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临床实践中前列腺癌检测的临床性能评估。

Evaluation of Clinical Performance for the Detection of Prostate Cancer in Routine Clinical Practice.

机构信息

Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.

Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA

出版信息

Ann Clin Lab Sci. 2021 Jan;51(1):3-11.

PMID:33653775
Abstract

Prostate Health Index () and percent free PSA (%fPSA) are used in patients with a PSA concentration between 4-10 μg/L as an aid to distinguish prostate cancer (PCa) from benign conditions, and to assist in the decision of whether to proceed to biopsy. This study assesses the clinical performance and diagnostic accuracy of versus %fPSA in a cohort of Mayo Clinic's patients. Of 4065 orders received from May 2017-August 2018, concordance between and %fPSA results was evaluated on 2845 results with a total PSA within 4-10 μg/L. Retrospective chart review was performed on 201 Mayo Clinic patients, and %fPSA and results were compared with both the decision to biopsy and presence of PCa at biopsy. Receiver operating characteristic (ROC) curve analysis to evaluate the diagnostic accuracy of PSA, %fPSA and was performed. In this study 2.5% of the 2845 orders exhibited discordant PCa risk classifications between %fPSA and results. In the high risk category, 41.7% (versus 26.1% by %fPSA) of patients had biopsy and 100% (versus 66.6% by %fPSA) were positive for PCa. exhibited the highest specificity and ROC area under the curve compared to %fPSA and PSA. was a better predictor than %fPSA for finding PCa at biopsy. These findings support continued utilization of in the evaluation of patients with a PSA in the 4-10 μg/L range.

摘要

前列腺健康指数()和游离前列腺特异性抗原百分比(%fPSA)用于 PSA 浓度在 4-10μg/L 之间的患者,以帮助区分前列腺癌(PCa)和良性疾病,并协助决定是否进行活检。本研究评估了在 Mayo 诊所患者队列中,与 %fPSA 相比,在临床性能和诊断准确性。在 2017 年 5 月至 2018 年 8 月期间收到的 4065 份订单中,对总 PSA 在 4-10μg/L 之间的 2845 份结果进行了评估,以评估与 %fPSA 结果的一致性。对 201 例 Mayo 诊所患者进行了回顾性图表审查,并比较了 %fPSA 和 结果与活检决策和活检时 PCa 的存在。进行了接收器工作特性(ROC)曲线分析,以评估 PSA、%fPSA 和 的诊断准确性。在这项研究中,2.5%的 2845 份订单显示 %fPSA 和 结果之间存在 PCa 风险分类不一致。在高危类别中,41.7%(与 %fPSA 的 26.1%相比)的患者进行了活检,100%(与 %fPSA 的 66.6%相比)的患者 PCa 阳性。与 %fPSA 和 PSA 相比,显示出最高的特异性和 ROC 曲线下面积。与 %fPSA 相比,对于在活检中发现 PCa,更能预测。这些发现支持在 PSA 处于 4-10μg/L 范围内的患者评估中继续使用 。

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