Calero Rojas Miguel, Jurado Roger Aurora, Gutiérrez Grúa Marta, de la Peña Carretero Lourdes, Romero Sotomayor Victoria, López Braos Javier, Izquierdo Carrasco Federico, Herrero Tabanera Luis, Moreno Aguilar Carmen
Obstetrics and Gynaecology Unit, Hospital Infanta Margarita, Cabra, Spain.
Immunlogy and Allergy Unit, Hospital Universitario Reina Sofía-IMIBIC, Córdoba, Spain.
Adv Lab Med. 2021 Feb 17;2(1):87-107. doi: 10.1515/almed-2020-0072. eCollection 2021 Mar.
This work aimed to assess the diagnostic validity of two approaches for the screening of gestational diabetes mellitus (GDM) with less discomfort for pregnant women.
A prospective diagnostic validation study was conducted with 2007 pregnant women. According to risk factors for GDM, women were classified into high-risk and low-risk groups. The current diagnostic procedure, based on oral glucose overload, was followed; simultaneously HbA was tested and an algorithm combining both biomarkers was applied.
In the low-risk group, the Glucose challenge test (GCT) showed a higher area under the curve (AUC 0.953; 95% CI 0.915-0.992) than the HbA test (0.688; 95% CI 0.541-0.834). The best GCT cut-off, 153.5 mg/dL (8.52 mmol/L), showed higher diagnostic validity than that for HbA, 28 mmol/mol (4.75%), and that the algorithm using both tests. In the high-risk group, the GCT showed better diagnostic performance than the HbA and the algorithm; the optimal GCT cut-offs were higher than those recommended in current protocols. 13th week: GCT AUC 0.882 (95% CI 0.843-0.921), HbA AUC 0.624 (95% CI 0.562-0.686), GCT cut-off 140.5 mg/dL (7.8 mmol/L), HbA cut-off 33 mmol/mol (5.15%). 24th week: GCT AUC 0.944 (95% CI 0.925-0.962), HbA AUC 0.642 (95% CI 0.575-0.709), GCT cut-off, 145.5 mg/dL (8.08 mmol/L), HbA cut-off 29 mmol/mol (4.85%).
The GDM diagnostic approach using as the first step the GCT with higher cut-offs showed the best diagnostic validity. Applying these thresholds, 55.6 and 13.7% of 100 g. Oral glucose overloads would have been avoided in low-risk and high-risk pregnant women.
本研究旨在评估两种妊娠期糖尿病（GDM）筛查方法的诊断有效性，同时减少孕妇的不适。
对2007名孕妇进行了一项前瞻性诊断验证研究。根据GDM的危险因素，将孕妇分为高危组和低危组。遵循基于口服葡萄糖负荷试验的现行诊断程序；同时检测糖化血红蛋白（HbA），并应用结合两种生物标志物的算法。
在低危组中，葡萄糖耐量试验（GCT）的曲线下面积（AUC 0.953；95%可信区间0.915 - 0.992）高于HbA检测（0.688；95%可信区间0.541 - 0.834）。最佳GCT切点为153.5mg/dL（8.52mmol/L），其诊断有效性高于HbA的切点28mmol/mol（4.75%）以及使用两种检测方法的算法。在高危组中，GCT的诊断性能优于HbA和算法；最佳GCT切点高于现行方案推荐值。第13周：GCT AUC 0.882（95%可信区间0.843 - 0.921），HbA AUC 0.624（95%可信区间0.562 - 0.686），GCT切点140.5mg/dL（7.8mmol/L），HbA切点33mmol/mol（5.15%）。第24周：GCT AUC 0.944（95%可信区间0.925 - 0.962），HbA AUC 0.642（95%可信区间0.575 - 0.709），GCT切点145.5mg/dL（8.08mmol/L），HbA切点29mmol/mol（4.85%）。
以较高切点的GCT作为第一步的GDM诊断方法显示出最佳诊断有效性。应用这些阈值，低危和高危孕妇中分别可避免55.6%和13.7%的100g口服葡萄糖负荷试验。
