天芪降糖胶囊预防2型糖尿病:一项在中国糖耐量减低患者中进行的随机、双盲、安慰剂对照研究

Tianqi Jiangtang capsule for prevention of type 2 diabetes mellitus: a randomized, double-blind, placebocontrolled study in Chinese individuals with impaired glucose tolerance

目的观察天芪降糖胶囊对预防糖耐量减低(ICT)患者向2型糖尿病(T2DM)发展的效果。方法 216例ICT患者,随机分为2组,分别口服天芪降糖胶囊(TQ组,110例)和对照组(Con组,106例),观察治疗后血糖变化及转化为正常血糖和T2DM的比例。结果天芪降糖胶囊治疗后服糖2h血糖(2hPG)值明显低于基线值(P=0.000),且2hPC下降幅度大于Con组(P<0.005);与Con组相比,天芪降糖胶囊使T2DM发生风险下降56%。结论天芪降糖胶囊可显著降低ICT患者向T2DM发展的风险。

Objective To assess whether Tianqi Jiangtang capsule could prevent the development of type 2 diabetes mellitus （T2DM） in high-risk Chinese individuals with impaired glucose tolerance （IGT）. Methods In the double-blind, 12-month prospective study, 216 IGT subjects from communities of Yichang city in Hubei province were included, IGT was defined by 1999 WHO. These subjects were randomly assigned to Tianqi Jiangtang capsule group （n=110） or placebo group（n= 106）. OGTT, weight, blood pressure, liver and kidney function, lipids were measured every three months during the follow-up. Treatment was not stopped until participants developed T2DM or euglycemia. Results In Tianqi Jiangtang capsule group, the 2-h postprandial glucose （2hPG） at the end of the study was lower than at baseline（P=0. 000）. The decrement of 2hPG in Tianqi Jiangtang capsule group was higher than in placebo group （P〈0. 005）. Fasting plasma glucose （FPG） had no significant reduction in both groups. Patients treated with Tianqi Jiangtang capsule had a lower risk of progression to T2DM than did on placebo group, so the risk of T2DM reduced by 56% after Tianqi Jiangtang capsule treatment of IGT. More people in the Tianqi Jiangtang capsule group achieved euglycemia than in the placebo group （61.80% vs 44. 3%）. Conclusion Tianqi Jiangtang capsule can reduce the development of T2DM in high-risk Chinese individuals with IGT. In the future, Tianqi Jiangtang capsule could be used on prevention of type 2 diabetes mellitus.