Dalkin B L, Ahmann F R, Kopp J B, Catalona W J, Ratliff T L, Hudson M A, Richie J P, Scardino P T, Flanigan R C, Dekernion J B
Division of Urology, University of Arizona, College of Medicine, Tucson, USA.
Br J Urol. 1995 Sep;76(3):346-50. doi: 10.1111/j.1464-410x.1995.tb07712.x.
To derive age-specific upper limits for prostate specific antigen (PSA) level in men 50-74 years of age with no clinical evidence of prostatic carcinoma, and to test the sensitivity and specificity for cancer detection of these upper limits.
A total of 6166 men were recruited for a multicentre study of prostate cancer detection and underwent a serum PSA determination and digital rectal examination (DRE). Men considered to be clinically free of prostatic carcinoma were those with a normal DRE and a PSA level < or = 4.0 ng/mL, and men with an abnormality in either parameter who underwent ultrasonography-guided prostate biopsy that revealed no evidence of carcinoma. By these criteria, 5469 men had no evidence of prostatic carcinoma. Dividing the population into 5-year age increments, three statistical methods were assessed to derive upper limits for serum PSA level by age; the mean +2 SD, the 99th percentile, and a 97.5% prediction interval based on linear regression.
Newly-derived upper limits calculated by each method in the 50-54 and the 70-74 age group were 3.9 ng/mL and 7.6 ng/mL (mean +2 SD), 5.2 ng/mL and 14.0 ng/mL (99th percentile), and 4.7 ng/mL and 8.2 ng/mL (97.5% prediction interval). The sensitivity of the newly-derived upper limits was tested using receiver operating characteristic curves derived from men with no suspicious findings on DRE and a serum PSA concentration > 4.0 ng/mL. Although the specificity of the test increased with increasing PSA upper limits, no upper limits derived from these three methods yielded adequate sensitivity to detect cancer; sensitivities by age range were from 53 to 94%, using mean +2 SD, from 25 to 50% with the 99th percentile, and from 47 to 64% with the 97.5% prediction interval.
We do not recommend age-referenced adjustments in upper limits for serum PSA concentration, but recommend that an upper limit of 4.0 ng/mL be used in all men 50-74 years of age.
得出50 - 74岁无前列腺癌临床证据男性的前列腺特异性抗原（PSA）水平的年龄特异性上限，并测试这些上限对癌症检测的敏感性和特异性。
共招募6166名男性参与一项前列腺癌检测的多中心研究，并进行血清PSA测定和直肠指检（DRE）。临床上被认为无前列腺癌的男性是指DRE正常且PSA水平≤4.0 ng/mL的男性，以及任何一项参数异常但经超声引导下前列腺活检未发现癌症证据的男性。根据这些标准，5469名男性无前列腺癌证据。将人群按5岁年龄增量划分，评估三种统计方法以得出各年龄段血清PSA水平的上限；均值 +2标准差、第99百分位数以及基于线性回归的97.5%预测区间。
在50 - 54岁和70 - 74岁年龄组中，每种方法计算得出的新上限分别为3.9 ng/mL和7.6 ng/mL（均值 +2标准差）、5.2 ng/mL和14.0 ng/mL（第99百分位数）、4.7 ng/mL和8.2 ng/mL（97.5%预测区间）。使用从DRE无可疑发现且血清PSA浓度>4.0 ng/mL的男性得出的受试者工作特征曲线来测试新上限的敏感性。尽管检测的特异性随PSA上限增加而提高，但这三种方法得出的上限均未产生足够的敏感性来检测癌症；按年龄范围的敏感性，使用均值 +2标准差时为53%至94%，使用第99百分位数时为25%至50%，使用97.5%预测区间时为47%至64%。
我们不建议对血清PSA浓度上限进行年龄相关调整，而是建议在所有50 - 74岁男性中使用4.0 ng/mL的上限。
