论文部分内容阅读
目的评价糖克软胶囊治疗2型糖尿病(气阴两虚证)的有效性及安全性。方法 40例2型糖尿病患者随机分为试验组(基础治疗+糖克软胶囊0.4 g/d,n=20)和对照组(基础治疗+安慰剂软胶囊0.4 g/d,n=20)治疗,疗程12周,观察治疗前后两组糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后2小时血糖(2h PG)和4项血脂指标变化,以及中医证候情况评价。结果与治疗前和对照组比较,试验组治疗后HbA1c、治疗后4、8和12周FPG以及治疗后12周2h PG均显著降低(P<0.01)。对照组HbA1c、FPG和2h PG治疗前后差异无统计学意义。次要疗效指标:两组中医证候有一定改善趋势,但治疗前后无显著变化;4项血脂指标两组治疗前后差异均无统计学意义。两组均未见严重不良反应及低血糖事件。结论糖克软胶囊治疗2型糖尿病患者有一定的降糖疗效,且安全性较好。
Objective To evaluate the efficacy and safety of Cork soft capsule in the treatment of type 2 diabetes (Qi-Yin Deficiency Syndrome). Methods Forty patients with type 2 diabetes were randomly divided into experimental group (0.4g / d, n = 20) and control group (0.4g / d, n = 20) . The course of treatment was 12 weeks. The changes of HbA1c, FPG, 2h PG and 4 lipid indexes before and after treatment were observed, and the TCM syndromes were evaluated. Results Compared with before treatment and control group, HbA1c, FPG at 4, 8 and 12 weeks after treatment and PG at 2 and 12 weeks after treatment in experimental group were significantly decreased (P <0.01). The control group HbA1c, FPG and 2h PG difference was not statistically significant. Secondary efficacy indicators: TCM syndromes in both groups have a certain trend of improvement, but no significant changes were found before and after treatment. There was no significant difference in the four lipid parameters between the two groups before and after treatment. No serious adverse reactions and hypoglycemic events were seen in either group. Conclusion Tang Ke soft capsules in patients with type 2 diabetes have some hypoglycemic effect, and the safety is better.