Pambet Mathilde, Sirodot Fanny, Pereira Bruno, Cahierc Romain, Delabaere Amélie, Comptour Aurélie, Rouzaire Marion, Sapin Vincent, Gallot Denis
CIC 1405 CRECHE Unit, INSERM, Obstetrics and Gynaecology Department, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Biostatistics Unit, Direction de la Recherche Clinique et de l'Innovation (DRCI), CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
J Clin Med. 2023 Sep 1;12(17):5707. doi: 10.3390/jcm12175707.
We conducted a prospective double-blind study to compare two vaginal diagnostic methods in singleton pregnancies with threatened preterm labor (TPL) at the University Hospital of Clermont-Ferrand (France) from August 2018 to December 2020. Our main objective was to compare the diagnostic capacity at admission, in terms of positive predictive value (PPV) and negative predictive value (NPV), of Premaquick (combined detection of IL-6/total IGFBP-1/native IGFBP-1) and QuikCheck fFN™ (fetal fibronectin) for delivery within 7 days in cases of TPL. We included 193 patients. Premaquick had a sensitivity close to 89%, equivalent to QuikCheck fFN™, but a higher statistical specificity of 49.5% against 38.6% for QuikCheck fFN™. We found no superiority of Premaquick over QuickCheck fFN™ in terms of PPV (6.6% vs. 7.9%), with NPV being equivalent in predicting childbirth within 7 days in cases of TPL (98.6% vs. 98.9%). Nevertheless, the combination of positive native and total IGFBP-1 and the combination of all three positive markers were associated with a higher PPV. Our results, though non-significant, support this combined multiple-biomarker approach to improve testing in terms of predictive values.
2018年8月至2020年12月，我们在法国克莱蒙费朗大学医院进行了一项前瞻性双盲研究，比较单胎妊娠合并先兆早产（TPL）时的两种阴道诊断方法。我们的主要目标是比较Premaquick（白细胞介素-6/总胰岛素样生长因子结合蛋白-1/天然胰岛素样生长因子结合蛋白-1联合检测）和QuikCheck fFN™（胎儿纤连蛋白）在TPL病例中预测7天内分娩的入院诊断能力，以阳性预测值（PPV）和阴性预测值（NPV）衡量。我们纳入了193名患者。Premaquick的敏感性接近89%，与QuikCheck fFN™相当，但统计学特异性更高，分别为49.5%和38.6%。在PPV方面（6.6%对7.9%），我们发现Premaquick并不优于QuickCheck fFN™，在预测TPL病例7天内分娩的NPV方面两者相当（98.6%对98.9%）。然而，天然和总胰岛素样生长因子结合蛋白-1均为阳性以及三种标志物均为阳性的组合与更高的PPV相关。我们的结果虽无统计学意义，但支持这种联合多种生物标志物的方法在预测值方面改善检测。
