那格列奈治疗糖耐量低减的有效性和安全性观察

The Efficacy and Safety of Nateglinide in the Treatment of Impaired Glucose Tolerance

目的观察那格列奈治疗糖耐量低减（IGT）的有效性和安全性HTH。方法入选IGT患者40例，随机分为试验组（那格列奈组）和对照组（安慰剂组）各20例。试验者每餐前10min口服那格列奈（30～90mg）或安慰剂。采用随机、双盲、安慰剂对照的方法治疗12周。结果与基线值（0周）比较，12周试验组糖化血红蛋白（HbA1c）下降（0.67±0．22）％，空腹血糖（FPG）下降（0.56±0．26）mmol／L，餐后2h血糖（2hPG）下降（3．46±1．25）mmol／L（P〈0.05，P〈0.01）；对照组HbA1c升高（0.12±0．09）％，FPG下降（0.11±0．04）mmol／L，2hPG升高（0.23±0．21）mmol／L（P均〉0．05）。在12周治疗过程中，两组体重均无明显变化，除低血糖外未见其他不良反应，共有4例发生轻度低血糖，其中那格列奈组3例（15％），安慰剂组1例（5％），差异无统计学意义（P〉0．05）。结论那格列奈可有效降低1GT个体的餐后血糖，安全性和耐受性好。

Objective To investigate the efficacy and safety of Nateglinide in the treatment of subjects with impaired glucose tolerance （IGT）. Methods A total of 40 subjects with IGT were enrolled and divided randomly into two groups,the test group （neteglinide group, 20 cases） and the control group （placebo group, 20 cases） . The subjects received nateglinide （30-90 mg） or placebo before each main meal （10 min pre-meal）. The study was conducted using random, double-blind, parallel-controlled method for 12 weeks. Results Compared with the baseline value （0 week）, the HbA1c, fasting plasma glucose （FPG）, 2 h post-meal plasma glucose （2 hPG） in the test group decreased by （0.67±0.22）%, （0.52 ± 0.26）mmol/L, （3.46 ± 1.25）mmol/L respectively in the 12th week（P〈0.05,P〈0.01）, while the HbA1c, FPG, 2 hPG in the control group decreased （-0.12±0.09）%, （0.11 ±0.04）mmol/L, （-0.23±0.21）mmol/L respectively （P〉 0.05）. There were significant difference between the two groups in the comparison of the above indexes （P〈0.01）. During the treatment of 12 weeks, symptoms of hypoglycemia were the only adverse events. Confirmed hypoglycemia occurred in 3 subjects receiving nateglinide （60 mg, 1; 90 mg, 2） and in 1 subject receiving placebo. Conclusion Nateglinide was well tolerated, safe and effective in reducing postprandial hyperglycemia in subjects with IGT.