CAJ | 학술논문

目的比较那格列奈与阿卡波糖在2型糖尿病(T2DM)患者中的有效性及耐受性.方法随机、双盲、双模拟、平行组、多中心临床研究.237例单纯饮食治疗血糖控制不佳[糖化血红蛋白(HbA1c)6.5%～11.0%]的T2DM患者,随机给予那格列奈(120 mg,3次/d,119例)或阿卡波糖(100 mg,3次/d,118例)治疗12周.结果与基线相比,治疗后两组患者HbA1c、空腹血糖(FPG)、餐后2 h血糖(PG2h)及体重均显著降低(P<0.01);HbA1c与皋线相比的变化,那格列奈组为(-0.90±0.98)%,阿卡波糖组为(-0.83±0.81)%,两组差异无统计学意义(P>0.05);FPG与基线相比的变化,两组差异亦无统计学意义(P>0.05),PG2h与基线相比的变化,那格列条组与阿卡波糖组分别为(-1.45±2.74)mmol/L、(-2.20±2.21)mmol/L(P=0.0017),体重与基线相比,那格列奈组与阿卡波糖组分别为(-0.66±1.79)kg、(-2.06±2.00)kg,P=0.0000.两组可能与研究药物相关的不良反应例数及比例差异无统计学意义.结论那格列奈(120 mg,3次/d)在单纯饮食治疗血糖控制不佳的T2DM患者中疗效肯定,与阿卡波糖(100 mg,3次/d)降低HbA1c疗效相当,且耐受性良好.
목적 비교나격렬내여아잡파당재2형당뇨병(T2DM)환자중적유효성급내수성.방법 수궤、쌍맹、쌍모의、평행조、다중심림상연구.237례단순음식치료혈당공제불가[당화혈홍단백(HbA1c)6.5%～11.0%]적T2DM환자,수궤급여나격렬내(120 mg,3차/d,119례)혹아잡파당(100 mg,3차/d,118례)치료12주.결과 여기선상비,치료후량조환자HbA1c、공복혈당(FPG)、찬후2 h혈당(PG2h)급체중균현저강저(P<0.01);HbA1c여고선상비적변화,나격렬내조위(-0.90±0.98)%,아잡파당조위(-0.83±0.81)%,량조차이무통계학의의(P>0.05);FPG여기선상비적변화,량조차이역무통계학의의(P>0.05),PG2h여기선상비적변화,나격렬조조여아잡파당조분별위(-1.45±2.74)mmol/L、(-2.20±2.21)mmol/L(P=0.0017),체중여기선상비,나격렬내조여아잡파당조분별위(-0.66±1.79)kg、(-2.06±2.00)kg,P=0.0000.량조가능여연구약물상관적불량반응례수급비례차이무통계학의의.결론 나격렬내(120 mg,3차/d)재단순음식치료혈당공제불가적T2DM환자중료효긍정,여아잡파당(100 mg,3차/d)강저HbA1c료효상당,차내수성량호.
Objective To compare the efficacy and tolerability of nateglinide with those of acarbose in Chinese type 2 diabetes mellitus (T2DM) patients.Methods This multi-center,randomized,double-blind,parallel-arm study compared the efficacy and tolerability of nateglinide( 120 mg,3/d,n = 119) and those of acarbose( 100 mg,3/d,n = 118) during a 12-week treatment in T2DM patients uncontrolled by diet with glycosylated haemoglobin (HbA1c) 6.5% - 11.0% .Results Monotherapy with nateglinide (120 mg,3/d)or acarbose (100 mg,3/d)decreased HbA1c to a similar extent during 12-week treatment.The mean change from baseline to end-point in HbAlc was ( -0.90±0.98)% and ( -0.83±0.81 )% in patients receiving nateglinide and acarbose,respectively,with no significant difference between the two groups (P>0.05).The decrease in fasting plasma glucose (FPG)was similar between nateglinide and acarbose (P > 0.05).The mean change in 2-hour postprandial plasma glucose ( PG2h ) was ( - 1.45 ± 2.74) mmol/L and ( -2.20±2.21 ) mmol/L in patients receiving nateglinide and acarbose(P =0.0017).Body weight was significantly decreased in both groups at the end-point ( P < 0.05 ),although the decrease was more with acarbese than nateglinide [( -0.66±1.79)kg vs (-2.06±2.00) kg,P=0.0000].And the proportion of patients experiencing any presumed drug related adverse events was not significantly different between the two groups.Conclusions Nateglinide ( 120 mg,3/d) is effective and well tolerated in T2DM patients uncontrolled by diet,demonstrating similar HbA1c reductions as compared with acarbose (100 mg,3/d).