糖化血红蛋白用于诊断2型糖尿病及糖尿病前期的临床研究

目的:评估糖化血红蛋白(HbAlc)对2型糖尿病(T2DM)及糖尿病前期的诊断价值.方法:为明确糖尿病(DM)诊断而就诊及DM高危人群筛查者共457例,其中男297例,女160例,平均年龄(61.4±13.1)岁,均行口服葡萄糖耐量试验(OGTT),并测定HbAlc.按照1999年WHO糖尿病的诊断标准将受试者分为糖耐量正常(NGT)组81例、空腹血糖受损(IFG)组7例、糖耐量异常(IGT)组76例、IFG+IGT组13例、DM组280例.采用受试者工作曲线(ROC曲线)来判断其最佳切点.结果:HbAlc诊断DM的切点为6.45％,敏感性为0.794,特异性为0.825,曲线下面积为0.871(95％CI 0.839～0.903).HbAlc诊断糖尿病前期的切点为5.85％,敏感性为0.583,特异性为0.531,曲线下面积为0.587(95％ CI 0.504～0.671).依据HbAlc≥6.45％来诊断糖尿病时,漏诊率为21.1％；应用空腹血糖(FPG)≥7.0 mmol/L或HbAlc≥6.45％时,敏感性为0.871,特异性为0.623,漏诊率为12.9％.结论:在筛查T2DM时,同时检测HbAlc和FPG可降低漏诊率.

Clinical Research of Glycated Hemoglobin for Diagnosis of Diabetes Mellitus and Pre-Diabetes

Objective:To assess the diagnostic value of glycated hemoglobin (HbA1c) for diabetes mellitus (DM) and pre-diabetes. Methods: Four hundred and fifty-seven subjects (297 male, 160 female,average age 61.4 years±13.1 years), for screening diabetes, underwent an oral glucose tolerance test (OGTT). The value of HbA1c was examined as well. Based on 1999 WHO criteria,subjects were divided into normal glucose tolerance group (NGT, n=81), impaired fasting glucose group (IFG, n=7), impaired glucose tolerance group (IGT, n=76), IFG+IGT group (n=13) and DM group (n=280). The receiver operat ing characteristic curve (ROC curve) was used to judge the optimal cut-point. Results: The optimal cut-point of HbA1c for DM was 6.45% that was associated with the sensitivity and specificity of 0.794 and 0.825 respectively. The area under the curve was 0.871 (95% CI 0.839-0.903). The cut-point of HbAlc for pre-diabetes was 5.85%,which was associated with the sensitivity and specificity of 0.583 and 0.531 respectively. The area under the curve was 0.587(95% CI 0.504-0.671). When HbA1c≥6.45% was used to diagnose diabetes, the misdiagnosis rate was 21.1%. When FPG≥7.0 mmol/L or HbA1c≥ 6.45% was used to diagnose diabetes, the sensitivity was 0.871, specificity was 0.623 and the rate of misdiagnosis was 12.9%. Conclusion: The detection of FPG and HbA1c may reduce the misdiagnosis rate of T2DM.