Reiter W, Stieber P, Schmeller N, Nagel D, Fateh-Moghadam A
Institut für Klinische Chemie, Klinikum Grosshadern, Ludwig-Maximilians-Universität München, Germany.
Anticancer Res. 1997 Nov-Dec;17(6D):4767-70.
This study examined the clinical relevance of the determination of alpha 1-antichymotrypsin complexed PSA (ACT-PSA) in addition to total PSA antigen (t-PSA).
Both total PSA- and ACT-PSA-values of frozen sera obtained pretherapeutically from 93 patients with carcinoma (PC) and 132 patients with benign hyperplasia of the prostate (BPH) were analyzed by means of PSA sandwich-ELISA (Dianova GmbH) and ACT-PSA sandwich-ELISA (Dianova GmbH).
At 95% specificity (true negative test results), a cutoff value of 18.9 [micrograms/L] was obtained for total PSA (7 patients with BPH [5%] were above this value). For this cutoff value we calculated a sensitivity (true positive test results) of 41%. Using the same criteria for the ratio Q = ACT-PSA: t-PSA (percentage of ACT-PSA) a cutoff of 6.0 was found again at a specificity of 95%. In a second step only patients with total PSA values below the cutoff level of 18.9 [micrograms/L]) were considered. Out of these patients 119 of 125 with BPH and 3 of 54 with PC were below the above mentioned ratio (Q = 6.0). Considering both steps (total PSA and Q) 42 patients with PC were detected correctly and 15 patients with BPH would have been biopsied unnecessarily.
High total PSA levels are a very good indicator for the presence of prostate cancer. There is still concern to improve the differentiation of the diagnosis between BPH and PC, when an intermediate or low value (< or = 95% specificity) is observed. The determination of Q = ACT-PSA: t-PSA is not to be recommended because it might not be helpful for the clinicians decision to perform biopsy.
本研究除检测总前列腺特异抗原(t-PSA)外,还检测了α1-抗糜蛋白酶复合前列腺特异抗原(ACT-PSA)的临床相关性。
采用PSA夹心酶联免疫吸附测定法(Dianova有限公司)和ACT-PSA夹心酶联免疫吸附测定法(Dianova有限公司),分析了93例前列腺癌(PC)患者和132例前列腺良性增生(BPH)患者治疗前采集的冷冻血清中的总PSA值和ACT-PSA值。
在特异性为95%(真阴性检测结果)时,总PSA的临界值为18.9[μg/L](7例BPH患者[5%]高于此值)。对于该临界值,我们计算出的敏感性(真阳性检测结果)为41%。采用相同标准计算ACT-PSA与t-PSA的比值Q(ACT-PSA的百分比),在特异性为95%时,再次发现临界值为6.0。第二步仅考虑总PSA值低于18.9[μg/L]临界水平的患者。在这些患者中,125例BPH患者中有119例以及54例PC患者中有3例低于上述比值(Q = 6.0)。综合两个步骤(总PSA和Q),42例PC患者被正确检测出,15例BPH患者可能会接受不必要的活检。
总PSA水平高是前列腺癌存在的一个很好的指标。当观察到中间值或低值(≤95%特异性)时,在改善BPH和PC诊断的鉴别方面仍存在问题。不建议测定Q = ACT-PSA:t-PSA,因为它可能无助于临床医生决定是否进行活检。