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 in Group A including hypoglycemic reaction, thrombocytopenia and recrudescence o f HBV was 4.5% when compared to only one case of thrombocytopenia in Group B (0 .87%). Conclusions Both domestic Nateglinide and Repaglinide have similar effect on reducing postprandial blood glucose, but Repaglinide has stronger effect on reducing FBG and A1c than Nateglinide. The r esults suggest that both domestic Nateglinide and Repaglinide are safe and gener ally well-tolerated in type 2 diabetic patients.
出处
《中国循证医学杂志》
CSCD
2004年第7期446-452,共7页
Chinese Journal of Evidence-based Medicine
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
Na teglinide
Repaglinide
Type 2 diabetes mellitus
Randomized controlled trial
D rug treatment
