那格列奈治疗2型糖尿病的有效性与安全性

Efficacy and safety of domestic nateglinide tablet in type 2 diabetes

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。方法采用随机对照双盲双模拟临床试验方法,收集60例2型糖尿病患者,随机分为试验组30例,口服那格列奈片120 mg,tid;对照组30例,口服国产瑞格列奈片1 mg,tid,经2wk平衡期后进入治疗期,疗程12 wk。结果与用药前比较,治疗12 wk时,2组空腹血糖均下降,但无统计学意义;2组PBG治疗后与治疗前相比,差异有显著意义(P<0.05)。那格列奈组餐后1 h胰岛素增加,与治疗前相比有统计学意义。结论那格列奈120 mg,tid与瑞格列奈片1 mg,tid降低FBG疗效相当,国产那格列奈能有效降低患者PBG及HbA1c。

AIM To evaluate efficacy and safety of domestic nateglinide tablet in comparison with domestic repaglinide in type 2 diabetic patients. METHODS Sixty type 2 diabetic patients were randomly assigned to therapy group （domestic nateglinide,120 nag tid, n = 30） and control group（domestic repaglinide, 1 mg tid, n = 30）. The trial consisted of 2 wk equilibrated period followed by 12 wk treatment course. RESULTS The mean of fasting blood glucose （FBG） in both 2 groups were decreased duration at wk 12, but there was no statistically significant difference between 2 groups（ P 〉 0.05） ;The mean of postprandial blood glucose （PBG） were reduced in therapy group and control group. There was statistically significant difference of PBG between 2 groups （ P 〈 0.05 ）. CONCLUSION The effect of nateglinide 120 mg, tid equals to repaglinide 1 mg, tid in type 2 diabetes mellitus. Nateglinide can reduce PBG and HbA1c effectively.