清化颗粒对具备“热”证素特征2型糖尿病患者糖代谢、胰岛功能和氧化应激水平的疗效观察

Clinical Observation on Effect of Qinghua Granules on Glycometabolism,Pancreatic Islet Function and Oxidative Stress in Type-2 Diabetics with Heat Syndrome

目的:观察清化颗粒对具备"热"证素特征2型糖尿病患者糖代谢、胰岛功能和氧化应激水平的影响。方法:在上海中医药大学附属曙光医院内分泌科门诊招募符合具备中医"热"证素特点(《证素辩证学》)2型糖尿病患者共60例,平均年龄(57.9±6.9)岁,随机分为治疗组和对照组,在保留原降糖方案基础上,治疗组加用清化颗粒,对照组加用安慰剂,每日1包,冲服,疗程为12周。服药前后分别于空腹、标准馒头餐后120 min留取血清。主要评价指标:空腹血糖(FPG)、餐后血糖(PPG)、糖化血红蛋白(HbA1c);次要评价指标:稳态模式评估指数(HOMA2%B、HOMA2%S、HOMA2%IR),超氧化物歧化酶(SOD)、谷胱甘肽过氧化物酶、丙二醛(MDA),总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白。组间疗效比较采用方差分析。结果:治疗组HbA1c明显下降、HOMA2%B明显上升,对照组未见显著性变化,2组间存在差异(P=0.044,P=0.016)。治疗组SOD明显上升、MDA明显下降,对照组未见显著性变化,组间比较存在差异(P=0.011,P=0.049);血脂等其它评价指标未见改变。结论:清化颗粒能改善具备"热"证素特点2型糖尿病患者糖代谢、胰岛β细胞功能和氧化应激程度。

This study was aimed to evaluate effect of Qinghua Granules（QHG） on glycometabolism,pancreatic islet function and oxidative stress in type-2 diabetics with heat syndrome.A total of 60 cases of type-2 diabetics with heat syndrome（according to the Syndrome Element Syndrome Differentiation） were enrolled in the clinic of the Department of Endocrinology and Metabolism,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.The average age of enrolled cases was（57.9 ± 6.9） years.Enrolled cases were randomly divided into the treatment group and the control group.The original hypoglycemic plan was continued to use.In the treatment group,QHG was administrated.And in the control group,placebo was given.The administration dosage in both groups was one package per day.The treatment course was 12 weeks.The fasting and postprandial（120 min after standard meal） blood samples before and after medication were collected.The main evalua tion indexes were fasting plasma glucose（FPG）,postprandial plasma glucose（PPG） and hemoglobin A1c（HbA1c）.The secondary evaluation indexes were homeostasis model assessment（HOMA2-% B,HOMA2-% S,HOMA2%-IR）,superoxide dismutase（SOD）,glutathione peroxidase（GSH-PX）,maleic dialdehyde（MDA）,total cholesterol（TC）,triglyceride（TG）,high-density lipoprotein（HDL） and low-density lipoprotein（LDL）.The anal ysis of variance was used in the comparison of efficacy between two groups.The results showed that HbA1c in the treatment group was obviously reduced,and HOMA2-% B was obviously increased.There was no significant changes in the control group（P = 0.044,P = 0.016）.In the treatment group,SOD increased obviously,MDA reduced obviously.There was no significant change in the control group.There was difference b etween two groups（P = 0.011,P = 0.049）.There was no change on blood lipids or other evaluation indexes.It was concluded that QHG is effective in the improvement of glycometabolism,islet β-cell functions and oxidative stress in type-2 diabetics with heat syndrome.