关于妊娠糖尿病筛查的随机试验

来源：NEJM医学前沿

关于妊娠糖尿病筛查的随机试验

Randomized Trial of Gestational Diabetes Screening

2021年3月11日

朗读者：Dr. Stephen Morrissey, NEJM执行主编

妊娠糖尿病是妊娠最常见的并发症之一，母亲和婴儿均有发生不良结局的风险。目前建议在妊娠24~28周进行普遍筛查，但关于两种筛查方法哪种更佳尚未达成共识。短视频中总结了新的研究发现。

关于妊娠糖尿病筛查的实效性随机临床试验

A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening

摘 要

背景

妊娠糖尿病多发，且与孕产妇和围生期不良结局的风险增加相关。虽然专家建议对妊娠糖尿病进行普遍筛查，但目前有两种推荐的筛查方法，我们尚未就使用哪种方法达成共识。

Background

Gestational diabetes mellitus is common and is associated with an increased risk of adverse maternal and perinatal outcomes. Although experts recommend universal screening for gestational diabetes, consensus is lacking about which of two recommended screening approaches should be used.

方法

我们开展了一项实效性随机试验，本试验纳入了在两个医疗系统接受检查治疗的所有孕妇，并比较了一步筛查法（即空腹口服75 g葡萄糖负荷之后测定血糖水平的葡萄糖耐量试验）和两步筛查法（即非空腹口服50 g葡萄糖负荷之后测定血糖水平的葡萄糖负荷试验，以及之后在结果呈阳性的情况下空腹口服100 g葡萄糖负荷的口服葡萄糖耐量试验）。妊娠糖尿病治疗指南也采用上述两种筛查方法。主要结局包括妊娠糖尿病诊断、大于胎龄儿、围生期复合结局（死产、新生儿死亡、肩难产、骨折或与产伤相关的手臂或手部神经麻痹）、妊娠高血压或先兆子痫以及首次剖宫产。

Methods

We performed a pragmatic, randomized trial comparing one-step screening (i.e., a glucose-tolerance test in which the blood glucose level was obtained after the oral administration of a 75-g glucose load in the fasting state) with two-step screening (a glucose challenge test in which the blood glucose level was obtained after the oral administration of a 50-g glucose load in the nonfasting state, followed, if positive, by an oral glucose-tolerance test with a 100-g glucose load in the fasting state) in all pregnant women who received care in two health systems. Guidelines for the treatment of gestational diabetes were consistent with the two screening approaches. The primary outcomes were a diagnosis of gestational diabetes, large-for-gestational-age infants, a perinatal composite outcome (stillbirth, neonatal death, shoulder dystocia, bone fracture, or any arm or hand nerve palsy related to birth injury), gestational hypertension or preeclampsia, and primary cesarean p.

结果

共计23,792名孕妇接受了随机分组；在本试验期间多次妊娠的女性可被分配不止一种筛查方法。一步筛查组66%的孕妇和两步筛查组92%的孕妇依从了分配的筛查。一步筛查组16.5%的孕妇和两步筛查组8.5%的孕妇被诊断为妊娠糖尿病（未校正的相对危险度，1.94；97.5%置信区间[CI]，1.79~2.11）。在意向治疗分析中，其他主要结局的发生率如下：大于胎龄儿，8.9%和9.2%（相对危险度，0.95；97.5% CI，0.87~1.05）；围生期复合结局，3.1%和3.0%（相对危险度，1.04；97.5% CI，0.88~1.23）；妊娠高血压或先兆子痫，13.6%和13.5%（相对危险度，1.00；97.5% CI，0.93~1.08）；首次剖宫产，24.0%和24.6%（相对危险度，0.98；97.5% CI，0.93~1.02）。在考虑到对不同筛查方法的依从性差异，因而采用逆概率加权的意向治疗分析中，结果基本不变。

Result

A total of 23,792 women underwent randomization; women with more than one pregnancy during the trial could have been assigned to more than one type of screening. A total of 66% of the women in the one-step group and 92% of those in the two-step group adhered to the assigned screening. Gestational diabetes was diagnosed in 16.5% of the women assigned to the one-step approach and in 8.5% of those assigned to the two-step approach (unadjusted relative risk, 1.94; 97.5% confidence interval [CI], 1.79 to 2.11). In intention-to-treat analyses, the respective incidences of the other primary outcomes were as follows: large-for-gestational-age infants, 8.9% and 9.2% (relative risk, 0.95; 97.5% CI, 0.87 to 1.05); perinatal composite outcome, 3.1% and 3.0% (relative risk, 1.04; 97.5% CI, 0.88 to 1.23); gestational hypertension or preeclampsia, 13.6% and 13.5% (relative risk, 1.00; 97.5% CI, 0.93 to 1.08); and primary cesarean p, 24.0% and 24.6% (relative risk, 0.98; 97.5% CI, 0.93 to 1.02). The results were materially unchanged in intention-to-treat analyses with inverse probability weighting to account for differential adherence to the screening approaches.

结论

虽然一步筛查法的妊娠糖尿病诊断率高于两步筛查法，但在与围生期和孕产妇并发症相关的主要结局风险方面，两组无显著差异。（由尤尼斯·肯尼迪·施莱佛国立儿童健康与人类发展研究所[Eunice Kennedy Shriver National Institute of Child Health and Human Development]资助；ScreenR2GDM在ClinicalTrials.gov注册号为NCT02266758。）

Conclusions

Despite more diagnoses of gestational diabetes with the one-step approach than with the two-step approach, there were no significant between-group differences in the risks of the primary outcomes relating to perinatal and maternal complications. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ScreenR2GDM ClinicalTrials.gov number, NCT02266758.)

Teresa A. Hillier, Kathryn L. Pedula, Keith K. Ogasawara, et al.  A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening. DOI: 10.1056/NEJMoa2026028

来源：NEJM-yixueqianyan NEJM医学前沿