CAJ | 학술논문

目的探讨西格列汀和二甲双胍单药及联合治疗对2型糖尿病(T2DM)的疗效及对胰岛功能的影响.方法将2011年1月至2012年12月收治的60例初治T2DM患者,按随机数字表法分为3组,西格列汀治疗组(S组,西格列汀100 mg每天1次)、二甲双胍治疗组(M组,二甲双胍500 mg每天3次)及西格列汀、二甲双胍联合治疗组(SM组,西格列汀100 mg每天1次+二甲双胍500 mg每天3次),每组20例.治疗12周后,比较三组治疗前后空腹血糖(FBG)、餐后2h血糖(2 hPG)、糖化血红蛋白(HbA1c)、血压、血脂及稳态模型β细胞功能指数(HOMA-β)、稳态模型胰岛素抵抗指数(HOMA-IR)等指标的变化,并观察体质指数(BMI)、药物不良反应发生况.治疗前后比较采用配对t检验,组间比较采用方差分析.结果治疗后,三组血糖、HbA1c、血甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、血压及HOMA-IR均较治疗前明显下降,而HOMA-β均明显升高,差异均有统计学意义(均P ＜0.05).治疗后,S组与M组各项指标差异均无统计学意义(均P＜0.05).SM组HbA1c(6.1％±0.5％)相较于S组(6.6％±0.5％)及M组(6.5％±0.6％)下降更为显著(F=4.964,P＜0.05),血糖、TG、TC、LDL-C及血压亦显著下降(均P＜0.05).与S组(65±18)及M组(63±23)相比,SM组HOMA-β(83±27)显著升高(F=4.349,P＜0.05).治疗后三组HOMA-IR差异无统计学意义(F=0.149,P＞0.05).S组治疗前后BMI无显著变化,M组及SM组治疗后BMI较前显著下降(均P＜0.05),与S组比较差异均有统计学意义(均P＜0.05).三组均未出现严重低血糖事件.结论西格列汀起始单药治疗2型糖尿病对血糖的控制及胰岛β细胞功能的改善与二甲双胍相似,而两者联合用药效果更佳,且耐受性良好.
목적 탐토서격렬정화이갑쌍고단약급연합치료대2형당뇨병(T2DM)적료효급대이도공능적영향.방법 장2011년1월지2012년12월수치적60례초치T2DM환자,안수궤수자표법분위3조,서격렬정치료조(S조,서격렬정100 mg매천1차)、이갑쌍고치료조(M조,이갑쌍고500 mg매천3차)급서격렬정、이갑쌍고연합치료조(SM조,서격렬정100 mg매천1차+이갑쌍고500 mg매천3차),매조20례.치료12주후,비교삼조치료전후공복혈당(FBG)、찬후2h혈당(2 hPG)、당화혈홍단백(HbA1c)、혈압、혈지급은태모형β세포공능지수(HOMA-β)、은태모형이도소저항지수(HOMA-IR)등지표적변화,병관찰체질지수(BMI)、약물불량반응발생황.치료전후비교채용배대t검험,조간비교채용방차분석.결과 치료후,삼조혈당、HbA1c、혈감유삼지(TG)、총담고순(TC)、저밀도지단백담고순(LDL-C)、혈압급HOMA-IR균교치료전명현하강,이HOMA-β균명현승고,차이균유통계학의의(균P ＜0.05).치료후,S조여M조각항지표차이균무통계학의의(균P＜0.05).SM조HbA1c(6.1％±0.5％)상교우S조(6.6％±0.5％)급M조(6.5％±0.6％)하강경위현저(F=4.964,P＜0.05),혈당、TG、TC、LDL-C급혈압역현저하강(균P＜0.05).여S조(65±18)급M조(63±23)상비,SM조HOMA-β(83±27)현저승고(F=4.349,P＜0.05).치료후삼조HOMA-IR차이무통계학의의(F=0.149,P＞0.05).S조치료전후BMI무현저변화,M조급SM조치료후BMI교전현저하강(균P＜0.05),여S조비교차이균유통계학의의(균P＜0.05).삼조균미출현엄중저혈당사건.결론 서격렬정기시단약치료2형당뇨병대혈당적공제급이도β세포공능적개선여이갑쌍고상사,이량자연합용약효과경가,차내수성량호.
Objective To assess the effects of monotherapy and combination therapy with sitagliptin and metformin on blood glucose control and β-cell function in type 2 diabetes mellitus (T2DM).Methods Sixty drug-na(i)ve T2DM patients treated from January 2011 to December 2012 were randomized to receive sitagliptin monotherapy(S group:100 mg q.d),metformin monotherapy(M group:500 mg t.i.d) and combination therapy of sitagliptin and metformin (SM group:sitagliptin 100 mg q.d + metformin 500 mg t.i.d) for 12 weeks according to random number table.Fasting plasma glucose(FBG),2-hour postprandial blood glucose (2hPG),glycated hemoglobin A 1 c (HbA1 c),body mass index (BMI),triglyceride (TG),total cholesterol (TC),low density lipoprotein-cholesterol (LDL-C),blood pressure (BP),homeostatic model assessment of the insulin secretion index (HOMA-β) and insulin resistance index (HOMA-IR) were measured before and after the treatment.The incidence of hypoglycemia and drug adverse reaction was also observed during the treatment.The Student's t test and analysis of variance was used when data was compared before and after treatment and among groups.Results After intervention,FPG,2hPG,HbA1c,TG,TC,LDL-C,blood pressure and HOMA-IR decreased significantly,while HOMA-β increased significantly in all three groups(all P ＜ 0.05).Significant difference of glucose profile and β-cell function was not observed between M group and S group.The HbA1c decreased further in SM group (6.1％ ± 0.5％) when compared with S group (6.6％ ± 0.5％) and M group (6.5％ ± 0.6％) (F =4.964,P =0.01).The HOMA-β in SM group(83 ±27) was significant higher than those in S group (65 ± 18) and M group (63 ± 23) after treatment (F =4.349,P =0.017).In addition,TG,TC,LDL-C and blood pressure also decreased further in SM group,while HOMA-IR didn't compared with S group or M group(F =0.149,P ＞ 0.05).BMI in M group and SM group decreased significantly after treatment but there was no significant change in S group.No severe hypoglycemic events occurred in all groups.Conclusion Sitagliptin has similar effect on glycemic control as metformin.Better glucose profile is observed when patients receiving combination therapy.