| 血清糖化清蛋白检测方法学评价、临床性能验证及其在糖尿病监测的应用研究 |
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| 引用本文： | 赵淑珍,郑锦仁,陈媛,茅夏铭.血清糖化清蛋白检测方法学评价、临床性能验证及其在糖尿病监测的应用研究[J].现代检验医学杂志,2020,0(5):77-81. |
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| 作者姓名： | 赵淑珍 郑锦仁 陈媛 茅夏铭 |
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| 作者单位： | 乌鲁木齐市中医医院检验科，乌鲁木齐 830000 |
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| 摘 要： | 目的 探讨血清糖化清蛋白（glycated albumin，GA）在糖尿病（diabetes mellius, DM）患者血糖监测和诊疗中
的应用价值，并对其进行性能评价。方法 选取乌鲁木齐市中医医院2018 年11 月~2019 年11 月收治的首次确诊156
例DM 患者作为观察组，同时选取150 例健康人员作为对照组，检测两组GA 和糖化血红蛋白（HbA1c）浓度并对酶法
测定GA 的精密度、准确度、线性范围进行性能评价; 使用配对资料χ2 检验，对GA 和HbA1c 进行一致性分析；使用t
检验分析两组GA 和HbA1c 差异；使用Pearson 相关分析评估GA 与HbA1c 之间关系；采用ROC 曲线评价GA 对DR
的诊断价值。结果 酶法测定GA 的精密度、准确度均可以接受，GA 在125~935μmol/L 范围内线性良好；观察组GA
（%）和HbA1c 的总一致性为90.38%，两种方法差异无统计学意义（P=1.060）；观察组GA（%）与HbA1c 结果明显
高于对照组，差异有统计学意义（t=17.31，9.59，均P ＜ 0.05）；GA（%）与HbA1c 呈正相关（P ＜ 0.01）；ROC 曲
线显示GA（%）诊断DM 的曲线下面积（AUC）为0.919，敏感度为91.02%，特异度为95.01%，差异均具有统计学意
义（P<0.05）。结论 酶法测定GA 的性能符合方法学评价指标要求，对GM 具有较高的诊断价值，可作为糖尿病筛查、
诊断、监测、预后的综合评价指标。
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| 关 键 词： | 糖尿病 糖化清蛋白 糖化血红蛋白 |
Application of Glycated Albumin in Diabetes Monitoring Indicators |
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| ZHAO Shu-zhen,ZHENG Jin-ren,CHEN Yuan,MAO Xia-ming.Application of Glycated Albumin in Diabetes Monitoring Indicators[J].Journal of Modern Laboratory Medicine,2020,0(5):77-81. |
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| Authors: | ZHAO Shu-zhen ZHENG Jin-ren CHEN Yuan MAO Xia-ming |
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| Affiliation: | Department of Clinical Laboratory,Urumqi Traditional Chinese Medicine Hospital,Urumqi 830000,China |
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| Abstract: | Objective To investigate the application value of serum glycated albumin (GA) in blood glucose monitoring and
diagnosis and treatment of diabetic patients, and evaluate its performance. Methods 156 patients with DM who were diagnosed
for the first time in Urumqi Hospital of traditional Chinese Medicine from November 2018 to November 2019 were selected as
the observation group, and 150 healthy people were selected as the control group. The concentrations of GA and glycosylated
hemoglobin (HbA1c) in the two groups were detected, and the precision, accuracy and linear range of GA determined by enzyme
method were evaluated.The difference of GA and HbA1c between two groupswere analyzed by χ2 test or t test.The relationship
between GA and HbA1c was evaluated by Pearson correlation analysis, and the diagnostic value of GA and HbA1c in DM was
evaluated by ROC curve. Results The coefficient of precision and accuracy of GA was accepted. GA had a good linearity in
the range of 125~935μmol/L.Chi-square test of paired data was performed,the difference between the two methods was not
statistically significant（P=1.060）. The result of GA（%）and HbA1c in observation group was significantly higher than that
in control group,the difference was statistically significant(t=17.31，9.59，all P <0.05).There was appositive correlation between
GA（%）and HbA1c.The area under ROC curve of GA in DM was 0.919,the difference was statistically significant(P <0.05).
Conclusion The performance of this method for measuring GA meets the requirements of methodological evaluation indicators.
It has high diafnostic value of DM,and it can be used as a comprehensive evaluation index of DM screening,diagnosis,monitoring
and prognosis. |
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