含缓释淀粉的整蛋白型肠内营养剂对脏器功能、血胰岛素/血糖曲线下面积及血糖的影响(120例随机、对照、多中心临床研究)  

The Role of Slow Release Starch Containing Enteral Nutrition on Viscera Organ Functions,Glucose/Insulin Responses and Blood Glucose Levels in Type2Diabetic Patients (Randomized,Controlled,Multi-center Clinical Trial with120Cases)

作　　者：王姮[1] 蒋朱明[1] 袁申元[2] 李玉秀[1] 朱良湘[2] 于康[1] 付汉箐[2] 赵维纲[1] 冯凯[2] 刘秋英[1] 

机构地区：[1]中国医学科学院中国协和医科大学北京协和医院,北京100730 [2]北京首都医科大学北京同仁医院

出　　处：《中国临床营养杂志》2002年第2期75-78,共4页Chinese Journal of Clinical Nutrition

摘　　要：目的观察含缓释淀粉的整蛋白型肠内营养对2型糖尿病患者血胰岛素、血糖曲线下面积及血糖的影响。标准配方的肠内营养剂为对照药。方法符合研究计划要求的2型糖尿病患者120例,按随机表进入研究组及对照组。均住入医院或疗养院观察7天,观察期间患者不得进食任何食品,可饮白水。两组患者服用两种不同的肠内营养剂(FresubinDiabetes或Fresubinneutral),研究开始前和服用不同的肠内营养剂后第7天进行各项指标的监测。其中20例患者志愿参加血糖和胰岛素曲线下面积的测定以观察服用两种不同营养剂对血糖和胰岛素的影响水平。结果(1)安全性:两组肠内营养剂对血常规和肝肾功能均无不良影响。血糖曲线下面积研究:用药后与用药前血糖曲线下面积的差值:研究组:(-10913±7528)min·mg/dl,对照组:(1140±8094)min·mg/dl,两组对比差异有显著性(P=0.003),说明研究用药对血糖的影响明显小于对照药。(2)用药前后两组患者的血胰岛素曲线下面积的差值:研究组:(-1958±1773)min·μU/L,对照组:(-336±1654)min·μU/L,两组对比有差异但不显著(P=0.053)。(3)血糖的变化:餐后2小时血糖上升值(餐后2小时血糖-空腹血糖)研究开始前:研究组:(42.22±51.82)mg/dl,对照组:(45.1±47.79)mg/dl。表明两组患者用药前有可比性(P=0.75)。?Objective To evaluate the impact of slow-release starch containing enteral nutrition on blood sugar&insulin responses in type2diabetic patients.Method One hundred and twenty patients who met the requirements of the protocol joined this randomized,controlled multi-center clinical trail.The protocol was approved by Ethic Committer and,written consents were obtained from all patients.According to the time sequence of administra tion,patients were randomized into study group (receiving slow release starch containing enteral nutrition Fresubin Diabetes,Fresenius Kabi,Germany)or control group(receiving standard enteral nutrition Fresubin Neutral,Fresenius Kabi,Germany).Patients stayed in well controlled guest houses or hospital during the6-day period,no other food was allowed except drinking water.All patients had blood glucose and viscera organ functions tested for base line and after7days enteral nutrition,20patients of which volunteered to be examined by'Area under the curve(AUC)'for comparing the impact of different preparation on the glucose response&insulin response.Statistic analysis was done by software StatView(SAS institute,series no.STV04171,USA),ANOVA,Wellcoxon or Chi -square test were used when appropriate.Data espressed as mean±SD.Significant level was at P<0.05.Results All patients completed the whole study course without obvious adverse event.Principle viscera organ functions were not damaged.The changes of blood glucose were not significantly different between groups.AUC of glucose and AUC of insulin changes were showed as follows:after7days different enteral nutrition administration,the study group blood glucose response(expressed as AUC)was significantly lower (-10913±7528)min·mg /d compared with the control(-1140±8094)min·mg /dl(P=0.003).AUC of insulin was also lower in study group (-1958±1773)min·μU/Lcompared with the control group(336±1654)min·μU/L,but not significant (P=0.053).Conclusion Slow release starch containing enteral nutrition was well tolerated and,had significant l

关 键 词：缓释淀粉 整蛋白型 肠内营养 脏器功能 血胰岛素 血糖 影响 血糖曲线下面积 

分 类 号：R459.3[医药卫生—治疗学] R587.1[医药卫生—临床医学]