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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


Teresa A. Hillier ... 糖尿病 妇产科和儿科 • 2021.03.11
相关阅读
• 一步和两步筛查法:哪种是诊断妊娠糖尿病的最佳方法 • 妊娠糖尿病的后遗效应 • 妊娠期糖尿病——一个评估长期健康的窗口

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。

 

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。

 

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。

 

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)。





作者信息

Teresa A. Hillier, M.D., Kathryn L. Pedula, M.S., Keith K. Ogasawara, M.D., Kimberly K. Vesco, M.D., M.P.H., Caryn E.S. Oshiro, Ph.D., Suzanne L. Lubarsky, M.D., and Jan Van Marter, M.P.A., R.N.
From the Center for Health Research, Kaiser Permanente Northwest (T.A.H., K.L.P., K.K.V., J.V.M.), and the Division of Perinatology, Department of Obstetrics and Gynecology, Northwest Permanente, Kaiser Permanente (S.L.L.), Portland, Oregon; and the Center for Integrated Health Care Research (T.A.H., C.E.S.O.) and the Division of Perinatology, Department of Obstetrics and Gynecology (K.K.O.), Hawaii Permanente Medical Group (K.L.P., K.K.O.), Kaiser Permanente Hawaii, Honolulu. Address reprint requests to Dr. Hillier at the Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Ave., Portland, OR 97227, or at teresa.hillier@kpchr.org.

 

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