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腹腔镜及机器人辅助与开放根治性前列腺切除术治疗局限性前列腺癌的比较

Laparoscopic and robotic-assisted versus open radical prostatectomy for the treatment of localised prostate cancer.

作者信息

Ilic Dragan, Evans Sue M, Allan Christie Ann, Jung Jae Hung, Murphy Declan, Frydenberg Mark

机构信息

Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, The Alfred Centre, Level 6, 99 Commercial Rd, Melbourne, Victoria, Australia, 3004.

出版信息

Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD009625. doi: 10.1002/14651858.CD009625.pub2.

Abstract

BACKGROUND

Prostate cancer is commonly diagnosed in men worldwide. Surgery, in the form of radical prostatectomy, is one of the main forms of treatment for men with localised prostate cancer. Prostatectomy has traditionally been performed as open surgery, typically via a retropubic approach. The advent of laparoscopic approaches, including robotic-assisted, provides a minimally invasive alternative to open radical prostatectomy (ORP).

OBJECTIVES

To assess the effects of laparoscopic radical prostatectomy or robotic-assisted radical prostatectomy compared to open radical prostatectomy in men with localised prostate cancer.

SEARCH METHODS

We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE) and abstract proceedings with no restrictions on the language of publication or publication status, up until 9 June 2017. We also searched bibliographies of included studies and conference proceedings.

SELECTION CRITERIA

We included all randomised controlled trials (RCTs) with a direct comparison of laparoscopic radical prostatectomy (LRP) and robotic-assisted radical prostatectomy (RARP) to ORP, including pseudo-RCTs.

DATA COLLECTION AND ANALYSIS

Two review authors independently classified studies and abstracted data. The primary outcomes were prostate cancer-specific survival, urinary quality of life and sexual quality of life. Secondary outcomes were biochemical recurrence-free survival, overall survival, overall surgical complications, serious postoperative surgical complications, postoperative pain, hospital stay and blood transfusions. We performed statistical analyses using a random-effects model and assessed the quality of the evidence according to GRADE.

MAIN RESULTS

We included two unique studies with 446 randomised participants with clinically localised prostate cancer. The mean age, prostate volume, and prostate-specific antigen (PSA) of the participants were 61.3 years, 49.78 mL, and 7.09 ng/mL, respectively. Primary outcomes We found no study that addressed the outcome of prostate cancer-specific survival. Based on data from one trial, RARP likely results in little to no difference in urinary quality of life (MD -1.30, 95% CI -4.65 to 2.05) and sexual quality of life (MD 3.90, 95% CI -1.84 to 9.64). We rated the quality of evidence as moderate for both quality of life outcomes, downgrading for study limitations. Secondary outcomes We found no study that addressed the outcomes of biochemical recurrence-free survival or overall survival.Based on one trial, RARP may result in little to no difference in overall surgical complications (RR 0.41, 95% CI 0.16 to 1.04) or serious postoperative complications (RR 0.16, 95% CI 0.02 to 1.32). We rated the quality of evidence as low for both surgical complications, downgrading for study limitations and imprecision.Based on two studies, LRP or RARP may result in a small, possibly unimportant improvement in postoperative pain at one day (MD -1.05, 95% CI -1.42 to -0.68 ) and up to one week (MD -0.78, 95% CI -1.40 to -0.17). We rated the quality of evidence for both time-points as low, downgrading for study limitations and imprecision. Based on one study, RARP likely results in little to no difference in postoperative pain at 12 weeks (MD 0.01, 95% CI -0.32 to 0.34). We rated the quality of evidence as moderate, downgrading for study limitations.Based on one study, RARP likely reduces the length of hospital stay (MD -1.72, 95% CI -2.19 to -1.25). We rated the quality of evidence as moderate, downgrading for study limitations.Based on two study, LRP or RARP may reduce the frequency of blood transfusions (RR 0.24, 95% CI 0.12 to 0.46). Assuming a baseline risk for a blood transfusion to be 8.9%, LRP or RARP would result in 68 fewer blood transfusions per 1000 men (95% CI 78 fewer to 48 fewer). We rated the quality of evidence as low, downgrading for study limitations and indirectness.We were unable to perform any of the prespecified secondary analyses based on the available evidence. All available outcome data were short-term and we were unable to account for surgeon volume or experience.

AUTHORS' CONCLUSIONS: There is no high-quality evidence to inform the comparative effectiveness of LRP or RARP compared to ORP for oncological outcomes. Urinary and sexual quality of life-related outcomes appear similar.Overall and serious postoperative complication rates appear similar. The difference in postoperative pain may be minimal. Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions. All available outcome data were short-term, and this study was unable to account for surgeon volume or experience.

摘要

背景

前列腺癌在全球男性中普遍被诊断出来。手术,即根治性前列腺切除术,是局限性前列腺癌男性的主要治疗方式之一。传统上,前列腺切除术是通过开放手术进行的,通常采用耻骨后途径。包括机器人辅助在内的腹腔镜手术方法的出现,为开放性根治性前列腺切除术(ORP)提供了一种微创替代方案。

目的

评估与开放性根治性前列腺切除术相比,腹腔镜根治性前列腺切除术或机器人辅助根治性前列腺切除术对局限性前列腺癌男性的影响。

检索方法

我们使用多个数据库(CENTRAL、MEDLINE、EMBASE)以及摘要会议记录进行了全面检索,对出版语言或出版状态没有限制,截至2017年6月9日。我们还检索了纳入研究的参考文献和会议记录。

选择标准

我们纳入了所有直接比较腹腔镜根治性前列腺切除术(LRP)和机器人辅助根治性前列腺切除术(RARP)与ORP的随机对照试验(RCT),包括准RCT。

数据收集与分析

两位综述作者独立对研究进行分类并提取数据。主要结局是前列腺癌特异性生存、尿生活质量和性生活质量。次要结局是无生化复发生存、总生存、总体手术并发症、术后严重手术并发症、术后疼痛、住院时间和输血情况。我们使用随机效应模型进行统计分析,并根据GRADE评估证据质量。

主要结果

我们纳入了两项独特的研究,共有446名患有临床局限性前列腺癌的随机参与者。参与者的平均年龄、前列腺体积和前列腺特异性抗原(PSA)分别为61.3岁、49.78 mL和7.09 ng/mL。主要结局我们未找到涉及前列腺癌特异性生存结局的研究。基于一项试验的数据,RARP在尿生活质量(MD -1.30,95%CI -4.65至2.05)和性生活质量(MD 3.90,95%CI -1.84至9.64)方面可能几乎没有差异。我们将这两个生活质量结局的证据质量评为中等,因研究局限性而降级。次要结局我们未找到涉及无生化复发生存或总生存结局的研究。基于一项试验,RARP在总体手术并发症(RR 0.41,95%CI 0.16至1.04)或术后严重并发症(RR 0.16,95%CI 0.02至1.32)方面可能几乎没有差异。我们将这两个手术并发症的证据质量评为低,因研究局限性和不精确性而降级。基于两项研究,LRP或RARP可能在术后1天(MD -1.05,95%CI -1.42至 -0.68)和长达1周(MD -0.78,95%CI -1.40至 -0.17)的术后疼痛方面有小幅、可能不太重要的改善。我们将这两个时间点的证据质量都评为低,因研究局限性和不精确性而降级。基于一项研究,RARP在术后12周的术后疼痛方面可能几乎没有差异(MD 0.01,95%CI -0.32至0.34)。我们将证据质量评为中等,因研究局限性而降级。基于一项研究,RARP可能会缩短住院时间(MD -1.72,95%CI -2.19至 -1.25)。我们将证据质量评为中等,因研究局限性而降级。基于两项研究,LRP或RARP可能会降低输血频率(RR 0.24,95%CI 0.12至0.46)。假设输血的基线风险为8.9%,LRP或RARP每1000名男性中将减少68次输血(95%CI减少78次至减少48次)。我们将证据质量评为低,因研究局限性和间接性而降级。我们无法根据现有证据进行任何预先设定的次要分析。所有可用的结局数据都是短期的,我们无法考虑外科医生的手术量或经验。

作者结论

没有高质量证据可用于说明与ORP相比,LRP或RARP在肿瘤学结局方面的比较有效性。与尿和性生活质量相关的结局似乎相似。总体和术后严重并发症发生率似乎相似。术后疼痛的差异可能很小。接受LRP或RARP的男性可能住院时间更短且输血次数更少。所有可用的结局数据都是短期的,并且本研究无法考虑外科医生的手术量或经验。

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