尿集聚蛋白羧基片段在早期2型糖尿病肾病进展监测中的价值  

Value of urinary C-terminal agrin fragment in monitoring the progression of early kidney injury in type 2 diabetic patients

作　　者：黄珍 林秦燕 孙涛 徐燕娉 岳小芳 贾君麟 张杭杭 李翔 张巩 易维京 郑超[3,5] 陶志华[1] Huang Zhen;Lin Qinyan;un Tao;Xu Yanping;Yue Xiaofang;Jia Junlin;Zhang Hanghang;Li Xiang;Zhang Gong;Yi Weijing;Zheng Chao;Tao Zhihua(Department of Laboratory Medicine,the Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310000,China;Blood Transfusion Department,the Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310000,China;Department of Endocrinology,the Second Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,China;Zhongyuan Huiji Biotechnology Co.,Ltd.,Chongqing 400084,China;Second Affiliated Hospital of Zhejiang University School of Medicine)

机构地区：[1]浙江大学医学院附属第二医院检验科,杭州310000 [2]浙江大学医学院附属第二医院输血科,杭州310000 [3]温州医科大学附属第二医院内分泌科,温州325000 [4]中元汇吉生物技术股份有限公司,重庆400084 [5]浙江大学医学院附属第二医院

出　　处：《中华检验医学杂志》2022年第7期717-723,共7页Chinese Journal of Laboratory Medicine

摘　　要：目的尿集聚蛋白羧基片段(uCAF)酶促化学发光免疫检测方法性能评估并探讨其在早期2型糖尿病肾病进展监测中的价值。方法收集2018年10月至2020年3月就诊于温州医科大学附属第二医院的2型糖尿病患者251例进行回顾性分析,将2021年2月浙江大学医学院附属第二医院的健康体检者156例作为对照。记录患者临床基础信息、糖化血红蛋白和血清肌酐值等,收集尿液标本进行尿肌酐、尿α1微球蛋白(uα_(1)M)、尿免疫球蛋白G(uIgG)、尿白蛋白、尿N-乙酰-β-D氨基葡萄糖苷酶(uNAG)和uCAF检测。评估uCAF酶促化学发光免疫测定方法最佳反应条件、线性范围、检测限和批内批间变异系数。根据估算的肾小球滤过率(eGFR)将251例患者分为G1~G5期,分别为116、22、28、55和30例;再将166例早期糖尿病肾病(G1~G3期)患者按尿白蛋白/肌酐比值(UACR)分为A1亚组(79例)、A2亚组(48例)和A3亚组(39例),根据uα_(1)M水平分为uα_(1)M亚组1(83例)、uα_(1)M亚组2(42例)、uα_(1)M亚组3(41例),根据uIgG水平分为uIgG亚组1(83例)、uIgG亚组2(42例)、uIgG亚组3(41例)。采用Spearman法分析uCAF水平与eGFR、UACR、uα_(1)M和uIgG水平的相关性。结果(1)uCAF酶促化学发光免疫测定方法的线性范围为3.97~2000.00 ng/ml,检出限为2.28 ng/ml,批内变异系数为1.15%、1.57%,批间变异系数为1.63%、5.78%,生物参考区间<95.35μg/g Cr;(2)G1~G3期uCAF水平和阳性率(UACR≥30 mg/g)随着eGFR下降而升高,uCAF水平与eGFR值呈负相关(r=-0.543,P<0.0001),阳性率由24.14%(28/116)升高至85.71%(24/28)。G4~G5期uCAF水平和阳性率随着eGFR下降而下降,uCAF水平与eGFR值呈正相关(r=0.495,P<0.001),阳性率由30.91%(17/55)降至23.33%(7/30);(3)早期糖尿病肾病患者随着UACR的升高,uCAF水平和阳性率也逐渐升高,uCAF水平与UACR值呈正相关(r=0.602,P<0.001),A1亚组中uCAF阳性率达21.52%(17/79);(4)早期糖尿病肾病患者uCAF水平与uα_(1)M、uIgG水平均呈�Objective This study aimed to explore the feasibility and clinical value of monitoring the progression of early kidney injury in type 2 diabetic patients by assessment of the urinary C-terminal agrin fragment(uCAF)with enzymatic chemiluminescence immunoassay.Methods A total of 251 patients with type 2 diabetes,who attended the Second Affiliated Hospital of Wenzhou Medical University from October 2018 to March 2020,were included in this retrospective analysis.One hundred and fifty-six participants undergoing health check-up at the Second Affiliated Hospital of Zhejiang University School of Medicine in February 2021 served as controls.Basic clinical information,glycosylated hemoglobin type A1c and serum creatinine values were recorded,and urine specimens were collected for urinary creatinine,urinaryα1 microglobulin(uα_(1)M),urinary immunoglobulin G(uIgG),urinary albumin,urinary N-Acetyl-B-D-glycosaminidase(uNAG)and uCAF measurements.Based on the estimated glomerular filtration rate(eGFR),251 patients were classified into G1~G5 stage groups with 116,22,28,55 and 30 patients in each group.One hundred and sixty-six patients with early diabetic kidney disease(stage G1-G3)were divided into subgroups A1(79),A2(48)and A3(39)according to the urinary albumin/creatinine ratio(UACR),the uα_(1)M levels were divided into uα_(1)M subgroup 1(83 cases),uα_(1)M subgroup 2(42 cases),and uα_(1)M subgroup 3(41 cases),and uIgG subgroup 1(83 cases),uIgG subgroup 2(42 cases),and uIgG subgroup 3(41 cases)according to uIgG levels.The Spearman method was used to analyze the correlation between uCAF levels and eGFR,UACR,uα_(1)M and uIgG levels.Results(1)The linear range of the uCAF detected by enzymatic chemiluminescence immunoassay was 3.97-2000.00 ng/ml,with a detection limit of 2.28 ng/ml,intra-batch coefficients of variation of 1.15% and 1.57%,inter-batch coefficients of variation of 1.63% and 5.78%,and a biological reference interval of<95.35μg/g Cr.(2)The uCAF level and positive rate(UACR≥30 mg/g)increased with the decrease o

关 键 词：糖尿病 2型 糖尿病肾病 化学发光免疫分析 集聚蛋白羧基片段 

分 类 号：R587.2[医药卫生—内分泌] R692.9[医药卫生—内科学]