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,保持在试验过程中的稳态,减少误差,是科学评价传统医药治疗早期糖尿病肾病疗效的关键。
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, HbAlc and UAER had significant difference, P 〈 0.05 ; the positive rate of conventional urine protein and hypertension history had no significant difference, P 〉 0.05. Compared the positive rate of routine urineprotein in early diabetic nephropathy group of different UAER, there was significant difference, P 〈 0.05. There was a significant correlation between UAER and HbAlc in early diabetic nephropathy. Conclusion： 1. 24h UAER can be used as a sensitive index in the diagnosis and treatment of early diabetic nephropathy. 2. HbAlc and UAER are the main indicators to evaluate the curative efficacy of early diabetic ne- phropathy. 3. Diabetes duration, blood pressure, body weight and HbAlc are influence factors of kidney injury in diabetic nephropathy. In the clinical trials for traditional medical treatment of early diabetic nephropathy, we should stricdy control the risk factors caused by interfer- ence, keep steady state during experimental process and reduce the error, which is the key to scientific evaluation of traditional medicine cur- ative effect in the treatment of early diabetic nephropathy.
出处
《中药药理与临床》
CAS
CSCD
北大核心
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)
