脂肪面积较A组、B组小,脂肪百分比较A组、B组低,身体总水分、细胞内水分、细胞外水分较A组、B组多,A组内脏脂肪面积、皮下脂肪面积较B组小,脂肪百分比较B组低,身体总水分、细胞内水分、细胞外水分较B组多,差异有统计学意义(P<0.05)。干预12周,3组AST、ALT水平较干预前比较,差异无统计学意义(P>0.05);A组、C组Scr、BUN水平较治疗前降低且均低于B组,差异有统计学意义(P<0.05);B组Scr、BUN水平较治疗前比较,差异无统计学意义(P>0.05)。3组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论T2DM合并内脏脂肪肥胖患者接受达格列净联合二甲双胍治疗后能够通过增强降糖、降脂,改善人体成分含量的作用,达到减轻患者体重的效果,且达格列净能够发挥肾脏保护作用,联合用药对于肝肾功能并不明显影响,具有一定安全性。

Objective To observe the application of dapagliflozin in newly diagnosed type 2 diabetes mellitus(T2DM)patients with visceral fat obesity,and to explore the treatment scheme of T2DM patients with visceral fat obesity.Methods This study was a prospective randomized controlled study,with 90 newly diagnosed T2DM patients with visceral adiposity in Zhuhai People′s Hospital as the research subjects.A random number table method was used to divide them into groups A,B and C,with 30 cases in each group.The three groups were given general treatment,and on this basis,group A took Dagalijing Tablets,group B took Metformin Sustained-release Tablets,and group C took Dagalijing Tablets+Metformin Sustained-release Tablets;the intervention lasted for 12 weeks.At 12 weeks after intervention,the body weight,body mass index(BMI),glucose and lipid levels[fasting blood glucose(FBG),2 h postprandial blood glucose(2 hBG),glycosylated hemoglobin(HbA_(1c)),total cholesterol(TC),triglyceride(TG),high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C)],fat area(visceral fat area,subcutaneous fat area),human body composition(total body water,intracellular water,extracellular water and fat proportion),liver and kidney function[aspartate transaminase(AST),alanine transaminase(ALT),serum creatinine(Scr),and urea nitrogen(BUN)]and the incidence of adverse reactions during intervention were compared among three groups.Results At 12 weeks after intervention,the body weight and BMI of the three groups were lower than those before intervention,and the body weight and BMI of group C were lower than those of group A and group B,and lower in group A than in group B,suggesting significant differences(P<0.05).At 12 weeks after intervention,the levels of FBG,2 hBG,TC,TG,HbA_(1c),and LDL-C in the three groups were lower than those before the intervention,and the HDL-C levels were higher than those before the intervention;the improvement level was higher in group C than in group A and group B,and in group A than in group B,suggesting significant differences(P<0.05).At 12 weeks after intervention,the area of visceral fat and subcutaneous fat in the three groups were decreased,and the percentage of fat was decreased,while the total body water,intracellular water and extracellular water were increased.The visceral fat area and subcutaneous fat area in group C were smaller than those in group A and group B,the fat percentage was lower than those in group A and group B,and the total body water,intracellular water and extracellular water were more than those in group A and group B.The visceral fat area and subcutaneous fat area in group A were smaller than those in group B,the fat percentage was lower than that in group B,and the total body water,intracellular water and extracellular water were more than those in group B,suggesting significant differences(P<0.05).At 12 weeks after intervention,there was no statistical significant difference in AST and ALT levels among the three groups compared with those before intervention(P>0.05).The levels of Scr and BUN in group A and C were lower than those before treatment and those in group B,and the difference was statistically significant(P<0.05).There was no statistical significant difference in Scr and BUN levels in group B compared with those before treatment(P>0.05).There was no statistical significant difference in the total incidence of adverse reactions among the three groups(P>0.05).Conclusion The treatment of dapagliflozin combined with metformin in patients with T2DM complicated with visceral fat obesity can reduce the weight of patients by lowering blood glucose,lowering blood lipid and improving the content of body components,and dapagliflozin can play a role in renal protection.The combination has no obvious effect on liver and kidney function,and has certain safety.