PRERISK研究：一项评估基于可溶性血管内皮生长因子受体-1/胎盘生长因子的子痫前期住院计算器的随机对照试验。
PRERISK Study: A Randomized Controlled Trial Evaluating a sFlt-1/PlGF-Based Calculator for Preeclampsia Hospitalization.
作者信息
Kluivers Anna C M, Neuman Rugina I, Saleh Langeza, Russcher Henk, Brussé Ingrid A, Cornette Jerome M J, Steegers Eric A P, van der Weide Marijke C, van Drongelen Joris, Scholten Ralph R, van Herwaarden Antonius E, Gordijn Sanne J, Muller Kobold Anneke C, Ganzevoort Wessel, Wesselius Sharon M, de Rotte Maurits C F J, Aardenburg Robert, Raijmakers Maarten, Visser Willy, Danser A H Jan
机构信息
Department of Internal Medicine, Division of Pharmacology and Vascular Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands (A.C.M. Kluivers, R.I.N., W.V., A.H.J.D.).
Department of Obstetrics and Gynecology, Division Obstetrics and Fetal Medicine, Erasmus MC, University Medical Center, Rotterdam, the Netherlands (A.C.M. Kluivers, L.S., I.A.B., J.M.J.C., E.A.P.S.).
出版信息
Hypertension. 2025 May;82(5):827-838. doi: 10.1161/HYPERTENSIONAHA.124.24386. Epub 2025 Apr 16.
BACKGROUND
A model based on the soluble Fms-like tyrosine kinase-1/placental growth factor ratio, gestational age, and the urinary protein-to-creatinine ratio (PRERISK calculator) has been developed to predict preeclampsia-related maternal-fetal complications. Here, we tested whether this model can reduce hospital admissions without increasing complication rates among women with suspected or confirmed preeclampsia.
METHODS
In this multicenter, open-label, randomized controlled trial conducted at 5 Dutch medical centers, women with suspected or confirmed preeclampsia were randomly assigned to the intervention group, where admission was guided by the PRERISK score using a 5% cutoff, or to the control group receiving routine care with a concealed PRERISK score. Two co-primary outcomes were the incidence of maternal-fetal preeclampsia-related complications (noninferiority) and the proportion of women with a hospitalization ratio (=admission days/inclusion days) ≤0.05 (superiority).
RESULTS
The intervention and control groups included 442 and 435 women, respectively. In the intention-to-treat analysis, complications occurred in 41.6% of the intervention group versus 39.5% of the control group (adjusted relative risk 1.06 [95% CI, 0.92-1.22]; =0.43). The proportion of women achieving a hospitalization ratio ≤0.05 was 23.6% in the intervention group and 26.3% in the control group (adjusted relative risk, 0.89 [95% CI, 0.71-1.13]; =0.34). The latter was comparable in the per-protocol analysis (adjusted relative risk, 0.87 [95% CI, 0.64-1.19]; =0.38), while in this analysis, complications occurred in 47.8% of the intervention group (n=251) versus 41.7% of the control group (n=365; adjusted relative risk 1.19 [95% CI, 1.03-1.38]; =0.02).
CONCLUSIONS
Routine screening with the PRERISK score and a 5% cutoff in patients with suspected or confirmed preeclampsia does not decrease hospitalization and is therefore not recommended.
REGISTRATION
URL: https://onderzoekmetmensen.nl/nl/trial/48687; Unique identifier: NL63386.078.17, NL-OMON48687.
背景
基于可溶性Fms样酪氨酸激酶-1/胎盘生长因子比值、孕周和尿蛋白与肌酐比值（PRERISK计算器）开发了一种模型，用于预测子痫前期相关的母婴并发症。在此，我们测试了该模型能否在不增加疑似或确诊子痫前期女性并发症发生率的情况下减少住院次数。
方法
在荷兰5家医疗中心进行的这项多中心、开放标签、随机对照试验中，疑似或确诊子痫前期的女性被随机分配到干预组，该组根据PRERISK评分（采用5%的临界值）指导入院，或分配到接受常规护理且PRERISK评分保密的对照组。两个共同主要结局是母婴子痫前期相关并发症的发生率（非劣效性）和住院率（=住院天数/纳入天数）≤0.05的女性比例（优效性）。
结果
干预组和对照组分别纳入442名和435名女性。在意向性分析中，干预组41.6%的女性发生并发症，对照组为39.5%（调整后的相对风险1.06 [95% CI，0.92 - 1.22]；P = 0.43）。住院率≤0.05的女性比例在干预组为23.6%，在对照组为26.3%（调整后的相对风险，0.89 [95% CI，0.71 - 1.13]；P = 0.34）。在符合方案分析中结果相当（调整后的相对风险，0.87 [95% CI，0.64 - 1.19]；P = 0.38），而在此分析中，干预组47.8%的女性（n = 251）发生并发症，对照组为41.7%（n = 365；调整后的相对风险1.19 [95% CI，1.03 - 1.38]；P = 0.02）。
结论
对疑似或确诊子痫前期患者采用PRERISK评分及5%的临界值进行常规筛查并不能减少住院次数，因此不推荐使用。
注册信息
网址：https://onderzoekmetmensen.nl/nl/trial/48687；唯一标识符：NL63386.078.17，NL - OMON48687 。
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