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目的比较国产那格列奈和进口瑞格列耐治疗2型糖尿病的疗效和安全性。方法用双盲双模拟随机平行方法,210例患者经14周治疗,评价组内和组间的糖化血红蛋白、餐后血糖和安全性。结果治疗后,2组糖化血红蛋白和餐后2h血糖均显著降低。糖化血红蛋白:国产那格列奈组为(9.06±1.54)%vs(7.85±1.00)%(P<0.05);进口瑞格列耐组为(8.95±1.56)%vs(7.76±1.04)%(P<0.05)。餐后2h血糖:国产那格列奈组为(14.17±3.44)mmol·L-1vs(10.90±2.97)mmol·L-1(P<0.05);进口瑞格列耐组为(14.14±3.11)mmol·L-1vs(10.89±3.09)mmol·L-1(P<0.05)。治疗后,空腹血糖和胰岛素水平均有不同程度下降,但无统计学差异。药物不良反应主要为轻度低血糖。结论国产那格列奈与进口瑞格列耐均显著降低餐后血糖且无严重药物不良反应。
Objective To compare the efficacy and safety of domestic nateglinide and imported repaglinide in the treatment of type 2 diabetes mellitus. Methods A double-blind, double-dummy randomized parallel approach was used. 210 patients underwent 14 weeks of treatment to evaluate glycosylated hemoglobin (HbA1c), postprandial glucose and safety within and between groups. Results After treatment, two groups of glycosylated hemoglobin and 2h postprandial blood glucose were significantly reduced. HbA1c was (9.06 ± 1.54)% vs (7.85 ± 1.00)% in domestic nateglinide group (8.95 ± 1.56)% vs (7.76 ± 1.04)% (P <0.05) P <0.05). The blood glucose level at 2h after meal was (14.17 ± 3.44) mmol·L-1vs (10.90 ± 2.97) mmol·L-1 in domestic nateglinide group (14.14 ± 3.11) mmol·L-1vs (10.89 ± 3.09) mmol·L-1 (P <0.05). After treatment, fasting blood glucose and insulin levels have decreased to varying degrees, but no significant difference. Adverse drug reactions are mainly mild hypoglycemia. Conclusion Both domestic nateglinide and imported repaglinide significantly reduce postprandial blood glucose without serious adverse drug reactions.