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中华腔镜泌尿外科杂志(电子版) ›› 2021, Vol. 15 ›› Issue (06) : 478 -483. doi: 10.3877/cma.j.issn.1674-3253.2021.06.007

临床研究

前列腺健康指数及f/tPSA对于PSA"灰区"前列腺癌诊断价值比较的Meta分析
贾伟1, 吴波1, 陈骞1, 张旭辉1, 王东文2,†()   
  1. 1. 030001　太原，山西医科大学第一医院
    2. 518116　深圳，国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院深圳医院泌尿外科
  • 收稿日期:2020-06-09 出版日期:2021-12-01
  • 通信作者: 王东文
  • 基金资助:
    山西省重点研发计划（社会发展领域）(201803D31110); 山西医科大学第一医院创新团队基金(YT1604); 山西省"1331工程"重点创新团队建设计划资助(1331KIRT)

Prostate health index versus free/total PSA for prostate cancer detection in patients with PSA levels in "gray area" : a systematic analysis

Wei Jia1, Bo Wu1, Qian Chen1, Xuhui Zhang1, Dongwen Wang2,†()   

  1. 1. Department of Urology, the First Hospital of Shanxi Medical University, Taiyuan 030001, China
    2. Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen 518116, China
  • Received:2020-06-09 Published:2021-12-01
  • Corresponding author: Dongwen Wang
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引用本文：

贾伟, 吴波, 陈骞, 张旭辉, 王东文. 前列腺健康指数及f/tPSA对于PSA"灰区"前列腺癌诊断价值比较的Meta分析[J]. 中华腔镜泌尿外科杂志(电子版), 2021, 15(06): 478-483.

Wei Jia, Bo Wu, Qian Chen, Xuhui Zhang, Dongwen Wang. Prostate health index versus free/total PSA for prostate cancer detection in patients with PSA levels in "gray area" : a systematic analysis[J]. Chinese Journal of Endourology(Electronic Edition), 2021, 15(06): 478-483.

目的

系统评价前列腺健康指数（PHI）及游离/总前列腺特异性抗原（f/tPSA）对于PSA="灰区"（2~10 ng/ml）前列腺癌诊断价值的比较。

方法

通过检索Pubmed、Cochrane图书馆、Embase、中国学术期刊全文数据库、维普期刊全文数据库5个数据库，收集报告PHI、f/tPSA在PSA"灰区"前列腺癌诊断价值的文献。使用MetaDisc 1.4软件、STATA 11.0进行统计分析。

结果

共12篇文献，4 639例研究对象纳入Meta分析。穿刺诊断前列腺癌患者1 703例，穿刺阴性2 936人。PHI、f/tPSA合并敏感性分别为0.87（95%CI：0.85~0.89）、0.86（95%CI：0.84~0.87）；合并特异性分别为0.42（95%CI：0.40~0.44），0.24（95%CI：0.22~0.25）；ROC曲线下面积PHI：0.803，f/tPSA=0.644（P<0.001）。

结论

PHI较%fPSA在PSA"灰区"前列腺癌诊断中存在明显优势。

关键词: 前列腺健康指数, 前列腺特异性抗原, 前列腺癌, Meta分析
Objective

To investigate the value of prostate health index and free/total PSA(f/tPSA) of prostate cancer detection in patients with PSA levels between 2-10 ng/ml "gray area" .

Methods

Relevant articles in 5 online databases Pubmed, Embase, Cochrane library, CNKI, VIP were enrolled. Systematic analysis was performed by MetaDisc 1.4, STATA 11.0.

Results

12 articles and 4 639 patients were included in present analysis. As a result, a total of 1 703 patients was confirmed prostate cancer, number of patients with negative prostate biopsies was 2 936. The pooled sensitivity of PHI and f/tPSA were 0.87(95%CI:0.85-0.89) vs 0.86(95%CI:0.84-0.87), respectively, the pooled specificity of PHI and %fPSA were 0.42 (95%CI:0.40-0.44) vs 0.24(95%CI:0.22-0.25). The ROC of PHI and f/tPSA were 0.803 vs 0.644 (P<0.001).

Conclusion

PHI has a obvious advantage over the f/tPSA for prostate cancer detection in patients with PSA levels of "gray area" .

Key words: Prostate health index, PSA, Prostate cancer, Meta-analysis
表1 纳入PHI和PSA诊断PCa文献的基本特征及质量评价
文献 研究国家 研究类型 入组标准 人群年龄(岁) 样本数量(例) 前列腺癌患者数量(例) PHI f/tPSA QUADAS得分
PSA(ng/ml) 直肠指诊 年龄(岁) 临界值 AUC 临界值 AUC
Le等[7] 美国 前瞻性 2.5~10 无 - 63 063 26 - 0.77 - 0.68 21
Jasen①等[8] 荷兰 回顾性 2.5~10 有 - 66(55~75) 405 226 - 0.710 - 0.68 23
Jasen②等[8] 奥地利 回顾性 2~10 - ≥50 60(50~77) 351 174 - 0.71 - 0.58 23
Catolona等[9] 美国 前瞻性 2~10 无 ≥50 62.8±7.0 892 430 21.30 0.71 - 0.65 27
Guazzoni等[10] 意大利 前瞻性 2~10 无 - 63.3±8.2 268 107 48.5 0.76 0.29 0.58 27
Ito等[11] 日本 回顾性 2~10 无 - 66(37~82) 239 53 24.9 - 0.23 - 23
Ferro等[12] 意大利 前瞻性 2~10 - ≥50 60(50~73) 300 108 31.6 0.77 0.10 0.62 27
Lazzeri等[13] 意大利/德国/法国/西班牙/英国 前瞻性 2~10 - >40 64.2±7.5 646 264 27.6 0.67 0.22 0.64 26
Ng等[14] 中国 回顾性 4~10 无 >45 65.9(50~79)0 230 21 26.54 0.78 0.28 0.57 23
Tan等[15] 新加坡 前瞻性 4~10 无 50~75 065.4±6.46 157 30 26.75 0.79 0.10 0.42 27
Na等[16] 中国 前瞻性 2~10 - - 66.95±8.89 660 136 31.0 0.87 0.22 0.68 27
Cheng等[17] 中国 前瞻性 4~10 - - 66(61~72) 121 33 21.62 0.77 0.25 0.59 25
Fan等[18] 中国 前瞻性 4~10或<4 DRE（+） - - 66(57.7~74.3) 307 95 35.15 0.78 0.27 0.63 27
表2 PHI值诊断前列腺癌四格表
文献 真阳性例数 假阳性例数 假阴性例数 真阴性例数 敏感性 特异性
Le等[7] 23 13 3 24 0.885 0.649
Jasen①等[8] 203 117 23 62 0.900 0.347
Jasen②等[8] 157 122 17 55 0.900 0.311
Catolona等[9] 387 342 43 120 0.900 0.260
Guazzoni等[10] 46 16 61 145 0.429 0.900
Ito等[11] 48 124 5 62 0.900 0.333
Ferro等[12] 97 115 11 77 0.900 0.400
Lazzeri等[13] 238 308 26 74 0.902 0.194
Ng等[14] 19 105 2 104 0.900 0.498
Tan等[15] 27 53 3 74 0.900 0.583
Na等[16] 122 210 14 314 0.900 0.599
Cheng等[17] 30 64 3 24 0.900 0.273
Fan等[18] 86 113 9 99 0.900 0.467
表3 f/tPSA诊断前列腺癌四格表
文献 真阳性例数 假阳性例数 假阴性例数 真阴性例数 敏感性 特异性
Le等[7] 023 022 03 15 0.885 0.405
Jasen①等[8] 203 139 23 40 0.900 0.222
Jasen②等[8] 157 156 17 21 0.900 0.119
Catolona等[9] 387 379 43 83 0.900 0.180
Guazzoni等[10] 021 016 86 1450 0.200 0.900
Ito等[11] 048 145 05 41 0.900 0.220
Ferro等[12] 097 154 11 38 0.900 0.200
Lazzeri等[13] 239 300 25 82 0.905 0.215
Ng等[14] 019 186 02 23 0.900 0.110
Tan等[15] 027 118 03 09 0.900 0.071
Na等[16] 122 380 14 1440 0.900 0.275
Cheng等[17] 030 071 03 17 0.900 0.193
Fan等[18] 086 177 09 35 0.900 0.167
表4 PHI对于临床有意义前列腺癌诊断表现
生物标志物 研究数量 敏感性(95%置信区间) 特异性(95%置信区间) 诊断比值比(95%置信区间) 阳性似然比(95%置信区间) 阴性似然比(95%置信区间) 曲线下面积（标准误）
PHI 4 0.83 (0.78~0.87) 0.64 (0.62~0.66) 11.80 (5.07~27.45) 2.44 (1.82~3.27) 0.21 (0.10~0.45) 0.82 (0.07)
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