前列腺健康指数在中国男性前列腺癌诊断中的应用研究

Use of prostate health index in diagnosing prostate cancer in Chinese men

目的 探讨前列腺健康指数（PHI）在总前列腺特异抗原（tPSA） ＜20 μg/L患者前列腺癌诊断中的价值.方法 对2013年3月至2016年4月复旦大学附属肿瘤医院泌尿外科收治的1135例tPSA＜20 μg/L且符合前列腺穿刺指征的患者进行前瞻性研究.检测血清tPSA、游离前列腺特异抗原和前列腺特异抗原同源异构体2,并计算PHI;使用受试者工作特征（ROC）曲线分析PHI和tPSA的诊断效能;计算不同PHI的患者前列腺癌的检出率.对716例年龄≥50岁,tPSA为4～10 μg/L且直肠指检阴性的研究对象进行亚组分析.组间比较采用Mann-Whitney U检验.通过ROC曲线分析PHI与前列腺癌的相关性和预测效力,曲线下面积（AUC）用Delong·Clarke-Pearson检验进行比较.结果 在tPSA＜ 20 μg/L的研究对象中,前列腺癌患者的PHI高于非前列腺癌患者[48.4（37.4）比26.5（16.9）,U=52 674.00,P=0.000],高级别前列腺癌患者的PHI高于低级别前列腺癌患者[56.4（42.5）比44.5（30.8）,U=23 314.00,P=0.000].PHI诊断前列腺癌的AUC高于tPSA（0.771比0.627,P=0.000）.PHI为＜27、27～ ＜36、36～ ＜55和≥55时,患者罹患前列腺癌的概率分别为9.4％ （95％CI：7.0％ ～ 12.2％）、16.3％ （95％ CI：12.2％～ 20.8％）、31.0％ （95％ CI：25.9％ ～37.3％）和66.4％（95％CI：58.9％～74.2％）.亚组分析的研究对象中,PHI诊断前列腺癌的AUC高于tPSA（0.764比0.569,P=0.000）;PHI为＜27、27～＜36、36～ ＜55和≥55时,患者罹患前列腺癌的概率分别为8.1％（95％CI：5.4％～ 11.3％）、14.0％ （95％ CI：9.1％ ～ 19.9％）、30.8％（95％ CI：23.6％～38.7％）和78.8％ （95％CI：66.7％～88.9％）.结论 在tPSA＜20 μg/L的中国男性中,PHI诊断前列腺癌的效能优于tPSA.

Objective To investigate the value of prostate health index （PHI） in the diagnosis of prostate cancer in patients with total prostate specific antigen （tPSA） 〈 20 μg/L.Methods Totally 1 135 patients with tPSA 〈 20 μg/L and prostate biopsy indications at Department of Urology,Fudan University Shanghai Cancer Center from March 2013 to April 2016 were enrolled in this study.They were tested for serum tPSA,free prostate specific antigen and prostate specific antigen isoform 2,from which PHI was calculated.Diagnostic efficacy of PHI and tPSA were evaluated using receiver operating characteristic （ROC） curve analysis.The detection rates of prostate cancer were calculated in different ranges of PHI.Subgroup analysis of 716 patients,who were aged 50 or above with tPSA in the range of 4 to 10 μg/L and digital rectal examination negative,was performed.Results In the biopsied objects with tPSA〈20 μg/L,PHI was significantly higher in prostate cancer patients than that in non-cancer patients （48.4 （37.4） vs.26.5 （16.9）,U=52 674.00,P =0.000）,PHI was also significantly higher in high-grade prostate cancer patients than that of low-grade prostate cancer patients （44.5 （30.8） vs.56.4（42.5）,U=23 314.00,P=0.000）.The area under the curve （AUC） of PHI for diagnosing prostate cancer was significantly higher than that of tPSA （0.771 vs.0.627,P=0.000）.When PHI was in the range of 〈27,27 to 〈36,36 to 〈55 and ≥55,the probability of prostate cancer was 9.4% （95%CI：7.0% to 12.2%）,16.3% （95%CI：12.2% to 20.8%）,31.0% （95%CI：25.9% to 37.3%） and 66.4% （95%CI：58.9% to 74.2%）,respectively.Subgroup analysis showed that the AUC of PHI in diagnosing prostate cancer was significantly higher than that of tPSA （0.764 vs.0.569,P=0.000）.When PHI was in the range of 〈27,27 to 〈36,36 to 〈55 and ≥55,the probability of prostate cancer was 8.1% （95%CI：5.4% to 11.3%）,14.0%（95%CI：9.1% to 19.9%）,30.8% （95%CI：23.6% to 38.7%） and 78.8% （95%CI：66.7% to 88.9%）,respectively.Conclusion PHI is superior to tPSA in the diagnosis of prostate cancer in Chinese men with tPSA〈20 μg/L.