Leitão Tito Palmela, Alfarelos Joana, Rodrigues Teresa, Pereira E Silva Ricardo, Garcia Rodrigo Miguel, Martinho David, Sandul Anatoliy, Mendonça Tiago, Pereira Sérgio, Lopes Tomé Matos
Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Faculdade de Medicina da Universidade de Lisboa (FMUL), Centro Académico de Medicina de Lisboa (CAML), Lisboa, Portugal.
Urology Department, Centro Hospitalar Lisboa Norte (CHLN), Lisboa, Portugal.
Clin Genitourin Cancer. 2017 Feb;15(1):117-121. doi: 10.1016/j.clgc.2016.06.003. Epub 2016 Jun 23.
We evaluated whether the Vienna nomogram increases the detection rate of transrectal ultrasound-guided prostate biopsy compared with a 10-core biopsy protocol.
In the present prospective randomized study, men eligible for prostate biopsy were randomized to a Vienna nomogram protocol (group A) or a 10-core protocol (group B). They were further stratified according to age (≤ 65, > 65 but ≤ 70, and > 70 years) and prostate volume (≤ 30, > 30 but ≤ 50, > 50 but ≤ 70, and > 70 cm). The cancer detection rate (CDR) was compared between the groups by logistic regression analysis, with adjustment for age as necessary, overall and with age and prostate volume stratification. Additional statistical analysis was performed with Fisher's exact test for contingency tables and the Mann-Whitney U test for 2 independent samples. P < .05 was considered statistically significant. A subgroup analysis was performed for patients with serum prostate-specific antigen levels of 2 to 10 ng/mL.
From January 2009 to July 2010, 456 patients were enrolled, 237 to the Vienna nomogram group and 219 to the 10-core group. No significant differences were found in serum prostate-specific antigen or prostate volume between the 2 groups. Multivariate analysis with adjustment for age revealed no significant differences in CDR, with 42.6% in group A and 38.4% in group B (P = .705). When stratified by age and prostate volume, no statistically significant differences were found in the CDR between the groups in all subclasses. Also, in the subgroup analysis, CDR was not significantly different, 37.9% versus 34.7% for groups A and B, respectively (P = .891).
These results study suggest that the use of the Vienna nomogram does not significantly increase the overall CDR compared with a 10-core biopsy scheme. Further prospective randomized studies, with adequate sample sizes, are needed to definitively determine the best prostate biopsy protocol.
我们评估了相对于10针活检方案，维也纳列线图是否能提高经直肠超声引导下前列腺穿刺活检的检出率。
在本前瞻性随机研究中，符合前列腺穿刺活检条件的男性被随机分为维也纳列线图方案组（A组）或10针方案组（B组）。他们进一步根据年龄（≤65岁、>65岁但≤70岁以及>70岁）和前列腺体积（≤30cm、>30cm但≤50cm、>50cm但≤70cm以及>70cm）进行分层。通过逻辑回归分析比较两组之间的癌症检出率（CDR），必要时对年龄进行调整，包括总体以及按年龄和前列腺体积分层的情况。还使用了针对列联表的Fisher精确检验和针对两个独立样本的Mann-Whitney U检验进行额外的统计分析。P <.05被认为具有统计学意义。对血清前列腺特异性抗原水平为2至10 ng/mL的患者进行了亚组分析。
从2009年1月至2010年7月，共纳入456例患者，237例进入维也纳列线图组，219例进入10针组。两组之间在血清前列腺特异性抗原或前列腺体积方面未发现显著差异。对年龄进行调整的多变量分析显示CDR无显著差异，A组为42.6%，B组为38.4%（P = 0.705）。按年龄和前列腺体积分层时，所有亚组中两组之间的CDR均未发现统计学上的显著差异。此外，在亚组分析中，CDR也无显著差异，A组和B组分别为37.9%和34.7%（P = 0.891）。
这些结果表明，与10针活检方案相比，使用维也纳列线图并不能显著提高总体CDR。需要进行进一步的前瞻性随机研究，且样本量要足够，以最终确定最佳的前列腺活检方案。
