Oesterling J E, Jacobsen S J, Cooner W H
Department of Urology, Mayo Clinic, Rochester, Minnesota.
J Urol. 1995 Apr;153(4):1160-3.
Several investigations have determined that the serum prostate specific antigen (PSA) concentration is dependent upon patient age and, as a result, reference ranges wider than 0.0 to 4.0 ng./ml. have been suggested for men 60 years old or older. To determine the clinical usefulness of the age-specific reference ranges--0.0 to 4.5 ng./ml. for men 60 to 69 years old and 0.0 to 6.5 ng./ml. for men 70 years old or older--the medical records of 2,988 men 60 years old or older who presented to a single urological practice were examined. All patients were evaluated with a serum PSA determination, digital rectal examination and transrectal ultrasound. A total of 1,686 prostate biopsies was performed (biopsy rate 56%) and 608 cancers were diagnosed (cancer detection rate 20%). By using the age-specific reference ranges as compared to the 0.0 to 4.0 ng./ml. reference range, the sensitivity of PSA for detecting early prostate cancer decreased by 9%, while the specificity and positive predictive value increased by 11% and 5%, respectively. If the age-specific reference ranges had been used 92 prostate biopsies (5.5%) performed could have been avoided, while 19 men in the study population (0.6%) would not have had prostate cancer diagnosed. Of the nondetected cancers 13 (67%) occurred in men 70 years old or older and 18 (95%) were small tumors of favorable pathological status unlikely to be of clinical consequence in these older men. These preliminary findings support the clinical usefulness of the wider age-specific reference ranges in men 60 years old or older. A prospective randomized clinical trial is currently underway to confirm the appropriateness of age-specific reference ranges compared to the reference range of 0.0 to 4.0 ng./ml.
多项研究已确定，血清前列腺特异性抗原（PSA）浓度取决于患者年龄，因此，对于60岁及以上男性，建议采用比0.0至4.0 ng/ml更宽的参考范围。为了确定特定年龄参考范围（60至69岁男性为0.0至4.5 ng/ml，70岁及以上男性为0.0至6.5 ng/ml）的临床实用性，对一家泌尿外科诊所就诊的2988名60岁及以上男性的病历进行了检查。所有患者均接受了血清PSA测定、直肠指检和经直肠超声检查。共进行了1686次前列腺活检（活检率56%），诊断出608例癌症（癌症检出率20%）。与0.0至4.0 ng/ml的参考范围相比，使用特定年龄参考范围时，PSA检测早期前列腺癌的敏感性降低了9%，而特异性和阳性预测值分别提高了11%和5%。如果使用特定年龄参考范围，本可避免92次（5.5%）前列腺活检，而研究人群中有19名男性（0.6%）不会被诊断出患有前列腺癌。在未检测出的癌症中，13例（67%）发生在70岁及以上男性中，18例（95%）是病理状态良好的小肿瘤，在这些老年男性中不太可能产生临床后果。这些初步研究结果支持了更宽的特定年龄参考范围对60岁及以上男性的临床实用性。目前正在进行一项前瞻性随机临床试验，以确认特定年龄参考范围与0.0至4.0 ng/ml参考范围相比的适宜性。
