用于检测子宫内膜异位症和子宫腺肌病的血液生物标志物的多中心评估：一项前瞻性非干预性研究。
Multicenter evaluation of blood-based biomarkers for the detection of endometriosis and adenomyosis: A prospective non-interventional study.
作者信息
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
机构信息
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.
出版信息
Int J Gynaecol Obstet. 2024 Jan;164(1):305-314. doi: 10.1002/ijgo.15062. Epub 2023 Aug 28.
OBJECTIVE
To evaluate blood-based biomarkers to detect endometriosis and/or adenomyosis across nine European centers (June 2014-April 2018).
METHODS
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).
RESULTS
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).
CONCLUSION
This study concluded that no biomarkers tested could diagnose or rule out endometriosis/adenomyosis with high certainty.
目的
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。
方法
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）。
结果
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）。
结论
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。
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