Becker C, Piironen T, Pettersson K, Björk T, Wojno K J, Oesterling J E, Lilja H
Department of Clinical Chemistry, Lund University, University Hospital Malmö, Sweden.
J Urol. 2000 Jan;163(1):311-6.
To investigate the clinical value of measuring human glandular kallikrein 2 (hK2) compared with free and total prostate specific antigen (PSA-F and PSA-T) in serum from patients with prostate disease.
Serum from healthy controls, from men with benign prostate hyperplasia (BPH), clinically localized prostate cancer (PCa), and advanced PCa were analyzed for hK2 (using an in-house-research assay with detection limit of 0.05 ng./mL and <0.1% cross-reaction with PSA) and for PSA-F and PSA-T (using the Dual Prostatus assay from EG&G Wallac).
HK2 concentrations were <0.05 ng./mL in 50/50 healthy volunteers but significantly higher (p <0.0001) and > or =0.05 ng./mL in 28/54 (52%) patients with BPH. In comparison to these men, the hK2 levels were significantly higher (p <0.0001, median 0.085 ng./mL) and > or =0.05 ng./mL in 100/136 (74%) men with clinically localized PCa. Compared with localized PCa, the hK2 levels were significantly higher (p <0.0001, median 0.57 ng./mL) and > or =0.05 ng./mL in 55/57 (96%) patients with advanced PCa. The median hK2 levels ranged from 1.3 to 1.6% of those of PSA-T in all three patient groups, whereas percent hK2/PSA-F and hK2 x PSA-T/PSA-F levels were significantly higher in cancer patients compared with those with BPH. In the discrimination of clinically localized PCa from BPH, hK2 x PSA-T/PSA-F gave the largest area under the receiver operating curve (AUC = 0.81) and significantly (p = 0.025) larger AUC than PSA-T alone (0.70). Further, at 95% sensitivity there was significant gain in specificity, and at specificity levels of 90 to 95% there was significant gain in sensitivity using the measurements of PSA-T+PSA-F+hK2 compared with analysis of PSA-T and/or percent free PSA.
Discrimination of patients with benign prostate disease from those with prostate cancer was significantly enhanced using measurements of hK2 in addition to those of PSA-T and PSA-F. Percent hK2/PSA-F was higher in PCa than in BPH, a phenomena not yet understood.
探讨检测人组织激肽释放酶2（hK2）相较于检测前列腺疾病患者血清中的游离前列腺特异性抗原（PSA-F）和总前列腺特异性抗原（PSA-T）的临床价值。
分析健康对照者、良性前列腺增生（BPH）患者、临床局限性前列腺癌（PCa）患者及晚期PCa患者血清中的hK2（采用内部研究检测方法，检测限为0.05 ng/mL，与PSA的交叉反应<0.1%）以及PSA-F和PSA-T（采用EG&G Wallac公司的双参数前列腺检测法）。
50名健康志愿者的HK2浓度<0.05 ng/mL，但28名（52%）BPH患者的HK2浓度显著更高（p<0.0001）且≥0.05 ng/mL。与这些男性相比，100名（74%）临床局限性PCa男性的hK2水平显著更高（p<0.0001，中位数为0.085 ng/mL）且≥0.05 ng/mL。与局限性PCa患者相比，55名（96%）晚期PCa患者的hK2水平显著更高（p<0.0001，中位数为0.57 ng/mL）且≥0.05 ng/mL。在所有三组患者中，hK2的中位数水平为PSA-T的1.3%至1.6%，而癌症患者的hK2/PSA-F百分比和hK2×PSA-T/PSA-F水平显著高于BPH患者。在鉴别临床局限性PCa与BPH时，hK2×PSA-T/PSA-F在受试者操作特征曲线下的面积最大（AUC = 0.81），且显著（p = 0.025）大于单独的PSA-T（0.70）。此外，在95%的敏感度下，特异性有显著提高；在90%至95%的特异性水平下，与PSA-T和/或游离PSA百分比分析相比，使用PSA-T + PSA-F + hK2测量时敏感度有显著提高。
除检测PSA-T和PSA-F外，检测hK2可显著提高鉴别前列腺良性疾病患者与前列腺癌患者的能力。PCa患者的hK2/PSA-F百分比高于BPH患者，这一现象尚不清楚。
