天芪降糖胶囊联合二甲双胍治疗2型糖尿病随机、双盲、平行对照、多中心临床研究

目的观察天芪降糖胶囊联合二甲双胍治疗2型糖尿病的有效性和安全性。方法将79例长期单服二甲双胍无效的糖尿病患者随机分为治疗组（40例）和对照组（39例），治疗组加服天芪降糖胶囊，对照组加服安慰剂。两组疗程均为12周，观察HbA1c、FPG、2hPG、血脂和胰岛素等指标的变化，并记录不良事件。结果治疗组服用天芪降糖胶囊后，HbA1c、TC、LDL-C的水平均有所下降，TC和LDL-C与对照组比较，差异有统计学意义（P〈0．05）；真胰岛素抵抗指数治疗组有所下降，对照组有所上升；未见严重不良事件发生。结论天芪降糖胶囊联合二甲双胍治疗2型糖尿病，可安全有效降低患者HbA1c水平，调节血脂，促进胰岛素分泌。

The combined Tian Qi Jiangtang capsule and metformin treatment in patients with type 2 diabetes mellitus:A randomized,parallel-group,muiticenter,double-blind and prospective study

Objective To observe the effectiveness and safety of the combined Tian Qi Jiangtang capsule （TQJT） and metformin treatment of patients with type 2 diabetes. Methods 79 diabetic patients poorly controlled by metformin were randomly divided into the treatment group （the addition of TQJT, n=40） and control group （the addition of placebo, n=39）. We observed and compared the variation of HbA1c, FPG, PBG, blood lipid and insulin, and recorded the adverse events during 12 weeks of treatment. Results TQJT group versus control group had statistically significant decrements in total cholesterol, low density lipoprotein （P〈0. 05） , and no severe adverse events happened. HOMA true IR increased in control and decreased in treatment group （P〉 0.05）. Conclusion Tian Qi Jiangtang capsule combined with metformin can safely and effectively reduce the glyeosylated hemoglobin and lipid levels in T2DM patients, promote insulin secretion, thus postpone the development of diabetic complications.