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目的探讨瑞格列奈对于未接受过口服降糖药治疗的中重度初诊2型糖尿病患者(HbA1c>8.5%)的疗效和安全性。方法入选未接受过口服降糖药治疗的中重度初诊2型糖尿病患者46例,随机分为2组。联合组23例用瑞格列奈和二甲双胍口服,单药组23例用瑞格列奈单独口服。观察治疗前后糖化血红蛋白(HbA1c)、空腹血糖(FBG)、餐后2 h血糖(PBG)、体质量、常规安全性指标和低血糖事件,并进行两组之间的比较。结果瑞格列奈单独或联合二甲双胍治疗后体质量没有明显变化,FBG降低2.8 mmol·L~(-1)(P<0.01),PBG降低5.2 mmol·L~(-1)(P<0.01),HbA1c降低3.9%(P<0.01),血糖的达标率为81.8%。联合组瑞格列奈中位数剂量每日3 mg,单药组瑞格列奈中位数剂量每日6 mg,联合组瑞格列奈用量显著低于单药组(P<0.05)。结论对于未接受过口服降糖药治疗的中重度(HbA1c>8.5%)初诊2型糖尿病患者,采用瑞格列奈单独或联合二甲双胍治疗能够有效和安全地降低HbA1c,降低FBG和PBG,以PBG为著;联合二甲双胍治疗能够减少瑞格列奈的剂量。
Objective To investigate the efficacy and safety of repaglinide in patients with moderate-severe newly diagnosed type 2 diabetes (HbA1c> 8.5%) who did not receive oral hypoglycemic agents. Methods Forty-six patients with moderate-severe newly diagnosed type 2 diabetes who were not treated with oral hypoglycemic agents were randomly divided into two groups. Twenty-three patients in the combination group were treated with repaglinide and metformin orally, and 23 patients in the single drug group were treated with repaglinide alone. The levels of HbA1c, fasting blood glucose (FBG), postprandial 2h blood glucose (PBG), body weight, routine safety and hypoglycaemic events were observed before and after treatment. The comparisons between the two groups were made. Results There was no significant change in the body weight of repaglinide alone or in combination with metformin. FBG decreased by 2.8 mmol·L -1 (P <0.01) and PBG decreased by 5.2 mmol·L -1 (P <0.01) , HbA1c decreased by 3.9% (P <0.01), blood glucose compliance rate was 81.8%. In the combination group, the median dose of repaglinide was 3 mg daily, the median dose of repaglinide in single drug group was 6 mg daily, and the dosage of repaglinide in combination group was significantly lower than that in single drug group (P <0.05). Conclusions For patients with newly diagnosed type 2 diabetes who did not receive oral hypoglycemic agents (HbA1c> 8.5%), treatment with repaglinide alone or in combination with metformin effectively and safely reduced HbA1c, decreased FBG and PBG, and PBG As the combination of metformin can reduce the dose of repaglinide.