CAJ | 학술논문

目的评估艾塞那肽与双时相门冬胰岛素30在口服降糖药控制不佳的肥胖2型糖尿病患者中的疗效及安全性.方法选取2010年2月至8月就诊的2型糖尿病患者,年龄＞35岁,体质指数(BMI)＞25 kg/m2,腰围男＞90cm,女＞85 cm,糖化血红蛋白(HbA1c)为7.5%～10.5%,二甲双胍与磺脲类降糖药治疗达12个月以上,二甲双胍剂量至少达1000 mg/d,磺脲类剂量达最大剂量一半以上.4周进入期结束后,按随机、开放、平行分组法,将符合人选条件的80例受试者分入艾塞那肽组(试验组,n=40)与双时相门冬胰岛素30组(对照组,n=40),进行为期16周的临床观察.统计学分析采用t检验或X2检验.结果 16周时,试验组(36例)与对照组(37例)HbA1c分别为(7.6±0.9)%、(7.2±1.0)%,较基线时[(9.0±1.1)%、(9.2±1.0)%]降低(t=-3.6,P＜0.01);试验组与对照组HbA1c降至6.5%的比例分别为16.7%和37.8%(X2=4.1,P＜0.05),HbAlc降至7.0%的比例分别为47.2%与54.1%(X2=0.3,P=0.6).试验组体质量减轻(3.4±1.7)kg,对照组体质量增加(2.7±1.4)kg.16周时,试验组8例受试者发生24例次低血糖事件,无重大低血糖事件发生.对照组15例发生60次低血糖,2例因重大低血糖事件、2例因反复夜间低血糖而中止试验.试验组消化道不良事件更多见.试验组收缩压、血脂改善较对照组显著(均P＜0.05),两组舒张压、血同型半胱氨酸的差异无统计学意义(均P＞0.05).结论艾塞那肽在控制体质量、改善血脂代谢、降低低血糖风险上存在优势.
목적 평고애새나태여쌍시상문동이도소30재구복강당약공제불가적비반2형당뇨병환자중적료효급안전성.방법 선취2010년2월지8월취진적2형당뇨병환자,년령＞35세,체질지수(BMI)＞25 kg/m2,요위남＞90cm,녀＞85 cm,당화혈홍단백(HbA1c)위7.5%～10.5%,이갑쌍고여광뇨류강당약치료체12개월이상,이갑쌍고제량지소체1000 mg/d,광뇨류제량체최대제량일반이상.4주진입기결속후,안수궤、개방、평행분조법,장부합인선조건적80례수시자분입애새나태조(시험조,n=40)여쌍시상문동이도소30조(대조조,n=40),진행위기16주적림상관찰.통계학분석채용t검험혹X2검험.결과 16주시,시험조(36례)여대조조(37례)HbA1c분별위(7.6±0.9)%、(7.2±1.0)%,교기선시[(9.0±1.1)%、(9.2±1.0)%]강저(t=-3.6,P＜0.01);시험조여대조조HbA1c강지6.5%적비례분별위16.7%화37.8%(X2=4.1,P＜0.05),HbAlc강지7.0%적비례분별위47.2%여54.1%(X2=0.3,P=0.6).시험조체질량감경(3.4±1.7)kg,대조조체질량증가(2.7±1.4)kg.16주시,시험조8례수시자발생24례차저혈당사건,무중대저혈당사건발생.대조조15례발생60차저혈당,2례인중대저혈당사건、2례인반복야간저혈당이중지시험.시험조소화도불량사건경다견.시험조수축압、혈지개선교대조조현저(균P＜0.05),량조서장압、혈동형반광안산적차이무통계학의의(균P＞0.05).결론애새나태재공제체질량、개선혈지대사、강저저혈당풍험상존재우세.
Objective To investigate the efficacy and safety of exenatide versus biphasic insulin aspart 36(BIAsp30) in patients with inadequately glycemic controlled and obese type 2 diabetes with oral antidiabetes agents.Methods A single center, randomized, open-label, parallel-group study was conducted.Four weeks run-in period and 16 weeks treatment period were included.Eighty subjects were enrolled( ( ＞35 years old, BMI ＞ 25 kg/m2 ), waist circumference( male ＞ 90 cm and female ＞ 85 cm),HbA1c 7.5%-10.5% ).All subjects which received metformin (at least 1000 mg/d) or sulfonylurea (at least half the maximal dose) for at least 12 months were randomly assigned to exenatide group( n =40) or BIAsp30 group ( n = 40) twice or thrice daily.The t and X2 test was used in the data analysis.Results Compared to the baseline, the HbAlc values decreased in exenatide group(7.6% ±0.9% )and in BIAsp30 group(7.2% ± 1.0% ) after 16 weeks treatment ( t = - 3.6, P ＜ 0.01 ).The proportion of patients which HbA1c less than 6.5% was 37.8% ( BIAsp30 group) and 16.7% ( exenatide group, X2 =4.1, P ＜0.05 ).The proportion of patients which HbA1 c less than 7.0% was 47.2% and 54.1 %, respectively ( X2 = 0.3,P ＞ 0.05 ).Weight gain was observed for the BIAsp30 group (2.7 ± 1.4) kg while weight loss was reported for the exenatide group (3.4 ± 1.7 ) kg.The amount of subjects reporting hypoglycemic events was significantly greater in BIAsp30 group than in exenatide group (4.88 vs 1.95 events/subject per year).The reductions of systolic blood pressure ,and the improvement of lipid profile in exenatide group were superior to that of BIAsp30 group.However, There was no significant difference on diastolic blood pressure and homocysteic acid between the two groups ( P ＞ 0.05 ).Conclusions Eexenatide is superior on reduction of hypoglycemic events, control weight, and improvement of lipid parameters to BIAsp30.