国产那格列奈与瑞格列奈治疗2型糖尿病的多中心随机对照双盲双模拟临床试验  

Comparison of Efficacy and Safety of the Domestic Nateglinide with Repaglinide on Type 2 Diabetes Mellitus-Multi-Centre, Double-Blind, D ummy, Randomised Clinical Trial

作　　者：田浩明[1] 李启富[2] 王乃尊[3] 吴桐[4] 刘雅[5] 倪宗瓒[6] 喻红玲[1] 李健薇[1] 罗蓉[2] 黎英荣[3] 黄恋川[4] 夏彦[6] 

机构地区：[1]四川大学华西医院内分泌科,成都610041 [2]重庆医科大学附属第一医院内分泌科,重庆430000 [3]广西医科大学附属医院内分泌科,广西530000 [4]成都市第一人民医院内分泌科 [5]成都市第二人民医院 [6]四川大学公共卫生学院卫生统计学教研室

出　　处：《中国循证医学杂志》2004年第7期446-452,共7页Chinese Journal of Evidence-based Medicine

摘　　要：目的　评价国产那格列奈片治疗 2型糖尿病的有效性和安全性 ,并与阳性对照药国产瑞格列奈比较。　方法　采用多中心随机对照双盲双模拟临床试验方法 ,从 5个临床中心征集 2 30例 2型糖尿病患者 ,随机分为国产瑞格列奈片 (孚来迪 )组 (A组 ,1mgtid ,115例 )和国产那格列奈片组 (B组 ,90mgtid ,115例 )进行治疗和比较 ,疗程为 12周。治疗前 4周为平衡期。　结果　共有 2 2 3例 (96 9% )完成了试验 ,其中A组 110例 ,B组 113例。①与用药前相比 ,用药后A、B两组空腹血糖于第 2、6、12周均有明显下降 (P <0 0 0 0 1)。第 12周时A、B两组空腹血糖平均下降值分别为 1 6 8± 1 81mmol/L (17 2 7% )和 1 17± 1 6 7mmol/L (12 5 3% ) ,两组间比较其差异有统计学意义 (P =0 0 177)。说明A组用药剂量对空腹血糖的降低作用大于B组所用的药物剂量。②在用药后第 2、6、12周 ,A、B两组餐后 12 0min血糖水平均有明显下降 ,下降幅度相似 ,两组间差异无统计学意义。第 12周时A、B两组餐后 30、6 0、12 0min血糖水平较用药前均有显著降低 ,其中餐后 12 0min血糖水平较用药前下降 3 95± 3 2 5mmol/L (2 6 12 % ) ,B组下降 3 81± 3 0 5mmol/L(2 6 2 2 % ) ,两组下降值差异无统计学意义 (P =0 72 6 9)。③用药后 12?Objective To evaluate efficacy and safety of domestic Nateglinide tablet in comparison with domestic Repaglinide in Type 2 diabeties. Method s A multi-centre, double-blind, dummy trial was conduct e d.Two hundred and thirty type 2 diabetic patients recuited from 5 clinical cent ers were randomly allocated into Group A (domestic Repaglinide, 1.0 mg tid, and Group B (domestic Nateglinide, 90 mg tid, .The trial consisted of a 4 weeksequilibrated period followed b y 12 weeks treatment course .Results Ninety s even percent of patients(223) completed the trial (110 in Group A and 113 in Gr oup B). The mean of fasting blood glucose (FBG) in both Group A and B was decre ased statistically ( P< 0.000 1) after 2, 6 and 12 weeks durat ion. At week 12, the mean FBG in Group A and B was reduced by 1.68±1.81 mmol /L (17.27%) and 1.17±1.67 mmol/L (12.53%) respectively with statistically s ignificant difference between the two groups( P=0.017 7). The mean of 120 minutes postprandial blood glucose(PBG) also lowered markedly in 2, 6, and 12 weeks in both groups. At the end of therapy, PBG of 30, 60, 120 m inutes were reduced significantly, mean of 120 minutes PBG was reduced 3.95±3 .25 mmol/L (26.12%), and 3.81±3.05 mmol/L (26.22%) respectively in Group A and B , the differences in reduction between Group A and B had no statistical s ignificance (P=0.726 9). In Group A and B, the mean of Alc was reduced significantly after 12 weeks duration. At week 12, the mean of Alc in Group A and B was lowered by 1.21% and 0.68% respectively, with statistical di fference between the two groups (P0.002 3). Though fasti ng insulin level in both groups had no change after 12 weeks duration, the insul in level at 30, 60 and 120 min increased significantly in both groups ( P<0.000 1). It suggested that both Nateglinide and Repaglinide promot ed insulin secretion in early phase with maximal value at 60 min in Repaglinide group and 30 min in Nateglinide group, respectively. The adverse reaction rate

关 键 词：那格列奈 瑞格列奈 2型糖尿病 随机对照试验 药物治疗 

分 类 号：R587.1[医药卫生—内分泌]