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

作　　者：仝小林[1] 倪青[1] 连凤梅[2] 胡镜清[2] 虞芳华[3] 欧阳雪琴[4] 姜喆[5] 吴深涛[6] 江红[7] 高天舒[8] 姚晨[9] 赵敏[10] 张勇[10] 

机构地区：[1]中国中医科学院广安门医院内分泌科,北京100053 [2]中国中医科学院广安门医院药物临床试验机构办公室,北京100053 [3]上海中医药大学附属曙光医院,上海200021 [4]吉林省中西医结合医院,长春132001 [5]长春中医药大学附属医院,长春130041 [6]天津中医药大学第一附属医院,天津300193 [7]辽宁中医药大学附属第二医院,沈阳110034 [8]辽宁中医药大学附属医院,沈阳110032 [9]北京大学第一医院,北京100034 [10]天津天士力制药股份有限公司,天津300410

出　　处：《中国临床药理学杂志》2009年第2期104-108,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：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.

关 键 词：糖敏灵丸 2型糖尿病 血糖 

分 类 号：R587.1[医药卫生—内分泌] R977.15[医药卫生—内科学]