糖克软胶囊治疗2型糖尿病气阴两虚证的临床研究

The clinical studies of Tangke Capsules on treating type 2 diabetes(Qi and Yin Deficiency)

目的:观察糖克软胶囊治疗2型糖尿病气阴两虚证的临床疗效。方法:采取随机、双盲、安慰剂设计,试验组给予糖克软胶囊(0.2g/粒),1粒/次,1日2次(早晚各一次);对照组给予安慰剂软胶囊(0.2g/粒),1粒/次,1日2次(早晚各一次),均于餐前口服。疗程为84天,观察糖化血红蛋白、血糖、中医证候、胰岛素敏感性指标及血脂变化情况。结果:糖克软胶囊具有降低糖化血红蛋白的作用,与对照组比较差异有统计学意义;同时对血糖(FPG、2hPG)和糖负荷后曲线下面积(AUCG)、中医证候、胰岛素敏感性指标(ISI)、血脂(TG、TC、HDL-C、LDL-C)具有一定作用,但与对照组比较,差异均无统计学意义。结论:糖克软胶囊具有降低2型糖尿病-气阴两虚证患者糖化血红蛋白的作用,值得进一步研究。

To evaluate Tangke intervention blood glucose control in type 2 diabetes （ Qi Deficiency） safety and effectiveness. Meth- ods： The 40 cases of type 2 diabetes （ TCM Syndrome is a Qi and Yin deficiency） were randomly divided into 2 groups by a randomized, double-blind, placebo design. There were 20 cases in the experimental group by taking oral of Tangke capsules （0.2g / tablets, 1 tablet/ times,2 times/day） ,and the other 20 cases in control group by taking oral of placebo （0.2g/tablets, 1 tablet/times,2 times/day）. The courses of the treatment were 84 days. Results： The test screening a total of 45 subjects were randomized to dO cases, 36 cases included in the FAS analysis, and experimental group of 18 cases, 18 cases in the control group; included in the PPs analysis of 34 cases, the experi- mental group of 17 cases in the control group 17 cases; 37 cases completed the study, completed the trim of three cases, the experimental group off two cases of the control group, shedding one cases. Excluding the three cases, which test group 1 patients in the control group 2 ca- ses. With the advance of treatment time, Primary efficacy endpoint of glycosylated hemoglobin test group and control group to improve the de- gree of FAS analysis difference was statistically significant （P 〈 0.05 ）, secondary outcome measures glucose （FPG, 2hPG） and glucose load after the area under the curve （AUCG）, TCM syndrome, insulin sensitivity index （ISI）, lipids （TG,TC, HDL-C, LDL-C） comparison showed no significant difference （P 〉 0.05）, by FAS and the PP analysis. Conclusion： Though the effections of Tangke on glucose, lip- ids, insulin sensitivity index of TCM syndrome intervention is not obvious, but the index of HbA1C improved, but the curative effects to need further clinical study.