Chen Zhu-Hong, Xia Cheng-Dong, Wei Zi-Xiao
Department of Endocrinology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing.
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 Jul;32(7):910-3.
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.
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.
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).
JTXZC showed similar therapeutic effects to pioglitazone. They both could effectively im- prove clinical symptoms with no severe adverse reaction.
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。
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。
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）。
JTXZC与吡格列酮疗效相似，均可有效改善临床症状，且无严重不良反应。
