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妊娠期糖尿病的即时检验点血糖检测的前瞻性评估。

A Prospective Evaluation of Point-of-Care Measurements of Maternal Glucose for the Diagnosis of Gestational Diabetes Mellitus.

机构信息

UCD Centre for Human Reproduction, Department of Obstetrics and Gynaecology, Coombe Women and Infants University Hospital, Dublin, Ireland.

Department of Biochemistry, Coombe Women and Infants University Hospital, Dublin, Ireland.

出版信息

Clin Chem. 2020 Feb 1;66(2):316-323. doi: 10.1093/clinchem/hvz005.

Abstract

BACKGROUND

Point-of-care (POC) measurement of glucose is currently recommended only for the monitoring of gestational diabetes mellitus (GDM). This prospective observational study evaluated the use of POC measurements of maternal glucose to diagnose GDM in women being screened selectively with a 1-step 75 g oral glucose tolerance test (OGTT).

METHODS

The strictest preanalytic and analytic international laboratory standards were applied to measure maternal plasma glucose at fasting and at 1 and 2 h post glucose load. The recent International Association of Diabetes and Pregnancy Study Groups diagnostic criteria were used. At the same time, maternal capillary glucose was measured. Because of differences in plasma and capillary glucose measurements, regression analysis of POC capillary glucose results vs laboratory plasma glucose results was conducted. The regression equations for plasma glucose were derived in a derivation cohort (n = 102). These equations were applied in the validation cohort (n = 100). Predicted and actual plasma glucose values were compared.

RESULTS

Of the 202 women screened, 36.6% were nulliparous, 56.4% were obese, and 81.2% were Irish-born. Two thirds had a single risk factor for GDM, and a third had multiple risk factors. Based on the plasma measurements, 53.5% had GDM. As a predictor of GDM, the diagnostic accuracy of POC measurement was 83.0% (95% confidence interval, 74.2-89.8).

CONCLUSIONS

In high-resource settings where measures to inhibit glycolysis are implemented, the use of POC measurements for the diagnosis of GDM is not justified based on this study. In low- and medium-resource settings, where measures to inhibit glycolysis are not achievable, regression analysis using POC measurements may be acceptable compared with plasma samples subject to glycolysis.

摘要

背景

目前仅推荐即时检测(POC)血糖测量用于监测妊娠糖尿病(GDM)。本前瞻性观察研究评估了 POC 测量孕妇血糖在选择性使用一步法 75g 口服葡萄糖耐量试验(OGTT)筛查时用于诊断 GDM 的作用。

方法

应用最严格的国际实验室分析前和分析标准测量空腹和葡萄糖负荷后 1 小时及 2 小时时的母体血浆葡萄糖。使用最近的国际糖尿病与妊娠研究组诊断标准。同时测量母体毛细血管葡萄糖。由于血浆和毛细血管葡萄糖测量存在差异,对 POC 毛细血管葡萄糖结果与实验室血浆葡萄糖结果进行回归分析。在推导队列(n=102)中得出血浆葡萄糖的回归方程。这些方程应用于验证队列(n=100)。比较预测的和实际的血浆葡萄糖值。

结果

在 202 名接受筛查的女性中,36.6%为初产妇,56.4%肥胖,81.2%为爱尔兰出生。60%有 GDM 的单一危险因素,30%有多个危险因素。根据血浆测量结果,53.5%患有 GDM。作为 GDM 的预测指标,POC 测量的诊断准确性为 83.0%(95%置信区间,74.2-89.8)。

结论

在实施抑制糖酵解措施的高资源环境中,根据本研究,使用 POC 测量来诊断 GDM 是不合理的。在低资源和中等资源环境中,由于无法实施抑制糖酵解的措施,与受糖酵解影响的血浆样本相比,使用 POC 测量进行回归分析可能是可以接受的。

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