Department of Public Health, University "Federico II", Naples, Italy.
Department of Translational Medical Sciences, University "Federico II", Naples, Italy.
Transl Res. 2014 Dec;164(6):444-51. doi: 10.1016/j.trsl.2014.06.006. Epub 2014 Jun 26.
The most promising approach to improve the specificity of prostate-specific antigen (PSA) test relies on the measurement of different molecular isoforms of PSA in serum. Currently, in men with a total PSA (tPSA) level between 2 and 10 ng/mL, measurement of %fPSA (free to total PSA ratio ×100) is used as reflex testing to better distinguish between malignant and benign prostate disease. Recently, Beckman Coulter developed the prostate health index (PHI) and several studies suggested that this test may improve the diagnostic ability of %fPSA.We performed a meta-analysis to evaluate the usefulness of PHI compared with %fPSA in the detection of prostate cancer (PCa) at first biopsy in men with tPSA "gray" levels of 2-10 ng/mL. Data on sensitivity and specificity were extracted from 8 eligible studies. Only observational studies comparing the diagnostic ability of PHI and %fPSA in tPSA range of 2-10 ng/mL were included. A total of 8 studies involving 2969 patients with a tPSA range of 2-10 ng/mL undergoing first biopsy were included in this meta-analysis. Biopsy-confirmed PCa was detected in 1287 (43.3%) men. Selected studies determined both PHI and %fPSA as a reflex test. The areas under curve (AUCs) of PHI and %fPSA were 0.74 (95% confidence interval [CI], 0.70-0.77) and 0.63 (95% CI, 0.58-0.67), respectively. Meta-regression analysis confirmed the superiority of PHI which showed, compared with %fPSA, a relative diagnostic odds ratio of 2.81 (95% CI, 2.19-3.6; P < 0.0001). In conclusion, PHI instead of %fPSA as a reflex test in men with tPSA "gray" levels is a better predictor of positive first biopsy and can offer a reduction in unnecessary biopsies.
最有前途的提高前列腺特异性抗原（PSA）检测特异性的方法是测量血清中不同的 PSA 分子亚型。目前，在总 PSA（tPSA）水平在 2 到 10ng/mL 之间的男性中，%fPSA（游离 PSA 与总 PSA 比值×100）的测量被用作反射测试，以更好地区分恶性和良性前列腺疾病。最近，贝克曼库尔特公司开发了前列腺健康指数（PHI），几项研究表明，该测试可能提高%fPSA 对前列腺癌（PCa）的诊断能力。我们进行了一项荟萃分析，以评估 PHI 与 %fPSA 在检测 tPSA 为 2-10ng/mL 的男性首次活检中前列腺癌（PCa）的诊断能力。从 8 项符合条件的研究中提取了敏感性和特异性数据。仅纳入比较 PHI 和 %fPSA 在 2-10ng/mL tPSA 范围内诊断能力的观察性研究。本荟萃分析共纳入 8 项研究，涉及 2969 例 tPSA 范围为 2-10ng/mL 的男性，行首次活检。活检证实的 PCa 检出率为 1287 例（43.3%）。选定的研究将 PHI 和 %fPSA 均确定为反射测试。PHI 和 %fPSA 的曲线下面积（AUCs）分别为 0.74（95%置信区间 [CI]，0.70-0.77）和 0.63（95% CI，0.58-0.67）。Meta 回归分析证实了 PHI 的优越性，与 %fPSA 相比，PHI 的相对诊断比值比为 2.81（95% CI，2.19-3.6；P < 0.0001）。总之，在 tPSA“灰色”水平的男性中，PHI 作为反射测试而不是 %fPSA 是首次活检阳性的更好预测因子，并可减少不必要的活检。
