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目的:考察使用那格列奈治疗的初诊2型糖尿病患者血药浓度与临床疗效的相关性。方法:73例初诊2型糖尿病患者在饮食控制及体育锻炼基础上,三餐前口服那格列奈,疗程2个月,监测治疗期间出现的不良反应,观察治疗前后空腹血糖(FBG)、空腹C肽(F-CP)、餐后2h血糖(2h-PG)、餐后2h C肽(P-CP)、糖化血红蛋白(Hb Alc)的变化,并于治疗最后1天静脉取血,采用LC-MS法测定血药浓度。结果:治疗后患者FBG、2h-PG、Hb Alc显著降低、P-CP显著升高,差异有统计学意义(P<0.05),F-CP虽较治疗前略有升高,但差异无统计学意义(P>0.05);那格列奈血药浓度与治疗前后Hb Alc差值、P-CP差值均呈正相关(P<0.05)。结论:初诊2型糖尿病患者使用那格列奈可获得良好的疗效及安全性,那格列奈血药浓度可作为临床胰岛功能改善和降糖药效学评价的新方法。
OBJECTIVE: To investigate the correlation between plasma concentration and clinical efficacy of newly diagnosed type 2 diabetic patients treated with nateglinide. Methods: 73 patients with newly diagnosed type 2 diabetes were given nateglinide orally before meals on the basis of diet control and physical activity. The course of treatment was 2 months. The adverse reactions during the treatment were monitored. The levels of fasting blood glucose (FBG), fasting C-peptide (F-CP), postprandial 2h blood glucose (2h-PG), postprandial 2h peptide C (P-CP) and HbAlc were measured. -MS method for determination of plasma concentration. Results: After treatment, FBG, 2h-PG and Hb Alc were significantly decreased and P-CP was significantly increased in the patients with significant difference (P <0.05). The F-CP was slightly higher than before treatment, but the difference was not statistically significant (P> 0.05). The plasma nateglinide concentration was positively correlated with the differences of HbAc and P-CP before and after treatment (P <0.05). Conclusion: Nateglinide can provide good curative effect and safety in newly diagnosed type 2 diabetic patients. Nateglinide plasma concentration can be used as a new method to evaluate the clinical features of pancreatic islet function and hypoglycemic efficacy.