降糖消脂胶囊治疗2型糖尿病患者的临床研究  

Clinical Study of Jiangtang Xiaozhi Capsule in Treating Type 2 Diabetes Mellitus Patients

作　　者：陈筑红[1] 夏城东[1] 魏子孝[1] 黄佳娜[1] 尚晓泓[1] 

机构地区：[1]中国中医科学院西苑医院内分泌科,北京100091

出　　处：《中国中西医结合杂志》2012年第7期910-913,共4页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：首都医学发展基金项目(No.03Ⅲ10);中国中医科学院西苑医院苗圃课题(No.2008-08-08)

摘　　要：目的评价降糖消脂胶囊治疗2型糖尿病(T2DM)气阴两虚、痰瘀互阻证的疗效及安全性。方法采用随机分组、平行对照、前瞻性研究方法,将73例T2DM气阴两虚、痰瘀互阻证患者随机分为降糖消脂胶囊治疗组(试验组,37例)和吡格列酮治疗组(对照组,36例),疗程8周,观测体重、身高、体重指数(BMI),腰围、臀围、腰臀比及中医症状评分;检测空腹血浆血糖(FBG)及餐后2小时血糖(PBG),糖化血红蛋白(HbA1c);血浆总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、血浆胰岛素(FINS)、计算胰岛素抵抗指数(HOMA-IR)。并进行肝、肾功能,不良事件等安全性指标观察。结果治疗8周后,两组治疗后HbA1c分别较治疗前下降(-0.59±1.99)%和(-0.27±2.73)%;PBG分别较治疗前下降(-1.71±2.52)mmol/L和(-0.72±4.17)mmol/L,差异均有统计学意义(P<0.05,P<0.01);但两组比较,差异无统计学意义(P>0.05)。试验组患者体重、BMI、TG明显降低(P<0.05);两组中医症状疗效及中医症状积分均显著减少,差异亦有统计学意义(P<0.01),且试验组优于对照组(P<0.05)。观察过程中均未发生严重不良事件,两药不良事件发生率比较,差异无统计学意义。结论降糖消脂胶囊降糖疗效与阳性对照药吡格列酮相似,两药均能改善临床症状,无严重不良反应。Objective To evaluate the efficacy and safety of Jiangtang Xiaozhi Capsule （JTXZC） in treating type 2 diabetes mellitus （ 1-2 DM） patients of qi-yin deficiency and inter-obstruction between phlegm and stasis. Methods Adopting prospective, randomized, controlled trial design, 73 T2DM patients of qi-yin defi- ciency and inter-obstruction between phlegm and stasis syndrome, were randomly assigned to two groups, the pioglitazone tablet group （36 cases） and the JTXZC group （37 cases）. The therapeutic course for all was 8 weeks. The body weight, height, body mass index （BMI）, waistline （WC）, hipline, waist-to-hip ratio （WHR）, and scoring for Chinese medicine （CM） symptoms assessment were observed. The fasting blood glucose （FBG）, 2-h postprandial blood glucose （~ PBG）, glycated hemoglobin （HbAlc）, plasma total choles- terol （TC）, triglyceride （TG）, high-density lipoprotein cholesterol （HDL-C）, low-density lipoprotein cholesterol （LDL-C）, plasma insulin （FINS） were detected. The HOMA-IR was also calculated. The safety indices such as liver and renal functions, adverse reactions were also observed. Results The levels of HbAlc were lowered after treatment in the two groups after 8 weeks of treatment, showing statistical difference when compared with before treatment （ -0.59% _＋1.99% and -0.27% _＋2.73%, P〈0. 05）. The PBG level also decreased with statistical difference （ - 1.71 ＋2.52 mmol/L and -0.72 ~4.17 retool/L, P〈0. 05）, but there was no statisti- cal difference between the two groups, The body weight, BMI, TG obviously decreased （P〈0.05）. The CM symptoms efficacy and CM symptom scoring were significantly reduced in the two groups （ P 〈 0.01 ）. Be- sides, better effects were shown in the JTXZC group （ P 〈 O. 05）. No severe adverse event occurred in either group during the therapeutic course. There was no statistical difference in the incidence of adverse events （ P 〉 0.05）. Conclusions JTXZC showed similar therape

关 键 词：降糖消脂胶囊 血糖 2型糖尿病 

分 类 号：R259[医药卫生—中西医结合]