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NICE 指南指导下的早期子痫前期筛查诊断准确性比较及联合母体外周血标志物和母体因素的方法:SPREE 研究结果。

Comparison of diagnostic accuracy of early screening for pre-eclampsia by NICE guidelines and a method combining maternal factors and biomarkers: results of SPREE.

机构信息

King's College Hospital, London, UK.

University Hospital Lewisham, London, UK.

出版信息

Ultrasound Obstet Gynecol. 2018 Jun;51(6):743-750. doi: 10.1002/uog.19039. Epub 2018 Mar 14.

DOI:10.1002/uog.19039
PMID:29536574
Abstract

OBJECTIVE

To test the hypothesis that the performance of first-trimester screening for pre-eclampsia (PE) by a method that uses Bayes' theorem to combine maternal factors with biomarkers is superior to that defined by current National Institute for Health and Care Excellence (NICE) guidelines.

METHODS

This was a prospective multicenter study (screening program for pre-eclampsia (SPREE)) in seven National Health Service maternity hospitals in England, of women recruited between April and December 2016. Singleton pregnancies at 11-13 weeks' gestation had recording of maternal characteristics and medical history and measurements of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI), serum placental growth factor (PlGF) and serum pregnancy-associated plasma protein-A (PAPP-A). The performance of screening for PE by the Bayes' theorem-based method was compared with that of the NICE method. Primary comparison was detection rate (DR) using NICE method vs mini-combined test (maternal factors, MAP and PAPP-A) in the prediction of PE at any gestational age (all-PE) for the same screen-positive rate determined by the NICE method. Key secondary comparisons were DR of screening recommended by the NICE guidelines vs three Bayes' theorem-based methods (maternal factors, MAP and PAPP-A; maternal factors, MAP and PlGF; and maternal factors, MAP, UtA-PI and PlGF) in the prediction of preterm PE, defined as that requiring delivery < 37 weeks.

RESULTS

All-PE developed in 473 (2.8%) of the 16 747 pregnancies and preterm PE developed in 142 (0.8%). The screen-positive rate by the NICE method was 10.3% and the DR for all-PE was 30.4% and for preterm PE it was 40.8%. Compliance with the NICE recommendation that women at high risk for PE should be treated with aspirin from the first trimester to the end of pregnancy was only 23%. The DR of the mini-combined test for all-PE was 42.5%, which was superior to that of the NICE method by 12.1% (95% CI, 7.9-16.2%). In screening for preterm PE by a combination of maternal factors, MAP and PlGF, the DR was 69.0%, which was superior to that of the NICE method by 28.2% (95% CI, 19.4-37.0%) and with the addition of UtA-PI the DR was 82.4%, which was higher than that of the NICE method by 41.6% (95% CI, 33.2-49.9%).

CONCLUSIONS

The performance of screening for PE as currently recommended by NICE guidelines is poor and compliance with these guidelines is low. The performance of screening is substantially improved by a method combining maternal factors with biomarkers. © 2018 Crown copyright. Ultrasound in Obstetrics & Gynecology © 2018 ISUOG.

摘要

目的

验证以下假设,即使用贝叶斯定理结合母体因素和生物标志物的方法对早孕期子痫前期(PE)进行筛查的性能优于当前英国国家卫生与保健卓越研究所(NICE)指南所定义的方法。

方法

这是在英格兰 7 家国民保健制度产科医院进行的一项前瞻性多中心研究(早孕期子痫前期筛查项目(SPREE)),纳入了 2016 年 4 月至 12 月间的 11-13 孕周的单胎妊娠孕妇。记录母体特征和病史,测量平均动脉压(MAP)、子宫动脉搏动指数(UtA-PI)、血清胎盘生长因子(PlGF)和血清妊娠相关血浆蛋白-A(PAPP-A)。贝叶斯定理法筛查 PE 的性能与 NICE 方法进行比较。主要比较是 NICE 方法的检测率(DR)与迷你联合检测(母体因素、MAP 和 PAPP-A)在预测任何孕龄(所有 PE)PE 方面的表现,该检测率通过 NICE 方法确定。关键次要比较是 NICE 指南推荐的筛查与三种基于贝叶斯定理的方法(母体因素、MAP 和 PAPP-A;母体因素、MAP 和 PlGF;以及母体因素、MAP、UtA-PI 和 PlGF)在预测早产 PE 方面的 DR,早产 PE 定义为需要在 37 周前分娩。

结果

16747 例妊娠中共有 473 例(2.8%)发生了所有 PE,142 例(0.8%)发生了早产 PE。NICE 方法的筛查阳性率为 10.3%,所有 PE 的 DR 为 30.4%,早产 PE 的 DR 为 40.8%。仅 23%的孕妇符合 NICE 建议,即高危 PE 孕妇应从孕早期开始至孕晚期一直服用阿司匹林。迷你联合检测对所有 PE 的 DR 为 42.5%,比 NICE 方法高 12.1%(95%CI,7.9-16.2%)。用母体因素、MAP 和 PlGF 联合筛查早产 PE 的 DR 为 69.0%,比 NICE 方法高 28.2%(95%CI,19.4-37.0%),加入 UtA-PI 后 DR 为 82.4%,比 NICE 方法高 41.6%(95%CI,33.2-49.9%)。

结论

目前 NICE 指南推荐的 PE 筛查性能不佳,且对这些指南的依从性低。通过结合母体因素和生物标志物的方法,筛查性能得到了显著改善。 © 2018 英国版权。超声医学与妇产科 © 2018 ISUOG。

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