McLernon David J, Donnan Peter T, Gray Mike, Weller David, Sullivan Frank
Tayside Centre for General Practice, Community Health Sciences, University of Dundee, Ninewells Hospital and Medical School, Dundee DD2 4AD, Scotland.
J Med Screen. 2006;13(2):102-7. doi: 10.1258/096914106777589614.
To determine the operating characteristics of prostate-specific antigen (PSA) testing and prostate cancer diagnosis rates in men who have had an initial PSA test in Tayside.
A retrospective cohort study in Tayside, Scotland from 1992 to 2001.
In total, 20,623 men were PSA tested during the period 1992-2001. After exclusions, 19,660 were studied. Sensitivity and specificity were calculated for various PSA cut-off values by age group using logistic regression weighted for verification bias (biopsy). Cox regression analysis was performed using six test pattern cohorts.
The annual rate of PSA testing increased from 5.1 per 1000 man years in 1992 to 21.3 per 1000 man years in 2001. The average number of PSA tests per patient increased from 1.11 in 1992 to 2.57 in 2001. Prostate cancer diagnosis and death rates remained constant from 1995 onward. The PSA test had generally inadequate sensitivity and specificity values, so a unique cut-off could not be found for the two older age groups which could be used as a recommendation for biopsy. The commonly used 4 ng/mL cut-off was reasonably sensitive and specific only for the under 60 age group with values of 92.4% and 90.7%, respectively. For prostate cancer diagnosis, the hazard ratios (HR) were reported relative to those with a series of all normal tests. For those with an initially normal PSA test who had at least one abnormal retest result the HR for diagnosis was 10.43 (95% confidence interval [CI] 6.17-17.63). For those with initially abnormal tests with normal retests HR = 1.63 (95% CI 0.65-4.07).
There are no optimal PSA cut-off values for older age groups with which to make a confident referral for biopsy. The increase in PSA testing and the questionable cut-off values of the test calls for the development of an alternative screening strategy.
确定泰赛德地区初次进行前列腺特异性抗原（PSA）检测的男性中PSA检测的操作特征及前列腺癌诊断率。
1992年至2001年在苏格兰泰赛德地区进行的一项回顾性队列研究。
1992年至2001年期间共有20623名男性接受了PSA检测。排除部分病例后，对19660名男性进行了研究。采用逻辑回归对验证偏倚（活检）进行加权，计算不同年龄组各种PSA临界值的敏感性和特异性。使用六个检测模式队列进行Cox回归分析。
PSA检测的年发生率从1992年的每1000人年5.1次增加到2001年的每1000人年21.3次。每位患者的平均PSA检测次数从1992年的1.11次增加到2001年的2.57次。自1995年起，前列腺癌的诊断率和死亡率保持稳定。PSA检测的敏感性和特异性值总体上不足，因此无法为两个年龄较大的组找到一个可用于活检推荐的唯一临界值。常用的4 ng/mL临界值仅对60岁以下年龄组具有合理的敏感性和特异性，分别为92.4%和90.7%。对于前列腺癌诊断，报告了相对于一系列所有检测结果均正常者的风险比（HR）。对于初次PSA检测正常但至少有一次复查结果异常者，诊断的HR为10.43（95%置信区间[CI] 6.17 - 17.63）。对于初次检测异常但复查正常者，HR = 1.63（95% CI 0.65 - 4.07）。
对于年龄较大的组，没有可用于自信地转诊进行活检的最佳PSA临界值。PSA检测的增加以及该检测临界值存在疑问，需要制定替代筛查策略。
