180-W XPS 绿激光汽化术与经尿道前列腺电切术治疗良性前列腺梗阻：一项欧洲多中心随机试验——GOLIATH 研究的 6 个月安全性和疗效结果。

180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study.

机构信息

Department of Urology Basel, University Hospital Basel, University Basel, Basel, Switzerland.

Department of Urology, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.

出版信息

Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.

DOI:10.1016/j.eururo.2013.10.040

PMID:24331152

Abstract

BACKGROUND

The comparative outcome with GreenLight (GL) photoselective vaporisation of the prostate and transurethral resection of the prostate (TURP) in men with lower urinary tract symptoms due to benign prostatic obstruction (BPO) has been questioned.

OBJECTIVE

The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS (XPS) to TURP for International Prostate Symptom Score (IPSS) and maximum flow rate (Qmax) at 6 mo and the proportion of patients who were complication free.

DESIGN, SETTING, AND PARTICIPANTS: Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO.

INTERVENTION

180-W GL XPS system or TURP.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Measurements used were IPSS, Qmax, prostate volume (PV), postvoid residual (PVR) and complications, perioperative parameters, and reintervention rates. Noninferiority was evaluated using one-sided tests at the 2.5% level of significance. The statistical significance of other comparisons was assessed at the (two-sided) 5% level.

RESULTS AND LIMITATIONS

The study demonstrated the noninferiority of XPS to TURP for IPSS, Qmax, and complication-free proportion. PV and PVR were comparable between groups. Time until stable health status, length of catheterisation, and length of hospital stay were superior with XPS (p<0.001). Early reintervention rate within 30 d was three times higher after TURP (p=0.025); however, the overall postoperative reintervention rates were not significantly different between treatment arms. A limitation was the short follow-up.

CONCLUSIONS

XPS was shown to be noninferior (comparable) to TURP in terms of IPSS, Qmax, and proportion of patients free of complications. XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo.

TRIAL REGISTRATION

ClinicalTrials.gov, identifier NCT01218672.

摘要

背景

经尿道前列腺绿激光汽化术（GL）与经尿道前列腺电切术（TURP）治疗因良性前列腺梗阻（BPO）导致下尿路症状的患者的疗效比较一直存在争议。

目的

GOLIATH 研究的主要目的是评估 180W GL XPS（XPS）在国际前列腺症状评分（IPSS）和最大尿流率（Qmax）方面非劣效于 TURP 的疗效，以及无并发症患者的比例。

设计、地点和参与者：在欧洲 9 个国家的 29 个中心进行的前瞻性随机对照试验，纳入 281 例 BPO 患者。

干预

180W GL XPS 系统或 TURP。

测量和统计分析

使用 IPSS、Qmax、前列腺体积（PV）、残余尿量（PVR）和并发症、围手术期参数以及再干预率进行测量。采用单侧检验，以 2.5%的显著性水平评估非劣效性。其他比较的统计显著性评估采用双侧 5%水平。

结果和局限性

研究表明 XPS 在 IPSS、Qmax 和无并发症比例方面非劣效于 TURP。两组之间的 PV 和 PVR 相似。XPS 组在稳定健康状态所需时间、导尿管留置时间和住院时间方面具有优势（p<0.001）。TURP 术后 30d 内早期再干预率高 3 倍（p=0.025）；然而，治疗组之间的总术后再干预率无显著差异。局限性在于随访时间较短。