芪味糖平胶囊干预糖耐量减低的临床研究

Clinical study on the intervention effect of Qiweitangping capsule on impaired glucose tolerance

目的观察芪味糖平胶囊干预糖耐量减低(IGT)人群对糖尿病(DM)发病率的影响以及逆转为正常糖耐量(NGT)的作用。方法采用随机、双盲、安慰剂平行对照的试验设计方法,以口服75g葡萄糖耐量试验(OGTT)筛选,按1999年WHO诊断标准判定的100例患者进行2年前瞻性研究。初诊时患者按就诊顺序被随机分配至观察组与对照组,每组50例。入选的受试者均按正常生活规律工作和生活,不干预生活方式,只进行一般的IGT知识宣教。观察组口服芪味糖平胶囊3粒,每日2次。对照组口服安慰剂胶囊3粒,每日2次,2组疗程均24个月。观察2组干预后糖尿病发病率和IGT逆转率。结果观察组IGT发展为DM者为4.2%,对照组为25.5%;观察组IGT转NGT者为50.0%,对照组则为17.0%;2组比较差异有统计学意义(P<0.01)。同时,观察组对血糖、血脂、体质量指数和腰臀比也有改善作用(P<0.01),对照组除空腹血糖外其余指标均无显著变化(P>0.05),2组比较差异有统计学意义(P<0.05)。结论芪味糖平胶囊是预防IGT向2型DM发展的有效药物。

Objective To observe the intervention effects of Qiweitangping capsule on impaired glucose tolerance （IGT） and on the morbidity of diabetes mellitus （DM） ,and the effect of conversing IFT to normal glucose tolerance （NGT）. Methods A randomized, double-blinded, placebo-controlled, parallel-group trial was used in the study. 100 patients diagnosed according to the standard of WHO（1999） were screened by oral glucose tolerance test （OG- TF）, and their data were retrospectively analyzed. 100 patients were randomly divided into two groups, observation group （ n = 50） and control group（ n = 50）. The patients worked and lived according to routine life regulation, their life-way was not intervened and they were only informed by normal knowledge. The 50 patients in observation group were treated by Qiweitangping capsule 3 pills once, twice a day ; the other 50 patients in control group were given with placebo capsule 3 pills once, twice a day, with a treatment course of 24 months for both groups. The morbidity of DM and reverse rate of IGT were observed for both groups. Results The rate of IGT converting to DM was 4.2% in observation group and 25.5 % in control group, and the rate of IGT converting to NGT was 50.0% in observation group and 17.0% in control group, there were significant differences between two groups（ P 〈 0.01 ）. Meanwhile the blood glucose, blood lipid, body mass index and hip measurement in observation group were obviously improved （ P 〈 0.01 ）, but except for fasting glucose other parameters in control group were not changed significantly（ P 〉 0.05 ）. Conclusion Intervention treatment with Qiweitangping capsule is one of the effective measures to prevent the conversion of IGT to DM.