利拉鲁肽和西格列汀对超重和肥胖2型糖尿病患者的疗效和安全性比较
리랍로태화서격렬정대초중화비반2형당뇨병환자적료효화안전성비교
Comparison of efficacy and safety between liraglutide and sitagliptin in overweight and obese type 2 diabetes patients
  • 万方数据
    中华糖尿病杂志 중화당뇨병잡지
    CHINES JOURNAL OF DLABETES MELLITUS
    2014年 3期 157-162 ,共6页

    陈睿%于珮%李春君%吕琳%马泽军%刘向阳%马君%李卫东%陈莉明

    진예%우패%리춘군%려림%마택군%류향양%마군%리위동%진리명

    利拉鲁肽%糖尿病,2型%西格列汀%二甲双胍%肥胖 利拉魯肽%糖尿病,2型%西格列汀%二甲雙胍%肥胖
    리랍로태%당뇨병,2형%서격렬정%이갑쌍고%비반
    Liraglutide%Diabetes mellitus,type 2%Sitagliptin%Metformin%Obesity
    目的 比较利拉鲁肽和西格列汀与二甲双胍联合应用时对超重和肥胖的2型糖尿病患者疗效和安全性.方法 选取2012年4月至10月住院的体质指数(BMI)＞25 kg/m2的2型糖尿病患者86例,按随机数字表法分为利拉鲁肽治疗组(40例)和西格列汀治疗组(46例),于用药前、用药4周、12周和24周后分别测定患者的空腹静脉血糖(FPG)、餐后2h血糖(PPG)、糖化血红蛋白(HbA1c)、体重、腰围、血压、甘油三酯(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、肝功能、肾功能、24 h尿微量白蛋白(UMA).记录用药期间的低血糖发生情况和其他不良反应.采用t检验和重复测量资料方差分析进行数据分析.结果 (1)两组患者的血糖和HbA1c在治疗后均出现下降,但两组间差别无统计学意义(均P＞0.05).(2)利拉鲁肽组患者用药24周后体重较用药前下降[(80±7)比(85 ±8)kg,t=2.9,P＜0.05],西格列汀组患者用药24周后体重较用药前下降[(82±7)比(84±7) kg,t =2.78,P＜0.05]；用药24周后两组间差别有统计学意义[(80±7)比(82 ±7) kg,t=-3.5,P＜0.05].(3)利拉鲁肽组患者用药24周后较用药前腰围下降[分别为(101±7)比(106±8)cm,t =13.35,P＜0.05],西格列汀组用药24周后腰围较用药前减少[分别为(102 ±6)比(105 ±6) cm,t =3.3,P＜0.05],用药24周后两组间差别有统计学意义[(101±7)比(102±6)cm,t=-3.1,P＜0.05].(4)利拉鲁肽组患者用药24周后收缩压较用药前下降[(138±7)比(143±6) mmHg,1 mmHg=0.133 kPa,=3.69,P＜0.05],西格列汀组用药24周后较用药前收缩压下降[(139±4)比(141 ±5) mmHg,t=2.8,P＜0.05],用药24周后两组间差异有统计学意义[(138±7)比(139 ±4) mm Hg,t=-3.0,P＜0.05]；利拉鲁肽组患者用药4周后较用药前舒张压下降[(89±2)比(93±2)mmHg,t=2.6,P＜0.05],西格列汀组用药24周后较用药前舒张压下降[(89±3)比(92±3)mmHg,t=3.5,P＜0.05],两组间差异无统计学意义(P＞0.05).(5)利拉鲁肽组患者的上消化道不良反应多于西格列汀组,差异具有统计学意义(30.0％比4.3％,=2.86,P＜0.05).结论 利拉鲁肽联合二甲双胍与西格列汀联合二甲双胍降低超重和肥胖的2型糖尿病患者的即时血糖和HbA1c的能力相同,利拉鲁肽能够更有效地降低患者体重、腰围和血压,西格列汀具有良好的安全性.
    목적 비교리랍로태화서격렬정여이갑쌍고연합응용시대초중화비반적2형당뇨병환자료효화안전성.방법 선취2012년4월지10월주원적체질지수(BMI)＞25 kg/m2적2형당뇨병환자86례,안수궤수자표법분위리랍로태치료조(40례)화서격렬정치료조(46례),우용약전、용약4주、12주화24주후분별측정환자적공복정맥혈당(FPG)、찬후2h혈당(PPG)、당화혈홍단백(HbA1c)、체중、요위、혈압、감유삼지(TG)、총담고순(TC)、고밀도지단백담고순(HDL-C)、저밀도지단백담고순(LDL-C)、간공능、신공능、24 h뇨미량백단백(UMA).기록용약기간적저혈당발생정황화기타불량반응.채용t검험화중복측량자료방차분석진행수거분석.결과 (1)량조환자적혈당화HbA1c재치료후균출현하강,단량조간차별무통계학의의(균P＞0.05).(2)리랍로태조환자용약24주후체중교용약전하강[(80±7)비(85 ±8)kg,t=2.9,P＜0.05],서격렬정조환자용약24주후체중교용약전하강[(82±7)비(84±7) kg,t =2.78,P＜0.05]；용약24주후량조간차별유통계학의의[(80±7)비(82 ±7) kg,t=-3.5,P＜0.05].(3)리랍로태조환자용약24주후교용약전요위하강[분별위(101±7)비(106±8)cm,t =13.35,P＜0.05],서격렬정조용약24주후요위교용약전감소[분별위(102 ±6)비(105 ±6) cm,t =3.3,P＜0.05],용약24주후량조간차별유통계학의의[(101±7)비(102±6)cm,t=-3.1,P＜0.05].(4)리랍로태조환자용약24주후수축압교용약전하강[(138±7)비(143±6) mmHg,1 mmHg=0.133 kPa,=3.69,P＜0.05],서격렬정조용약24주후교용약전수축압하강[(139±4)비(141 ±5) mmHg,t=2.8,P＜0.05],용약24주후량조간차이유통계학의의[(138±7)비(139 ±4) mm Hg,t=-3.0,P＜0.05]；리랍로태조환자용약4주후교용약전서장압하강[(89±2)비(93±2)mmHg,t=2.6,P＜0.05],서격렬정조용약24주후교용약전서장압하강[(89±3)비(92±3)mmHg,t=3.5,P＜0.05],량조간차이무통계학의의(P＞0.05).(5)리랍로태조환자적상소화도불량반응다우서격렬정조,차이구유통계학의의(30.0％비4.3％,=2.86,P＜0.05).결론 리랍로태연합이갑쌍고여서격렬정연합이갑쌍고강저초중화비반적2형당뇨병환자적즉시혈당화HbA1c적능력상동,리랍로태능구경유효지강저환자체중、요위화혈압,서격렬정구유량호적안전성.
    Objective This single center,randomized,open-label study was aimed to compare the efficacy and safety of liraglutide and sitagliptin in over-weight and obese type 2 diabetic patients.Methods Eighty-six type 2 diabetes in-patients with body mass index(BMI) ＞ 25 kg/m2 from April to October 2012 were enrolled.Subjects were numberally randomly assigned to liraglutide group (n =40) or sitagliptin group (n =46),and all receiving metformin (1 000 mg/d) simultaneously.Fasting plasma glucose (FPG),postprandial plasma glucose (PPG),HbA1c,body weight,waistline,blood pressure,triglyceride (TG),total cholesterol (TC),high density lipoprotein-cholesterol (HDL-C),low density lipoprotein-cholesterol (LDL-C),live function,kidney function and 24-hour urine microalbumin (UMA) of each patient were measured before and 4,12,24 weeks after treatment.Incidence of hypoglycemia and other side effects are recorded during treatment.T test and repeat measurement data variance analysis were used to analyze the data.Results (1) Compared to the baseline,after 24-week treatment,the levels of FPG,PPG and HbA1c were all decreased in liraglutide group,as well as in sitagliptin group.No difference was shown between the two groups (all P ＞ 0.05).(2) Body weight reduced in liraglutide group ((80 ± 7) vs (85 ± 8) kg,t =2.9,P ＜ 0.05) and in sitagliptin group ((82 ± 7) vs (84 ± 7) kg,t =2.78,P ＜ 0.05).There was statistical significance between the two groups after 24-week treatment (t =-3.5,P ＜ 0.05).(3) The mean waist circumference reduction in liraglutide group was ((101 ± 7) vs (106 ± 8) cm,t =13.35,P ＜ 0.05) greater than in sitagliptin group ((102 ± 6) vs (105 ± 6) cm,t =3.3,P ＜ 0.05).There was statistical significance between the two groups (t =-3.1,P ＜ 0.05).(4) After 24-week treatment,SBP of liraglutide group decreased from (143 ± 6) to (138± 7) mmHg(1 mmHg =0.133 kPa,t =3.69,P ＜ 0.05),while that of sitagliptin group decreased from (141 ±5) to (139 ±4) mmHg.There was statistical significance between the two groups (t =2.8,P ＜ 0.05).We can see statistical difference of SBP between two groups at week 24 (t =-3.1,P ＜ 0.05).After 24-week treatment,DBP of liraglutide group decreased from (93 ± 2) to (89 ± 2) mmHg (t =2.6,P ＜ 0.05).while that of sitagliptin group decreased from (92 ± 3) to (89 ± 3) mmHg (t =3.5,P ＜ 0.05).But there was no significant difference in DBP between the two groups (t =1.64,P ＞ 0.05).(5) More people in liraglutide group felt gastrointestinal discomfort than in sitagliptin group (30％ vs 4.3 ％,t =2.86,P ＜ 0.05).Conclusions Our results imply liraglutide with metformin and sitagliptin with metformin has equal capability of reduction of blood glucose and HbAlc.The former one is superior to the latter one on control of body weight,waistline and blood pressure,and sitagliptin leads to fewer gastrointestinal effects than liraglutide.
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