【探泌】Eur Urol Oncol：在磁共振靶向穿刺活检时代，既往穿刺活检阴性患者是否仍需二次系统穿刺活检？
编者按
为贯彻落实中华医学会泌尿外科学分会“顶天立地”发展规划，加强国内外学术交流，促进我国泌尿外科事业更好更快发展，学习联盟特推出“探泌”栏目。本栏目秉承“专业，公益，共享，共进”原则，旨在传播学科发展资讯，搭建学术交流平台，更好地为我国广大泌尿外科同道服务。
既往系统穿刺活检阴性但仍持续怀疑前列腺癌的患者，在靶向穿刺时是否需附加系统穿刺？发表于《European Urology Oncology》杂志题为《Is There Still a Need for Repeated Systematic Biopsies in Patients with Previous Negative Biopsies in the Era of Magnetic Resonance Imaging-targeted Biopsies of the Prostate?》[1]的文章对系统穿刺和靶向穿刺在临床意义显著前列腺癌、临床意义不显著前列腺癌及整体前列腺癌检出率方面作了对比研究。
【Abstract】
Background: The role of targeted prostate biopsies (TBs) in patients with cancer suspicious lesions on multiparametric magnetic resonance imaging (mpMRI) following negative systematic biopsies (SBs) is undebated. However, whether they should be combined with repeated SBs remains unclear.
背景：对于多参数磁共振成像（mpMRI）疑有前列腺癌，但系统穿刺（SBs）为阴性的患者，靶向穿刺（TBs）的作用毋庸置疑。然而，是否需将靶向穿刺（TBs）与二次系统穿刺（repeated SBs）联合仍不明确。
Objective: To evaluate the value of repeated SBs in addition to TBs in patients with a prior negative SB and a persistent suspicion of prostate cancer (PCa).
目的：评估对既往系统穿刺阴性但仍持续怀疑前列腺癌（PCa）的患者，靶向穿刺附加二次系统穿刺的价值。
Design, setting, and participants: A prospective study as part of a multicenter randomized controlled trial conducted between 2014 and 2017, including 665 men with a prior negative SB and a persistent suspicion of PCa (suspicious digital rectal examination and/or prostate-specific antigen >4.0 ng/ml).
实验设计：该前瞻性研究作为一项在2014-2017年进行的多中心随机对照试验的一部分，共纳入665例既往系统穿刺阴性但仍持续怀疑前列腺癌（直肠指诊可疑和/或PSA>4.0ng / ml）的患者。
Intervention: All patients underwent 3 T mpMRI according to Prostate Imaging Reporting and Data System (PI-RADS) v2. Patients with PI-RADS ≥3 were randomized 1:1:1 for three TB techniques: MRI-TRUS fusion TB (FUS-TB), cognitive registration fusion TB (COG-TB), or in-bore MRI TB. FUS-TB and COG-TB were combined with repeated SBs.
干预：所有患者根据前列腺影像报告和数据系统（PI-RADS）（第二版）接受3T mpMRI。将PI-RADS≥3的患者以1：1：1随机分配三种靶向穿刺技术：MRI-TRUS融合靶向穿刺（FUS-TB）、认知融合靶向穿刺（COG-TB）、磁共振直接引导的靶向穿刺（MRI TB）。其中，FUS-TB和COG-TB联合二次系统穿刺。
Outcome measurements and statistical analysis: Clinically significant prostate cancer (csPCa) was defined as Gleason ≥3 + 4. Differences in detection rates of csPCa, clinically insignificant PCa (cisPCa), and overall PCa between TBs (FUS-TB and COG-TB) and repeated SBs were compared using McNemar's test.
结果评价和数据分析：临床意义显著前列腺癌（csPCa）被定义为Gleason评分≥3 + 4。通过配对卡方检验（McNemar’s test）来评价csPCa、临床意义不显著前列腺癌（cisPCa）和整体前列腺癌（overall PCa）检出率在靶向穿刺（FUS-TB和COG-TB）和二次系统穿刺之间的区别。
Results and limitations: In the 152 patients who underwent both TB and SB, PCa was detected by TB in 47% and by SB in 32% (p < 0.001, 95% confidence interval [CI]: 6.0–22%). TB detected significantly more csPCa than SB (32% vs 16%; p < 0.001, 95% CI: 11–25%). Clinically significant PCa was missed by TB in 1.3% (2/152). Combining SB and TB resulted in detection rate differences of 6.0% for PCa, 5.0% for cisPCa, and 1.0% for csPCa compared with TB alone.
结果和局限性：在同时接受靶向穿刺和系统穿刺的152例患者中，靶向穿刺和系统穿刺对前列腺癌的检出率分别为47％和32％（p＜0.001，95％置信区间：6.0-22%）。靶向穿刺对临床意义显著前列腺癌的检出率显著高于系统穿刺（32％ vs 16％，p＜0.001；95％置信区间：11-25％）。靶向穿刺对临床意义显著前列腺癌的漏诊率为1.3％（2/152）。系统穿刺联合靶向穿刺与单独靶向穿刺对PCa、cisPC、csPCa检出率的差异分别为6.0％、5.0％、1.0％。
Conclusions: In case of a persistent suspicion of PCa following a negative SB, TB detected significantly more csPCa cases than SB. The additional value of SB was limited, and only 1.3% of csPCa would have been missed when SB had been omitted.
结论：对系统穿刺阴性但仍持续怀疑前列腺癌的患者，靶向穿刺对临床意义显著前列腺癌的检出率明显高于系统穿刺。系统穿刺的附加价值是有限的，当省略系统穿刺时，只有1.3％临床意义显著前列腺癌会被漏诊。
译者述评
经直肠超声引导下系统穿刺活检是诊断前列腺癌最常用的手段，但也存在局限性，比如易漏诊临床意义显著前列腺癌(csPCa)、对前列腺尖部或MRI可疑部位难以精准穿刺等，导致漏诊或重复穿刺几率增加，重复穿刺亦增加了疼痛、焦虑和感染等风险。那么，既往系统穿刺活检阴性但仍持续怀疑前列腺癌的患者，在靶向穿刺时是否需附加系统穿刺？
该项研究表明靶向穿刺对临床意义显著前列腺癌的检出率明显高于系统穿刺。仅行靶向穿刺时，临床意义显著前列腺癌的漏诊率仅为1.3%。因此，在二次穿刺时靶向穿刺附加系统穿刺的作用是有限的。
该项研究采用靶向穿刺 vs 靶向穿刺联合系统穿刺，可以做到减少干扰因素及组别差异性，结论更可靠。
【参考文献】
[1] Exterkate L, Wegelin O, Barentsz J O, et al. Is There Still a Need for Repeated Systematic Biopsies in Patients with Previous Negative Biopsies in the Era of Magnetic Resonance Imaging-targeted Biopsies of the Prostate?[J]. European urology oncology, 2019.
编译：徐煜宇（广州医科大学附属第五医院）
编辑：榭小仙
审核：王冬 张栋邦
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