液态酶法测定糖化白蛋白在2型糖尿病合并低血清白蛋白患者中的临床价值

发布时间：2018-10-09 07:29

【摘要】：目的:糖尿病(Diabetes mellitus,DM)是一种慢性全身代谢性疾病,其发病率逐年升高。目前临床最常用的血糖监测方法为时间点血糖和糖化血红蛋白(Glycated hemoglobin A1c,Hb A1c)。这两种检验虽然能满足大部分糖尿病患者诊断和血糖监测的需要,但在很多情况下无法准确反映患者血糖变化,如爆发性1型糖尿病和缺铁性贫血等[1]。糖化白蛋白(Glycated albumin,GA)是一种重要的糖尿病血糖水平的指示剂,它比糖化血红蛋白对血糖变化更为敏感,能反映近2~3周的血糖控制水平[2]。本课题通过液态酶法测定GA,探讨其与空腹血糖(Fasting plasma glucose,FPG)及Hb A1c的相关性及其优势,并探讨其在2型糖尿病合并低血清白蛋白患者中的临床价值。方法:选择2013年7月至2014年5月于我院内分泌科及肾内科住院的2型糖尿病患者共164例纳入本研究,其中男89例,女75例,平均年龄(52.66±9.51)岁;单纯2型糖尿病患者132例,2型糖尿病合并血清白蛋白降低者(血清白蛋白38g/L)32例。所有患者均符合1999年WHO糖尿病诊断和分型标准,均为河北地区汉族人,彼此间无亲缘关系。入选者均排除贫血、妊娠、肝功能障碍(ALT或AST超过参考范围上限)、肾病综合征、甲状腺疾病、糖尿病急性并发症及正在接受糖皮质激素治疗的患者。选取同期在我院健康体检血糖正常者共145例纳入本研究,其中男80例,女65例,平均年龄(52.51±8.24)岁,均为河北地区汉族人,彼此间无亲缘关系,除外糖尿病、高血压、心脑肾等疾病史。记录所有入选者性别、年龄、身高、体重,并计算体重指数(Body mass index,BMI)。所有受试者均签署知情同意书,符合医学伦理学规定。根据是否患有2型糖尿病将所有入选者分为糖尿病组(DM组,n=164)及正常对照组(NC组,n=145),DM组患者分别于入院第2天及治疗2周后测定GA、FPG及Hb A1c,研究各项指标的变化并进行相关性分析。根据血清白蛋白是否降低(ALB38g/L)将入选者分为两组:(1)低血清白蛋白组(LA组,n=32),其中男18例,女14例,平均年龄(52.56±9.63)岁;(2)血清白蛋白组正常(NA组,n=277),其中男151例,女126例,平均年龄(52.59±8.86)岁。分别测定各组GA、FPG、Hb A1c及血清白蛋白(Albumin,ALB)水平,研究GA与各项指标的相关性。统计学分析:应用SPSS 22.0统计软件对结果进行统计学分析,所有计量资料用均值±标准差(x±s)表示,并检验正态性、方差齐性;组内差异比较用配对t检验,组间差异比较用两独立样本均数t检验;GA与Hb A1c、FPG及ALB之间的相关性分析用直线相关与回归分析及协方差分析,以P0.05为差异有统计学意义。结果:1 DM组与NC组间各项指标:(1)两组间性R%、年龄、身高、体重无统计学差异(均P0.05),与NC组相比,DM组BMI显著升高(P0.05),两组有可比性;(2)与NC组相比,DM组治疗前GA、FPG及Hb A1c水平均明显升高,差异有统计学意义(均P0.01);(3)在DM组,经2周治疗后患者GA、FPG及Hb A1c较治疗前均明显下降,差异有统计学意义(均P0.01);(4)在NC组,GA与FPG(r=0.159,P0.05)、Hb A1c(r=0.870,P0.01)呈正相关;在DM组,治疗前GA与FPG(r=0.694,P0.01)、Hb A1c(r=0.918,P0.01)呈正相关;经2周治疗后,在DM组GA与FPG(r=0.387,P0.01)、Hb A1c(r=0.789,P0.01)仍呈正相关;(5)DM组患者治疗前后GA的变化值(ΔGA=治疗前GA-治疗后GA)与治疗前GA的回归分析方程为Y=0.45X-7.58,治疗前后Hb A1c的变化值(ΔHb A1c=治疗前Hb A1c-治疗后Hb A1c)与治疗前Hb A1c的回归分析方程为Y=0.29X-1.77,治疗前后FPG的变化值(ΔFPG=治疗前FPG-治疗后FPG)与治疗前FPG的回归分析方程为Y=0.91X-5.77,可见GA的斜率小于FPG(0.45vs0.91),大于Hb A1c(0.45vs0.29)。2 LA组与NA组间各项指标:(1)LA组与NA组相比,性R%、年龄、身高、体重、BMI均无统计学差异(均P0.05),两组有可比性;(2)与NA组相比,LA组GA、FPG及Hb A1c水平明显升高,差异有统计学意义(均P0.05),ALB明显降低,差异有统计学意义(P0.01);(3)在NA组,GA与FPG(r=0.809,P0.01)、Hb A1c(r=0.961,P0.01)呈正相关;(4)在LA组,GA与FPG(r=0.722,P0.01)、Hb A1c(r=0.938,P0.01)呈正相关;(5)NA组受试者GA与Hb A1c的回归分析方程为Y=2.93X-0.16,LA组受试者GA与Hb A1c的回归分析方程为Y=2.64X+2.18,经交互效应检测,两者斜率无统计学差异(F=3.209,P0.05),可以进行协方差分析;(6)用协方差分析方法分析LA组和NA组中Hb A1c与ALB对GA的影响,结果协变量Hb A1c的结果为(F=3452.150,P0.01),提示Hb A1c对GA水平有显著的影响,ALB的结果为(F=0.241,P0.05),提示ALB水平对GA水平没有显著的影响。结论:1液态酶法测定GA与FPG及Hb A1c均有良好的相关性,能良好地反映受试者的血糖情况,可作为2型糖尿病患者的血糖监测指标。2液态酶法测定GA可反映短期内(2-3周)血糖控制情况,其对血糖变化的灵敏性优于Hb A1c,稳定性优于时间点血糖。3液态酶法测定GA,不受血清白蛋白水平的影响,可以准确反映受试者短期血糖变化。
[Abstract]:Objective: Diabetes mellitus (DM) is a chronic systemic metabolic disease whose incidence increases year by year. At present, the most commonly used glucose monitoring methods are time-point blood glucose and glycosylated hemoglobin (Hb). Although these two tests can meet the needs of diagnosis and blood glucose monitoring in most diabetics, it is not possible to accurately reflect patient's blood glucose changes in many cases, such as explosive type 1 diabetes and iron deficiency anemia[1]. Glycated albumin (GA) is an important indicator of diabetic blood sugar level, which is more sensitive to blood sugar change than glycosylated hemoglobin, and can reflect the blood glucose control level of nearly 2 to 3 weeks. In this study, GA was determined by liquid enzyme method, and its correlation with fasting plasma glucose (FPG) and Hb concentration was studied and its clinical value in patients with type 2 diabetes mellitus complicated with low serum albumin was discussed. Methods: 164 patients with type 2 diabetes hospitalized in our hospital from July 2013 to May 2014 were included in this study, including 89 males and 75 females with an average age (52. 66, 9. 51). 132 patients with type 2 diabetes mellitus and 32 patients with type 2 diabetes mellitus complicated with serum albumin (38g/ L). All patients met the 1999 WHO criteria for diagnosis and classification of diabetes mellitus, all of which have no genetic relationship with each other in the Hebei region. Patients enrolled exclude anemia, pregnancy, liver dysfunction (ALT or AST exceeding the upper limit of the reference range), nephrotic syndrome, thyroid disease, acute complications of diabetes, and patients undergoing treatment with corticosteroids. During the same period, 145 patients were enrolled in this study, including 80 males and 65 females, with an average age (52. 51, 8. 24), all of which belong to the northern region of the Hebei region, unrelated to each other, with the exception of diabetes mellitus, hypertension, and renal disease. All incoming sex, age, height, body weight were recorded and the Body mass index (BMI) was calculated. All subjects signed informed consent to comply with the medical ethics requirements. All patients with type 2 diabetes were divided into diabetes group (DM group, n = 164) and normal control group (NC group, n = 145). Serum albumin (ALB38g/ L) was divided into two groups: (1) low serum albumin group (LA group, n = 32), among them 18 males and 14 females, mean age (52. 56, 9. 63); (2) Normal serum albumin (NA group, n = 277), among which 151 males and 126 females were females. Mean age (52. 59/ 8. 86). The levels of GA, FPG, Hb concentration and serum albumin (Albumin) in each group were measured, and the correlation between GA and various indexes was studied. Statistical analysis: Statistical analysis of the results was carried out by SPSS 10.0 statistical software. All the measured data were represented by mean square deviation (x/ s), and the positive state and homogeneity were tested. The paired t test was used for the difference in the group, and the difference between the groups was tested with two independent samples. Linear correlation and regression analysis and covariance analysis were used to analyze the correlation between GA and Hb, and the difference between FPG and Hb was statistically significant. Results: (1) There was no statistical difference between group 1 DM and NC group (P <0.05). Compared with NC group, the BMI of DM group increased significantly (P0.05). The levels of FPG and Hb were significantly higher in DM group (P <0.01); (3) In DM group, GA, FPG and Hb were significantly lower in DM group than before treatment (P <0.01); (4) in NC group, GA and FPG (r = 0.159, P0.05), Hb (r = 0.870). In DM group, GA was positively correlated with FPG (r = 0.494, P0.01), Hb (r = 0.9918, P0.01). After 2 weeks of treatment, GA was positively correlated with FPG (r = 0.387, P0.01), Hb (r = 0.789,P0.01). (5) The regression analysis equation of GA before and after treatment of patients with DM group was Y = 0.945X-7.58, and the regression analysis equation of Hb concentration before and after treatment was Y = 0.9X-1.77. The change value of FPG before and after treatment (FPG = before treatment, FPG before treatment) and the regression analysis equation of FPG before treatment were Y = 0.95X-5.77, and the slope of the visible GA was smaller than FPG (0.04572.0. 91). The indexes between group 2 LA and NA group: (1) LA group compared with NA group, sex R%, age, height, body weight, There was no statistical difference in BMI (P0.05), and the two groups were comparable; (2) Compared with NA group, the levels of GA, FPG and Hb of LA group were significantly higher, the difference was significant (P0.05), the difference was significantly lower (P <0.01), and (3) in NA group, GA and FPG (r = 0.809, P0.01). In group LA, GA and FPG (r = 0.722, P0.01), Hb (r = 0.9938, P0.01) were positively correlated; (5) The regression analysis equation of GA and Hb in NA group was Y = 2.93X-0.16.The regression analysis equation of GA and Hb in group LA was Y = 2.64X + 2.18, and was detected by interaction effect. There was no statistical difference between the two slopes (F = 3. 209, P0.05), and covariance analysis could be carried out; (6) The effect of Hb concentration in LA group and NA group on GA was analyzed by covariance analysis method. Results The results of covariate Hb relaxation were (F = 3452. 150, P 0.01), suggesting that Hb concentration had a significant effect on GA level. The results were (F = 0. 241, P0.05), suggesting that there was no significant effect on GA level. Conclusion: 1 The liquid enzymatic method has a good correlation with FPG and Hb, which can reflect the blood glucose level of the subjects, and can be used as the blood sugar monitoring index of type 2 diabetes patients. The liquid enzymatic method can reflect the control of blood glucose in short term (2-3 weeks). Its sensitivity to blood sugar change is better than Hb, stability is better than that of time point blood sugar. 3 liquid enzyme method to determine GA, not affected by serum albumin level, can accurately reflect the subject's short-term blood sugar change.
【学位授予单位】：河北医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R587.1

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