黄连荷叶方联合二甲双胍治疗肥胖型2型糖尿病湿热中阻证的临床研究

Clinical effect of Huanglian Heye formula combined with metformin in the treatment of obese type 2 diabetes with damp-heat retention

目的 探讨黄连荷叶方联合二甲双胍治疗肥胖型2型糖尿病(T2DM)湿热中阻证的疗效及对血管内皮功能、动脉弹性功能的影响。方法 选取肥胖型T2DM湿热中阻证患者120例,应用随机数字表法分为对照组(60例)和试验组(60例)。对照组予以盐酸二甲双胍片0.5 g/次,每日3次;试验组在对照组药物治疗的基础上加用黄连荷叶方口服,每日2次。两组均连续治疗12周。对比2组临床疗效,并比较2组治疗前后中医证候积分、空腹血糖(FPG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)、胰岛素抵抗指数(HOMA-IR)、体质量指数(BMI)、腰臀比(WHR)等代谢指标,以及反应性充血指数(RHI)、臀踝脉搏波传导速度(PWV)、血清脂蛋白相关磷脂酶A2(Lp-PLA2)等血管病变指标的变化。结果 2组临床疗效差异有统计学意义(P<0.05),且试验组总有效率(95.00%)高于对照组(80.00%)。与治疗前相比,治疗后2组的中医证候积分、FPG、2 h PG、HbA1c、HOMA-IR、BMI、WHR、PWV、Lp-PLA2均降低(P<0.05,P<0.01),RHI水平升高(P<0.05,P<0.01)。2组治疗后比较,试验组的中医证候积分、2 h PG、HbA1c、HOMA-IR、BMI、WHR、Lp-PLA2水平降低(P<0.01),RHI水平升高(P<0.05),FPG、PWV水平降低(P<0.05)。结论 黄连荷叶方联合二甲双胍治疗能够有效控制肥胖型T2DM湿热中阻证患者的血糖,改善胰岛素抵抗,减轻体质量,还可改善血管内皮功能和动脉弹性功能,疗效较好。

Objective To explore the efficacy of Huanglian Heye formula combined with metformin in the treatment of obese type 2 diabetes(T2 DM) with damp-heat retention and its influence on vascular endothelial function and arterial elasticity.Methods A total of 120 obese T2 DM patients with damp-heat retention were included. The patients were divided into a control group(60 cases) and an experimental group(60 cases) by the random number table method;the control group was given metformin(0.5 g/time, three times daily), and the experimental group was given Huanglian Heye formula(two times daily) combined with metformin. Both groups were treated for 12 weeks. The clinical effect was compared between the two groups, and the metabolic indexes, including the traditional Chinese medicine(TCM) syndrome score, fasting plasma glucose(FPG), 2 h postprandial plasma glucose(2 h PG), glycosylated hemoglobin(HbA1 c), insulin resistance index(HOMA-IR), body mass index(BMI), waist-to-hip ratio(WHR), vascular endothelial function [reactive hyperemia index(RHI), hip-ankle pulse wave velocity(PWV), and lipoprotein-associated phospholipase A2(Lp-PLA2)] were compared between the two groups before and after treatment.Results The difference in clinical effect between the two groups was statistically significant(P<0.05), and the total effective rate of the experimental group was 95.00%, which was higher than the 80.00% of the control group. Compared with the patients before treatment, the TCM syndrome score, FPG, 2 h PG, HbA1 c, HOMA-IR, BMI, WHR, PWV and Lp-PLA2 in the two groups after treatment were significantly lower(P<0.05, P<0.01), while the RHI level was higher(P<0.05, P<0.01). When comparing the two groups after treatment, the TCM syndrome score, 2 h PG, HbA1 c, HOMA-IR, BMI, WHR and Lp-PLA2 level in the experimental group were significantly decreased(P<0.01), the RHI level was increased(P<0.05), and the FPG and PWV were decreased(P<0.05).Conclusion Huanglian Heye formula combined with metformin can effectively improve blood glucose and insulin resistance in obese T2 DM patients with damp-heat retention, reduce body mass, and improve vascular endothelial function and arterial elasticity function, with good curative effect.