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孕11至13周时通过母体因素和生物标志物进行多中心子痫前期筛查:与英国国家卫生与临床优化研究所(NICE)指南及美国妇产科医师学会(ACOG)建议的比较

Multicenter screening for pre-eclampsia by maternal factors and biomarkers at 11-13 weeks' gestation: comparison with NICE guidelines and ACOG recommendations.

作者信息

O'Gorman N, Wright D, Poon L C, Rolnik D L, Syngelaki A, de Alvarado M, Carbone I F, Dutemeyer V, Fiolna M, Frick A, Karagiotis N, Mastrodima S, de Paco Matallana C, Papaioannou G, Pazos A, Plasencia W, Nicolaides K H

机构信息

Harris Birthright Center for Fetal Medicine, King's College Hospital, London, UK.

Institute of Health Research, University of Exeter, Exeter, UK.

出版信息

Ultrasound Obstet Gynecol. 2017 Jun;49(6):756-760. doi: 10.1002/uog.17455.

DOI:10.1002/uog.17455
PMID:28295782
Abstract

OBJECTIVE

To compare the performance of screening for pre-eclampsia (PE) based on risk factors from medical history, as recommended by NICE and ACOG, with the method proposed by The Fetal Medicine Foundation (FMF), which uses Bayes' theorem to combine the a-priori risk from maternal factors, derived by a multivariable logistic model, with the results of various combinations of biophysical and biochemical measurements.

METHODS

This was a prospective multicenter study of screening for PE in 8775 singleton pregnancies at 11-13 weeks' gestation. A previously published FMF algorithm was used for the calculation of patient-specific risk of PE in each individual. The detection rates (DRs) and false-positive rates (FPRs) for delivery with PE < 32, < 37 and ≥ 37 weeks were estimated and compared with those derived from application of NICE guidelines and ACOG recommendations. According to NICE, all high-risk pregnancies should be offered low-dose aspirin. According to ACOG, use of aspirin should be reserved for women with a history of PE in at least two previous pregnancies or PE requiring delivery < 34 weeks' gestation.

RESULTS

In the study population, 239 (2.7%) cases developed PE, of which 17 (0.2%), 59 (0.7%) and 180 (2.1%) developed PE < 32, < 37 and ≥ 37 weeks, respectively. Screening with use of the FMF algorithm based on a combination of maternal factors, mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) detected 100% (95% CI, 80-100%) of PE < 32 weeks, 75% (95% CI, 62-85%) of PE < 37 weeks and 43% (95% CI, 35-50%) of PE ≥ 37 weeks, at a 10.0% FPR. Screening with use of NICE guidelines detected 41% (95% CI, 18-67%) of PE < 32 weeks, 39% (95% CI, 27-53%) of PE < 37 weeks and 34% (95% CI, 27-41%) of PE ≥ 37 weeks, at 10.2% FPR. Screening with use of ACOG recommendations detected 94% (95% CI, 71-100%) of PE < 32 weeks, 90% (95% CI, 79-96%) of PE < 37 weeks and 89% (95% CI, 84-94%) of PE ≥ 37 weeks, at 64.2% FPR. Screening based on the ACOG recommendations for use of aspirin detected 6% (95% CI, 1-27%) of PE < 32 weeks, 5% (95% CI, 2-14%) of PE < 37 weeks and 2% (95% CI, 0.3-5%) of PE ≥ 37 weeks, at 0.2% FPR.

CONCLUSION

Performance of screening for PE at 11-13 weeks' gestation by the FMF algorithm using a combination of maternal factors, MAP, UtA-PI and PlGF, is by far superior to the methods recommended by NICE and ACOG. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

摘要

目的

比较按照英国国家卫生与临床优化研究所(NICE)和美国妇产科医师学会(ACOG)建议,基于病史风险因素进行的子痫前期(PE)筛查方法,与胎儿医学基金会(FMF)提出的方法。FMF方法使用贝叶斯定理,将多变量逻辑模型得出的母体因素先验风险与生物物理和生化测量的各种组合结果相结合。

方法

这是一项对8775例单胎妊娠在妊娠11 - 13周时进行PE筛查的前瞻性多中心研究。使用先前发表的FMF算法计算每个个体的PE患者特异性风险。估计并比较了妊娠<32周、<37周和≥37周分娩时的检出率(DRs)和假阳性率(FPRs),并与应用NICE指南和ACOG建议得出的结果进行比较。根据NICE,所有高危妊娠都应给予低剂量阿司匹林。根据ACOG,阿司匹林的使用应仅限于至少有两次既往PE病史或妊娠<34周需分娩的PE患者。

结果

在研究人群中,239例(2.7%)发生了PE,其中17例(0.2%)、59例(0.7%)和180例(2.1%)分别在妊娠<32周、<37周和≥37周时发生PE。使用基于母体因素、平均动脉压(MAP)、子宫动脉搏动指数(UtA - PI)和血清胎盘生长因子(PlGF)组合的FMF算法进行筛查,在FPR为10.0%时,检测到<32周PE的100%(95%CI,80 - 100%)、<37周PE的75%(95%CI,62 - 85%)和≥37周PE的43%(95%CI,35 - 50%)。使用NICE指南进行筛查,在FPR为10.2%时,检测到<32周PE的41%(95%CI,18 - 67%)、<37周PE的39%(95%CI,27 - 53%)和≥37周PE的34%(95%CI,27 - 41%)。使用ACOG建议进行筛查,在FPR为64.2%时,检测到<32周PE的94%(95%CI,71 - 100%)、<37周PE的90%(95%CI,79 - 96%)和≥37周PE的89%(95%CI,84 - 94%)。基于ACOG阿司匹林使用建议进行筛查,在FPR为0.2%时,检测到<32周PE的6%(95%CI,1 - 27%)、<37周PE的5%(95%CI,2 - 14%)和≥37周PE的2%(95%CI,0.3 - 5%)。

结论

在妊娠11 - 13周时,使用母体因素、MAP、UtA - PI和PlGF组合的FMF算法进行PE筛查的性能,远优于NICE和ACOG推荐的方法。版权所有©2017国际妇产科超声学会。由约翰·威利父子有限公司出版。

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