那格列奈治疗2型糖尿病的疗效及安全性的临床试验

目的　对新型口服降糖药物———那格列奈的疗效及安全性进行评价。方法　将4 6例2型糖尿病患者随机分入那格列奈组和对照组(瑞格列奈组) ,进行为期12周的观察。测定指标包括空腹指尖血糖、空腹静脉血浆血糖、餐后2h指尖血糖、餐后2h静脉血浆血糖和HbA1c等。结果　①那格列奈治疗12周后患者空腹血浆血糖、餐后2h血浆血糖及HbA1c均有显著下降,均值分别下降1.6 3mmol/L、4 .4 3mmol/L、1.71% ,差异有统计学意义。②治疗后两组间空腹血浆血糖及餐后2h血浆血糖比较差异无统计学意义。③与治疗前比较,那格列奈治疗后血胆固醇、血压及体重差异无统计学意义。④药物观察期间未发生低血糖及消化道反应等。结论　那格列奈有明确的降低空腹血糖、餐后2h血糖及HbA1c的作用,副反应发生率低,是2型糖尿病患者一个安全有效的口服降糖药物。

Clinical experience for testifying the efficacy and safety of Nateglinide in treating type 2 diabetes

Objective To testify the efficacy and safety of a new oral hypoglycemic agent——Nateglinide in treating type 2 diabetic patients. Methods Forty-six patients with type 2 diabetes mellitus were divided into Nateglinide medication group and control group(Repaglinide group)and the subjects were administered with medicines for 12 weeks. Fasting finger point blood glucose,2 h postprandial blood glucose, fasting plasma glucose,2 h postprandial blood plasma glucose and HbA1c were measured. Results ①The results showed that Nateglinide reduced the mean fasting and 2 h postprandial blood glucose and HbA1c levels by 1.63 mmol/L, 4.43 mmol/L, 1.71% respectively.②There were no significantly difference in fasting and 2 h postprandial blood glucose between two groups after treatment.③Blood cholesterol ,body weight and blood pressure did not significantly change after treatment.④There were no hypoglycemia and gastrointestinal symptoms during medical treatment. Conclusion This result provides an efficacy in metabolic control and a safety profile of nateglinide in the treatment of type 2 diabetes.