CAJ | 학술논문

目的观察单用二甲双胍血糖控制不佳的新诊断2型糖尿病患者加用沙格列汀降糖的有效性及安全性.方法 180例单用二甲双胍12周,血糖不达标的新诊断2型糖尿病患者,简单随机化分为沙格列汀组与阿卡波糖组,每组各90例,进行12周的随访,观察空腹血糖、餐后2h血糖(2 hPG)、HbA1c、HbA1c达标率、空腹胰岛素、稳态模型评估-胰岛素抵抗指数(HOMA-IR)、体重指数等指标的变化,记录低血糖、胃肠道不良反应的发生情况.结果治疗12周后,沙格列汀组与阿卡波糖组空腹血糖、2 hPG和HbA1c较治疗前明显降低[下降值分别为(1.98 ±0.67)、(1.85±0.78)mmol/L,(2.62±1.21)、(2.22±1.31)mmol/L,(0.97±0.48)％、(0.82±0.52)％,t=1.994,2.074,2.010,P均＜0.05]；沙格列汀组2 hPG及HbAlc较阿卡波糖组下降幅度大(t=-2.711,-2.600,P均＜0.05)；沙格列汀组HbA1c达标率高于阿卡波糖组(83.33％比67.78％,x2=5.870,P＜0.05)；沙格列汀组与阿卡波糖组空腹胰岛素水平较治疗前升高[升高值分别为(1.07±0.59)、(0.47±0.32) mU/L,t=8.480,P＜0.05]；HOMA-IR较治疗前明显下降(下降值分别为0.42 ±0.27、0.25±0.38,t=3.459,P＜0.05)；沙格列汀组空腹胰岛素水平及HOMA-IR的改善优于阿卡波糖组(t=3.451,-3.359,P均＜0.05)；两组治疗前、后体重、体重指数、低血糖发生率、肝功能、肾功能及血脂水平差异无统计学意义(P均＞0.05)；阿卡波糖组胃肠道不良反应发生率显著高于沙格列汀组；沙格列汀组患者服药依从性优于阿卡波糖组(x2=8.760,P＜0.05).结论沙格列汀与二甲双胍联用治疗新诊断的2型糖尿病患者降糖效果好,不影响体重、肝功能、肾功能及血脂水平,低血糖及胃肠道不良反应发生率低,患者依从性好.
목적 관찰단용이갑쌍고혈당공제불가적신진단2형당뇨병환자가용사격렬정강당적유효성급안전성.방법 180례단용이갑쌍고12주,혈당불체표적신진단2형당뇨병환자,간단수궤화분위사격렬정조여아잡파당조,매조각90례,진행12주적수방,관찰공복혈당、찬후2h혈당(2 hPG)、HbA1c、HbA1c체표솔、공복이도소、은태모형평고-이도소저항지수(HOMA-IR)、체중지수등지표적변화,기록저혈당、위장도불량반응적발생정황.결과 치료12주후,사격렬정조여아잡파당조공복혈당、2 hPG화HbA1c교치료전명현강저[하강치분별위(1.98 ±0.67)、(1.85±0.78)mmol/L,(2.62±1.21)、(2.22±1.31)mmol/L,(0.97±0.48)％、(0.82±0.52)％,t=1.994,2.074,2.010,P균＜0.05]；사격렬정조2 hPG급HbAlc교아잡파당조하강폭도대(t=-2.711,-2.600,P균＜0.05)；사격렬정조HbA1c체표솔고우아잡파당조(83.33％비67.78％,x2=5.870,P＜0.05)；사격렬정조여아잡파당조공복이도소수평교치료전승고[승고치분별위(1.07±0.59)、(0.47±0.32) mU/L,t=8.480,P＜0.05]；HOMA-IR교치료전명현하강(하강치분별위0.42 ±0.27、0.25±0.38,t=3.459,P＜0.05)；사격렬정조공복이도소수평급HOMA-IR적개선우우아잡파당조(t=3.451,-3.359,P균＜0.05)；량조치료전、후체중、체중지수、저혈당발생솔、간공능、신공능급혈지수평차이무통계학의의(P균＞0.05)；아잡파당조위장도불량반응발생솔현저고우사격렬정조；사격렬정조환자복약의종성우우아잡파당조(x2=8.760,P＜0.05).결론 사격렬정여이갑쌍고련용치료신진단적2형당뇨병환자강당효과호,불영향체중、간공능、신공능급혈지수평,저혈당급위장도불량반응발생솔저,환자의종성호.
Objective To assess the efficacy and safety of saxagliptin added to metformin in newly diagnosed patients with type 2 diabetes mellitus (T2DM) whose glycemic control were inadequate on metformin alone.Methods 180 Newly diagnosed T2DM patients having inadequately controlled on metfomin monotherapy for 12 weeks were simply randomly divided into saxagliptin group(n =90) and acarbose group (n =90),followed up for 12 weeks.The changes of fasting plasma glucose,two-hour postprandial plasma glucose (2 hPG),HbA1c,the targeting rate of HbA1c,fasting plasma insulin,homeostatic model assessment of insulin resistance index(HOMA-IR),body mass index and the incidence of hypoglycemia and gastro-intestinal adverse reactions in both groups were observed.Results After treatment for 12 weeks,the levels of fasting plasma glucose,2 hPG and HbAlc decreased [respectively(1.98 ± 0.67),(1.85 ± 0.78)mmol/L,(2.62 ± 1.21),(2.22 ± 1.31) mmol/L,(0.97 ± 0.48) ％,(0.82 ± 0.52) ％,t =1.994,2.074,2.010,all P ＜ 0.05].Compared with acarbose group,the levels of 2 hPG and HbA1c decreased significantly in saxagliptin group (t =-2.711,-2.600,all P ＜0.05).The targeting rate of HbA1c in saxagliptin group was higher than that in acarbose group (83.33 ％ vs.67.78％,x2 =5.870,P ＜ 0.05).The levels of fasting plasma insulin were increased in both groups [respectively (1.07 ± 0.59),(0.47 ± 0.32) mU/L,t =8.480,P ＜ 0.05].HOMA-IR were significantly decreased compared with baseline in both groups (respectively 0.42 ± 0.27,0.25 ± 0.38,t =3.459,P ＜ 0.05).Compared with acarbose group,the levels of fasting plasma insulin and HOMA-IR were significantly improved in saxagliptin group (t =3.451,-3.359,all P ＜0.05).The changes in weight,body mass index,the incidence of hypoglycemia,liver function,renal function and blood lipid of the two groups had no statistical differences (all P ＞ 0.05).Compared with acarbose group,saxaglipin group,had less gastrointestinal side effects and good compliance (x2 =8.760,P ＜ 0.05).Compared with acarbose group,saxagliptin group have better compliance(x2 =8.760,P ＜ 0.05).Conclusions The combination of metformin with saxagliptin is effective for the treatment of newly diagnosed T2DM patients,without influence on the body weight,liver function,renal function and blood lipid,with lower incidence of hypoglycemia and gastrointestinal side effects,and having good compliance.