芪药消渴胶囊治疗T2DM的疗效及安全性评价

Evaluation on the Efficacy and Safety of Qiyao Xiaoke Capsules in the Treatment of T2DM

目的评价芪药消渴胶囊治疗2型糖尿病(T2DM)的疗效及安全性。方法124例T2DM患者随机分为两组各62例,对照组给予常规治疗,研究组给予常规治疗+芪药消渴胶囊治疗,比较两组的疗效、血糖、血脂、肝肾功能以及不良反应。结果研究组的治疗总有效率显著高于对照组(P<0.05)。治疗后,两组的空腹血糖(FBG)、餐后2h血糖(2hPBG)、总胆固醇(TC)、甘油三酯(TG)、血尿氮素(BUN)、尿肌酐(Cr)及尿清蛋白/肌酐(UAlb/Cr)均显著降低(P<0.05),且研究组的FBG、2hPBG、TC、TG、BUN、Cr和UAlb/Cr均显著低于对照组(P<0.05)。治疗期间,两组的不良反应发生率比较,差异无统计学意义(P>0.05)。结论芪药消渴胶囊可调节T2DM患者的糖脂代谢水平,改善患者胰岛素抵抗状态,安全有效。

Objective To evaluate the efficacy and safety of Qiyao Xiaoke capsules in the treatment of type 2 diabetes mellitus (T2DM). Methods 124 patients with T2DM were randomly divided into two groups, with 62 cases in each group. The control group was treated with routine therapy, and the study group was treated with routine therapy + Qiyao Xiaoke capsules. The efficacy, blood glucose, blood lipids, liver and kidney function, and adverse reactions were compared between the two groups. Results The total effective rate of treatment of study group was significantly higher than that of control group (P <0.05). After treatment, both groups had significantly decreased fasting blood glucose (FBG), 2-hour postprandial blood glucose (2hPBG), total cholesterol (TC), triglyceride (TG), blood urea nitrogen (BUN), urine creatinine (Cr) and urinary albumin/creatinine (UAlb/Cr), and the FBG, 2hPBG, TC, TG, BUN, Cr and UAlb/Cr of study group were significantly lower than those of control group (P<0.05). During treatment, no statistical difference was found between two groups in the incidence of adverse reactions (P>0.05). Conclusions Qiyao Xiaoke capsule is safe and effective, which can regulate the levels of glucose and lipid metabolism, and improve the insulin resistance status of patients with T2DM.