The effects of Danzhi Jiangtang capsule on clinical indices and vascular endothelial function in patients with impaired glucose tolerance of Qi–Yin deficiency type

To observe the effect of Danzhi Jiangtang capsule (DJC) on the clinical indexes and vascular endothelial function indexes in patients with impaired glucose tolerance (IGT). A total of 106 patients were enrolled and randomly assigned to the treatment group and control group following a four-week washout period. The patients in the control group received a general lifestyle intervention, while those in the treatment group received DJC (2.0 g 3× a day) in conjunction with the intervention given to the control group patients. The physiological and biochemical levels, vascular endothelial function indices, and traditional Chinese medicine (TCM) syndrome ratings of the patients in the two groups were compared after 12 weeks of therapy. In the control group, the diastolic blood pressure (DBP) was significantly improved compared with those before treatment (83.31 ± 6.47 vs. 79.21 ± 6.17, <i>p</i> &lt; .01) (CI: 1.45, 6.73; Cohen’s <i>d</i>: 10.51), as was the case with the nitric oxide (NO) levels and TCM syndrome points (35.71 ± 4.58 vs. 43.96 ± 5.17, 9.57 ± 2.63 vs. 5.38 ± 1.79, <i>p</i> &lt; .001) (CI: –10.28, –6.24; 3.12, 5.18; Cohen’s <i>d</i>: 0.90). In the treatment group, the levels of fasting blood glucose, endothelin and vascular endothelial growth factor were significantly improved compared with control group (4.92 ± 0.21 vs. 5.59 ± 0.31, 59.37 ± 13.25 vs. 72.13 ± 12.37, 19.25 ± 2.80 vs. 26.76 ± 1.88, <i>p</i> &lt; .001) (CI: 0.55, 0.78; 7.40, 18.13; 6.52, 8.50; Cohen’s <i>d</i>: 4.94, 0.41, 1.32), as was the case with 2-h post-load plasma glucose and total cholesterol (TC) (8.33 ± 0.62 vs. 8.89 ± 1.55, 4.61 ± 1.05 vs. 5.22 ± 1.12, <i>p</i> &lt; .05) (CI: 0.07, 1.07; 0.15, 1.06; Cohen’s <i>d</i>: 0.40, 0.51). Treatment with DJC could significantly improve the physiological and biochemical indicators, vascular endothelial function, and TCM syndrome points of IGT patients, indicating that DJC could be a potential drug to treat patients with IGT of Qi–Yin deficiency type.

本研究旨在观察丹栀降糖胶囊（Danzhi Jiangtang capsule, DJC）对糖耐量减低（impaired glucose tolerance, IGT）患者的临床指标及血管内皮功能指标的影响。本研究共纳入106例患者，经过4周洗脱期后，将其随机分为治疗组与对照组。对照组患者仅接受常规生活方式干预，治疗组患者则在对照组干预基础上，加服丹栀降糖胶囊（每日3次，每次2.0g）。治疗12周后，比较两组患者的生理生化指标、血管内皮功能指标及中医证候（traditional Chinese medicine, TCM）积分。对照组患者的舒张压（diastolic blood pressure, DBP）较治疗前显著改善（83.31±6.47 vs. 79.21±6.17，p<0.01）（置信区间CI：1.45, 6.73；科恩d值Cohen’s d：10.51）；一氧化氮（nitric oxide, NO）水平及中医证候积分亦得到显著改善（35.71±4.58 vs. 43.96±5.17，9.57±2.63 vs. 5.38±1.79，p<0.001）（CI：–10.28, –6.24；3.12, 5.18；Cohen’s d：0.90）。与对照组相比，治疗组患者的空腹血糖、内皮素及血管内皮生长因子水平均显著改善（4.92±0.21 vs. 5.59±0.31，59.37±13.25 vs. 72.13±12.37，19.25±2.80 vs. 26.76±1.88，p<0.001）（CI：0.55, 0.78；7.40, 18.13；6.52, 8.50；Cohen’s d：4.94、0.41、1.32）；餐后2小时血浆葡萄糖及总胆固醇（total cholesterol, TC）水平亦得到显著改善（8.33±0.62 vs. 8.89±1.55，4.61±1.05 vs. 5.22±1.12，p<0.05）（CI：0.07, 1.07；0.15, 1.06；Cohen’s d：0.40、0.51）。丹栀降糖胶囊干预可显著改善糖耐量减低患者的生理生化指标、血管内皮功能及中医证候积分，提示该药可作为气阴两虚型糖耐量减低患者的潜在治疗药物。