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前列腺特异性抗原水平和前列腺体积作为光选择性汽化前列腺切除术疗效预测指标的影响:一项正在进行的前瞻性多中心3年研究的分析与结果

Impact of prostate-specific antigen level and prostate volume as predictors of efficacy in photoselective vaporization prostatectomy: analysis and results of an ongoing prospective multicentre study at 3 years.

作者信息

Te Alexis E, Malloy Terrence R, Stein Barry S, Ulchaker James C, Nseyo Unyime O, Hai Mahmood A

机构信息

Brady Prostate Center, Department of Urology, Weill Medical College of Cornell University and New York, NY 10021, USA.

出版信息

BJU Int. 2006 Jun;97(6):1229-33. doi: 10.1111/j.1464-410X.2006.06197.x.

Abstract

UNLABELLED

In a multicentre study from the USA, 3-year results of the high-power KTP laser prostatectomy are presented. The authors used preoperative PSA level as a marker of prostate volume and assessed its potential predictive value on the level of clinical efficacy for treating symptomatic BPH. They found that the overall results from the technique were positive and durable, and suggested that there was a significant difference in efficacy between patients presenting with a total PSA of <6 or >6 ng/mL. Many patients who have had a radical prostatectomy are followed for a prolonged period and several observations are presented from an Italian study of urinary incontinence. The authors present their detailed results, finding a considerable trend in incontinence and anastomotic stricture, which decreased over time.

OBJECTIVE

To report the 3-year results and analyse whether total prostate-specific antigen (tPSA) levels and prostate volume before treatment can predict the level of clinical efficacy of photoselective vaporization prostatectomy (PVP) for treating obstructive benign prostatic disease, as high-power potassium-titanyl-phosphate (KTP) laser prostatectomy was previously shown to be safe and to efficiently vaporize prostatic adenoma secondary to benign prostatic hyperplasia (BPH), with minimal bleeding and morbidity.

PATIENTS AND METHODS

From October 2001 to January 2003, 139 men (mean age 67.7 years, sd 8.7) diagnosed with obstructive lower urinary tract symptoms secondary to BPH, had PVP with an average 80 W of KTP laser energy, at six investigational centres. A subanalysis evaluating each patient for tPSA and prostate volume before PVP was conducted, with a long-term assessment of the primary efficacy outcomes at 3 years after PVP. Each patient was assigned to one of two subgroups according to the tPSA level (group 1, < or = 6.0 ng/mL; group 2 > or = 6.1 ng/mL) and evaluated separately. Each subgroup was assessed for changes from baseline in American Urological Symptom Index (AUA SI) score, quality of life (QoL) score, peak urinary flow rate (Q(max)), prostate volume, and postvoid residual urine volume (PVR) at 1, 2 and 3 years after PVP.

RESULTS

All tPSA subgroups had a sustained improvement in all efficacy outcomes maintained through the 3 years. There was a statistically significant difference in the level of improvement between groups 1 and 2 (P < 0.05) in AUA SI and Q(max) at 1, 2 and 3 years. The mean (sd) prostate volume for group 1 was 48.3 (16.7) mL (87 men), and was 83.1 (30.6) mL (52 men) in group 2. The mean percentage improvement in the AUA SI at 1, 2 and 3 years in group 1 and 2, respectively, was 86%, 92% and 85%, and 69%, 74% and 76%; the corresponding percentage improvement in Q(max) was 194%, 185% and 179%, and 124%, 145% and 139%, respectively. Overall treatment efficacy in all patients evaluated showed a mean 83%, 79%, 71% and 165% improvement in AUA SI, QoL, PVR and Q(max), respectively. Adverse events were minimal and the re-treatment rate was 4.3%.

CONCLUSIONS

These results suggest that there is a significant difference in efficacy in patients with a tPSA of < or = 6.0 ng/mL or > or = 6.1 ng/mL before PVP. However, the overall results achieved with PVP were very positive and durable to 3 years, irrespective of tPSA level and prostate volume.

摘要

未标注

在美国的一项多中心研究中,公布了高功率KTP激光前列腺切除术的3年结果。作者将术前前列腺特异性抗原(PSA)水平用作前列腺体积的标志物,并评估其对治疗有症状良性前列腺增生(BPH)临床疗效水平的潜在预测价值。他们发现该技术的总体结果是积极且持久的,并表明总PSA<6或>6 ng/mL的患者在疗效上存在显著差异。许多接受根治性前列腺切除术的患者被长期随访,并且呈现了一项来自意大利关于尿失禁研究的若干观察结果。作者展示了他们的详细结果,发现尿失禁和吻合口狭窄有相当大的趋势,且随时间推移而减少。

目的

报告3年结果,并分析治疗前总前列腺特异性抗原(tPSA)水平和前列腺体积是否能够预测光选择性汽化前列腺切除术(PVP)治疗梗阻性良性前列腺疾病的临床疗效水平,因为先前已表明高功率磷酸钛钾(KTP)激光前列腺切除术是安全的,并且能够有效汽化继发于良性前列腺增生(BPH)的前列腺腺瘤,出血和发病率极低。

患者与方法

从2001年10月至2003年1月,139名被诊断为继发于BPH的梗阻性下尿路症状的男性,在6个研究中心接受了平均80 W KTP激光能量的PVP治疗。对每位患者在PVP治疗前进行tPSA和前列腺体积的亚组分析,并在PVP治疗3年后对主要疗效结局进行长期评估。根据tPSA水平将每位患者分配到两个亚组之一(第1组,≤6.0 ng/mL;第2组,≥6.1 ng/mL)并分别进行评估。在PVP治疗后1年、2年和3年,对每个亚组的美国泌尿外科学会症状指数(AUA SI)评分、生活质量(QoL)评分、最大尿流率(Q(max))、前列腺体积和残余尿量(PVR)相对于基线的变化进行评估。

结果

所有tPSA亚组在所有疗效结局方面均持续改善,持续3年。在1年、2年和3年时,第1组和第2组在AUA SI和Q(max)的改善水平上存在统计学显著差异(P<0.05)。第1组的平均(标准差)前列腺体积为48.3(16.7)mL(87名男性),第2组为83.1(30.6)mL(52名男性)。第1组和第2组在1年、2年和3年时AUA SI的平均改善百分比分别为86%、92%和85%,以及69%~74%和76%;Q(max)的相应改善百分比分别为194%、185%和179%,以及124%、145%和139%。在所有评估患者中,总体治疗疗效显示AUA SI、QoL、PVR和Q(max)分别平均改善83%、79%、71%和165%。不良事件极少,再次治疗率为4.3%。

结论

这些结果表明,PVP治疗前tPSA≤6.0 ng/mL或≥6.1 ng/mL的患者在疗效上存在显著差异。然而,无论tPSA水平和前列腺体积如何,PVP所取得的总体结果非常积极且可持续至3年。

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