盐酸二甲双胍缓释片的降糖效能随机对照研究

Efficacy of Metformin Hydrochloride Sustained-release Tablet in Type 2 Diabetic Patients-a Randomized Controlled Multicenter Clinical Trial

目的探讨盐酸二甲双胍缓释片治疗2型糖尿病患者的临床效果和安全性。方法以二甲双胍普通片为对照,对76例患者在2家医院进行了6周的随机对照试验研究。分别在基线、疗后2周和疗后6周,随访观测患者体重、血糖、血脂等糖尿病相关指标。结果在整个疗程中,控制了基线水平的混杂后,组间差异除LDL-C试验组比对照组的下降水平要高于对照组外(P<0.05),其余指标组间差异均无统计学意义(P>0.05)。同时组内重复测量表明,HbA1c和LDL-C在整个疗程中均有明显的下降趋势(P<0.05),其余指标变化不明显。两组不良反应发生率无显著性差异(P>0.05)。结论盐酸二甲双胍缓释片在疗效和安全性上和普通片相当,但由于剂型优势,其依从性要高于普通片,因此具有较强的临床推广价值。

Objective To evaluate the efficacy of metformin hydrochloride sustained-release tablet on blood glucose control in type 2 diabetic patients. Methods A randomized controlled multicenter clinical trial was conducted. 76 chinese type 2 diabetic patients were enrolled in 2 clinical centers. The patients were divided randomly into Experimental group （metformin hydrochloride sustained-release tablet 1500mg, q. d, n= 38） or control group （metforrnin hydrochloride tablets 500mg, t. i. d, n=38）. At baseline, week 2 and 6, related laboratory and physical examina- tions were performed. Results Expect LDL-C, there were no significant difference between the two groups either in efficacy indexes or the incidence of adverse reactions. But, HbAlc level and LDL-C were both decreased significantly in the two groups. Safety parameters did not show any notable differences between the two groups in weight changes, laboratory values, or hypoglycemie event frequency. Conclusions The efficacy and safety of metformin hydrochloride sustained-release tablet in lowering hyperglycemia is comparable to metformin hydrochloride tablet.