糖敏灵丸治疗2型糖尿病随机双盲平行对照多中心临床试验

Multi-center randomized controlled and double blind trial of Tang-min-ling pills in the treatment of type 2 diabetes mellitus

目的评价糖敏灵丸(降血糖中药方剂)治疗2型糖尿病的有效性和安全性。方法用随机双盲平行对照多中心临床试验方法,选择中医辨证为肝胃郁热证、超重的初发2型糖尿病患者210例,随机分为3组:糖敏灵丸12、6 g组与安慰剂组,均每日给药3次,疗程12周。结果治疗后,糖敏灵丸12 g组糖化血红蛋白(HbA1c)平均降低了1.14%,糖敏灵丸6 g组HbA1c平均降低了1.18%,安慰剂组HbA1c降低了0.33%,3组比较,差异有统计学意义(P<0.001);空腹血糖、餐后2 h血糖、中医证候及中医症状、BM I、腰围的变化,3组比较差异均有统计学意义(P<0.05)。药物不良反应发生率3组比较差异无统计学意义(P>0.05)。结论糖敏灵丸治疗2型糖尿病有效,安全性较好;其Ⅲ期推荐剂量为每次6 g,每日3次。

Objective To evaluate the efficacy of Tang-min-ling pills in the treatment of type 2 diabetes mellitus. Methods Two hundred ten of overweight patients inflicted with primary diabetes mellitus who had stagnated heat of liver and stomach syndrome were recruited, which were divided into 3 groups in a randomized, doubled blind, dose-paralleled-control, multi-centre clinical design. The patients were randomly taken with high-dosage （ 12 g Tang-min-ling pills every time） , low-dosage （6 g Tang-min-ling pills every time） ,placebo by 3 times every day for 12 weeks. Results After treatment, hemoglobin Alc（HbAlc） of the 12 g Tang-min-ling pills group was reduced 1.14% meanly, HbAlc of the 6 g Tang-min-ling pills group was reduced 1.18% meanly and HbAlc of the placebo group was reduced 0. 33% meanly. The differences in three groups were significant （ P 〈 0. 001 ）. Fasting plasma glucose （ FPG）, postprandial 2 hours plasma glucose （2hPG） , syndrome 、 symptoms 、 body mass index （ BMI ）, waist circumference （ WC ） of these groups were changed, the difference of these changes in three groups was significant （P 〈 0. 05 ）. The rate of adverse reaction in three groups was insignificant （P 〉 0. 05 ）. Conclusion The Tang-min-ling pills has effect in treating type 2 diabetes mellitus patients,and the medicine is safety. The dosage of Tang-min-ling pills in m phase of clinical trial is 6 g every time and 3 times every day after analyzed all dates.