Arai Y, Onishi H, Oishi K, Takeuchi H, Yoshida O
Department of Urology, Faculty of Medicine, Kyoto University.
Jpn J Clin Oncol. 1993 Apr;23(2):110-5.
We have developed a new hypersensitive enzyme immunoassay for prostate specific antigen (PSA) based on the (MARKIT-M PA) assay but employing a two-hour incubation of the primary monoclonal antibody. The analytical sensitivity has been determined at 0.2 ng/ml, calculated as the mean+three standard deviations of the zero calibrator. Serum PSA was measured at least one month after radical prostatectomy (nine patients) or cystoprostatectomy (six patients). Based on the PSA levels of these patients, the recommended PSA cut-off level indicative of residual disease after radical prostatectomy was 0.4 ng/ml. Increasing (> 0.4 ng/ml) PSA levels preceded recurrence by eight months in a patient who developed bone metastasis after radical prostatectomy. In two patients treated with endocrine therapy, increasing PSA levels also preceded clinical evidence of progression by between eight and nine months. The study suggests that the newly developed sensitive PSA assay allows for the identification of patients with disease progression and the early commencement of adjuvant treatment.
我们基于（MARKIT-M PA）检测法开发了一种新的前列腺特异性抗原（PSA）超敏酶免疫测定法，但采用了一抗两小时孵育的方法。分析灵敏度测定为0.2 ng/ml，计算方法是零校准品的平均值加三个标准差。在根治性前列腺切除术（9例患者）或膀胱前列腺切除术（6例患者）后至少一个月测量血清PSA。根据这些患者的PSA水平，根治性前列腺切除术后提示残留疾病的推荐PSA临界值为0.4 ng/ml。一名根治性前列腺切除术后发生骨转移的患者，PSA水平升高（>0.4 ng/ml）比复发提前8个月。在两名接受内分泌治疗的患者中，PSA水平升高也比临床进展证据提前8至9个月。该研究表明，新开发的灵敏PSA检测法能够识别疾病进展的患者，并能早期开始辅助治疗。
