Burghaus Stefanie, Drazic Predrag, Wölfler Monika, Mechsner Sylvia, Zeppernick Magdalena, Meinhold-Heerlein Ivo, Mueller Michael D, Rothmund Ralf, Vigano Paola, Becker Christian M, Zondervan Krina T, Beckmann Matthias W, Fasching Peter A, Berner-Gatz Sibylle, Grünewald Felix S, Hund Martin, Kastner Peter, Klammer Martin, Laubender Ruediger P, Wegmeyer Heike, Wienhues-Thelen Ursula-Henrike, Renner Stefan P
Department of Gynecology and Obstetrics, Erlangen University Hospital, University Endometriosis Center for Franconia, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.
Endometriosis Center, Ammerland Clinic GmbH, Westerstede, Germany.
Int J Gynaecol Obstet. 2024 Jan;164(1):305-314. doi: 10.1002/ijgo.15062. Epub 2023 Aug 28.
To evaluate blood-based biomarkers to detect endometriosis and/or adenomyosis across nine European centers (June 2014-April 2018).
This prospective, non-interventional study assessed the diagnostic accuracy of 54 blood-based biomarker immunoassays in samples from 919 women (aged 18-45 years) with suspicion of endometriosis and/or adenomyosis versus symptomatic controls. Endometriosis was stratified by revised American Society for Reproductive Medicine stage. Symptomatic controls were "pathologic symptomatic controls" or "pathology-free symptomatic controls". The main outcome measure was receiver operating characteristic-area under the curve (ROC-AUC) and Wilcoxon P values corrected for multiple testing (q values).
CA-125 performed best in "all endometriosis cases" versus "all symptomatic controls" (AUC 0.645, 95% confidence interval [CI] 0.600-0.690, q < 0.001) and increased (P < 0.001) with disease stage. In "all endometriosis cases" versus "pathology-free symptomatic controls", S100-A12 performed best (AUC 0.692, 95% CI 0.614-0.769, q = 0.001) followed by CA-125 (AUC 0.649, 95% CI 0.569-0.729, q = 0.021). In "adenomyosis only cases" versus "symptomatic controls" or "pathology-free symptomatic controls", respectively, the top-performing biomarkers were sFRP-4 (AUC 0.615, 95% CI 0.551-0.678, q = 0.045) and S100-A12 (AUC 0.701, 95% CI 0.611-0.792, q = 0.004).
This study concluded that no biomarkers tested could diagnose or rule out endometriosis/adenomyosis with high certainty.
评估血液生物标志物在九个欧洲中心（2014年6月至2018年4月）检测子宫内膜异位症和/或子宫腺肌病的情况。
这项前瞻性、非干预性研究评估了54种基于血液的生物标志物免疫测定法在919名怀疑患有子宫内膜异位症和/或子宫腺肌病的女性（年龄18 - 45岁）与有症状对照者样本中的诊断准确性。子宫内膜异位症根据修订的美国生殖医学协会分期进行分层。有症状对照者为“病理性有症状对照者”或“无病理有症状对照者”。主要结局指标是受试者工作特征曲线下面积（ROC - AUC）以及针对多重检验校正的Wilcoxon P值（q值）。
在“所有子宫内膜异位症病例”与“所有有症状对照者”对比中，CA - 125表现最佳（AUC 0.645，95%置信区间[CI] 0.600 - 0.690，q < 0.001），且随疾病分期升高（P < 0.001）。在“所有子宫内膜异位症病例”与“无病理有症状对照者”对比中，S100 - A12表现最佳（AUC 0.692，95% CI 0.614 - 0.769，q = 0.001），其次是CA - 125（AUC 0.649，95% CI 0.569 - 0.729，q = 0.021）。在“仅子宫腺肌病病例”分别与“有症状对照者”或“无病理有症状对照者”对比中，表现最佳的生物标志物分别是sFRP - 4（AUC 0.615，95% CI 0.551 - 0.678，q = 0.045）和S100 - A12（AUC 0.701，95% CI 0.611 - 0.792，q = 0.004）。
本研究得出结论，所检测的生物标志物均无法高度确定地诊断或排除子宫内膜异位症/子宫腺肌病。
