早期糖尿病肾病相关因素分析及其在传统医药临床试验设计中的应用  

Analysis of related factors of early diabetic nephropathy and its application in traditional medicine clinical trial design

作　　者：刘芝[1] 杜玉君[1] 孟帮柱[2] 韩志强[2] 巴图德力根[2] 

机构地区：[1]吉林大学第一医院肾病内科,长春130021 [2]内蒙古民族大学附属医院,通辽028007

出　　处：《中药药理与临床》2015年第1期224-228,共5页Pharmacology and Clinics of Chinese Materia Medica

基　　金：内蒙古自治区蒙医药标准化研究项目-蒙药复方制剂药效评价及标准化研究(2014-019)

摘　　要：目的:分析尿微量白蛋白排泄率、糖化血红蛋白、血糖、高血压、体重指数、病程与早期糖尿病肾病病变程度的关系,探讨在传统医药治疗早期糖尿病肾病临床试验方案设计中的应用,并提供参考依据。方法:根据1999年WHO糖尿病诊断标准,将6.0%≤Hb Alc≤8.0%,血压<140/90mm Hg的Ⅱ型糖尿病患者168例,按照尿微量白蛋白排泄率(UAER)水平的高低分为2组:糖尿病无肾病组(UAER<20ug/min)和早期糖尿病肾病组(20ug/min<UAER<200ug/min)。早期糖尿病肾病组根据Hb Alc水平分为6.0%<Hb Alc≤7.0%组和7.0%<Hb Alc≤8.0%组。于早晨空腹8小时后采静脉血,检测糖化血红蛋白(Hb Alc)、血肌酐(SCr)、空腹血糖(FPG),留晨尿检测尿常规,留24小时尿样检测尿微量白蛋白(m ALB)计算UAER,餐后2小时采静脉血测餐后血糖(PG)。对组间病程、高血压史、体重指数(BMI)、糖化血红蛋白(Hb Alc)、血糖、24h尿微量白蛋白排泄率(UAER)、尿常规、血肌酐(SCr)进行对比分析。探讨早期糖尿病肾病UAER与病程、Hb Alc、血糖、BMI的相关性。结果:糖尿病无肾病组与早期糖尿病肾病组间比较,Hb Alc、FPG、PG无显著性差异;病程、高血压史、体重指数(BMI)、UAER、常规尿蛋白阳性率有显著性差异。早期糖尿病肾病不同水平Hb Alc两组间比较,病程、Hb Alc、UAER有显著性差异;常规尿蛋白阳性率和高血压病史无显著性差异。早期糖尿病肾病不同UAER组间常规尿蛋白阳性率比较,有显著性差异。早期糖尿病肾病UAER与HbA lc有显著相关性。结论:(1)24h尿微量白蛋白排泄率可以作为早期糖尿病肾病诊疗的敏感指标。(2)糖化血红蛋白和尿微量白蛋白排泄率是早期糖尿病肾病疗效评估的主要指标。(3)糖尿病病程、血压、体重、糖化血红蛋白都是糖尿病肾病肾损伤的影响因素,在传统医药治疗早期糖尿病肾病临床试验中应严格控制危险因素带来的干扰,保持在试验�Objective： To analyze the relationship between urinary albumin excretion rate （UAER）, glycosylated hemoglobin （HbAlc）, blood glucose, hypertension, body mass index （BMI） and disease duration and the severity of early diabetic nephropathy, to discuss the application of traditional medicine in clinical trial design for treatment of early diabetic nephrc,pathy, and to provide a reference basis. Methods： With ref- erence to the diabetes diagnostic criteria of WHO in 1999, 168 patients with type Ⅱ diabetes that 6% ≤ HbAlc ≤ 8%, blood pressure 〈 140/90mmHg, according to UAER level were divided into 2 groups： diabetic group without nephropathy （ UAER 〈 20ug/min） and early dia- betic nephropathy group （20ug/min 〈 UAER 〈 200ug/min）. The early diabetic nephropathy group was also divided into 6.0% 〈 HbAlc≤ 7.0% group and 7.0% 〈 HbAlc≤ 8 . 0% group according to the level of HbAlc. The venous blood was collected in the morning after 8 hour of fasting to detect the level of HbAlc, serum creatinine （SCr） and fasting blood glucose （FlaG）. Simultaneously the morning urine was used to do urinary routine examinations, the 24h urine was used to test urine microalbumin （mALB） and calculate the UAER, and the venous blood 2h after meal was collected to measure postprandial glucose （PG）. The disease course, hypertension history, BMI, HbAlc, blood glu-cose, 24h UAER, urine routine and SCr between groups were comparatively analyzed to investigate the relationship between the UAER of ear- ly diabetic nephropathy and the disease course, HbAlc, blood glucose and BMI. Results： Compared the diabetes without nephropathy group with the early diabetic nephropathy group, the HbAlc, FPG and PG had no significant difference, P 〉 0.05 ; the disease course, hypertension history, BMI, UAER and the positive rate of routine urine protein had significant difference, P 〈0. 05. Compared between the two early dia- betic nephropathy groups of different HbAlc levels, the disease course, HbAl

关 键 词：糖化血红蛋白 尿微量白蛋白 早期糖尿病肾病 临床试验 

分 类 号：R285[医药卫生—中药学]