降糖消脂胶囊治疗2型糖尿病患者的临床研究

作者	单位
陈筑红	中国中医科学院西苑医院内分泌科
夏城东	中国中医科学院西苑医院内分泌科
魏子孝	中国中医科学院西苑医院内分泌科
黄佳娜	中国中医科学院西苑医院内分泌科
尚晓泓	中国中医科学院西苑医院内分泌科

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中文摘要:

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。

英文摘要:

Objective To evaluate the efficacy and safety of Jiangtang Xiaozhi Capsule(JTXZC) in treating type 2 diabetes mellitus(T2DM) 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 deficiency 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(HbA1c),plasma total cholesterol(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 HbA1c 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 mmol/L,P<0.05),but there was no statistical 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).Besides,better effects were shown in the JTXZC group(P<0.05).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 therapeutic effects to pioglitazone.They both could effectively improve clinical symptoms with no severe adverse reaction.

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