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].

作者信息

Chen Zhu-Hong, Xia Cheng-Dong, Wei Zi-Xiao

机构信息

Department of Endocrinology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing.

出版信息

Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 Jul;32(7):910-3.

PMID:23019945

Abstract

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 im- prove clinical symptoms with no severe adverse reaction.

摘要

目的

评价降糖消脂胶囊（JTXZC）治疗气阴两虚兼痰瘀互结型2型糖尿病（T2DM）患者的疗效及安全性。

方法

采用前瞻性、随机、对照试验设计，将73例气阴两虚兼痰瘀互结证的T2DM患者随机分为两组，即吡格列酮片组（36例）和JTXZC组（37例）。两组疗程均为8周。观察患者体重、身高、体重指数（BMI）、腰围（WC）、臀围、腰臀比（WHR）及中医症状评分。检测空腹血糖（FBG）、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），并计算胰岛素抵抗指数（HOMA-IR）。观察肝肾功能等安全指标及不良反应。

结果

治疗8周后两组HbA1c水平均较治疗前降低，差异有统计学意义（-0.59%±1.99%和-0.27%±2.73%，P<0.05）。PBG水平也降低，差异有统计学意义（-1.71±2.52 mmol/L和-0.72±4.17 mmol/L，P<0.05），但两组间差异无统计学意义。体重、BMI、TG明显降低（P<0.05）。两组中医症状疗效及中医症状评分均显著降低（P<0.01），且JTXZC组效果更佳（P<0.05）。治疗过程中两组均未发生严重不良事件，不良事件发生率差异无统计学意义（P>0.05）。