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腹腔镜和机器人辅助与开放性根治性前列腺切除术治疗局限性前列腺癌:一项 Cochrane 系统评价。

Laparoscopic and robot-assisted vs open radical prostatectomy for the treatment of localized prostate cancer: a Cochrane systematic review.

机构信息

Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic., Australia.

Centre of Research Excellence in Patient Safety, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic., Australia.

出版信息

BJU Int. 2018 Jun;121(6):845-853. doi: 10.1111/bju.14062. Epub 2017 Nov 17.

DOI:10.1111/bju.14062
PMID:29063728
Abstract

OBJECTIVE

To determine the effects of laparoscopic radical prostatectomy (LRP), or robot-assisted radical prostatectomy (RARP) compared with open radical prostatectomy (ORP) in men with localized prostate cancer.

MATERIALS AND 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 included all randomized or pseudo-randomized controlled trials that directly compared LRP and RARP with ORP. Two review authors independently examined full-text reports, identified relevant studies, assessed the eligibility of studies for inclusion, extracted data and assessed risk of bias. We performed statistical analyses using a random-effects model and assessed the quality of the evidence according to Grading of Recommendations Assessment, Development and Evaluation (GRADE). 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.

RESULTS

We included two unique studies in a total of 446 randomized participants with clinically localized prostate cancer. All available outcome data were short-term (up to 3 months). We found no study that addressed the outcome of prostate cancer-specific survival. Based on one trial, RARP probably results in little to no difference in urinary quality of life (mean difference [MD] -1.30, 95% confidence interval [CI] -4.65 to 2.05; moderate quality of evidence) and sexual quality of life (MD 3.90, 95% CI: -1.84 to 9.64; moderate quality of evidence). No study 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 (risk ratio [RR] 0.41, 95% CI: 0.16-1.04; low quality of evidence) or serious postoperative complications (RR 0.16, 95% CI: 0.02-1.32; low quality of evidence). Based on two studies, LRP or RARP may result in a small, possibly unimportant improvement in postoperative pain at 1 day (MD -1.05, 95% CI: -1.42 to -0.68; low quality of evidence) and up to 1 week (MD -0.78, 95% CI: -1.40 to -0.17; low quality of evidence). Based on one study, RARP probably results in little to no difference in postoperative pain at 12 weeks (MD 0.01, 95% CI: -0.32 to 0.34; moderate quality of evidence). Based on one study, RARP probably reduces the length of hospital stay (MD -1.72, 95% CI: -2.19 to -1.25; moderate quality of evidence). Based on two studies, LRP or RARP may reduce the frequency of blood transfusions (RR 0.24, 95% CI: 0.12-0.46; low quality of evidence). Assuming a baseline risk for a blood transfusion to be 8.9%, LRP or RARP would result in 68 fewer blood transfusions per 1,000 men (95% CI: 78-48 fewer).

CONCLUSIONS

There is no evidence to inform the comparative effectiveness of LRP or RARP compared with ORP for oncological outcomes. Urinary and sexual quality of life 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.

摘要

目的

确定与开放性前列腺切除术(ORP)相比,腹腔镜前列腺切除术(LRP)或机器人辅助前列腺切除术(RARP)在局限性前列腺癌患者中的疗效。

材料与方法

我们使用多个数据库(CENTRAL、MEDLINE、EMBASE)和摘要会议进行了全面检索,对发表语言或发表状态没有任何限制,检索截至 2017 年 6 月 9 日。我们纳入了所有直接比较 LRP 和 RARP 与 ORP 的随机或半随机对照试验。两名综述作者独立检查全文报告,确定相关研究,评估研究纳入的资格,提取数据并评估偏倚风险。我们使用随机效应模型进行统计分析,并根据推荐评估、制定与评价(GRADE)对证据质量进行评估。主要结局为前列腺癌特异性生存、尿质量和性功能质量。次要结局为生化无复发生存、总生存、总手术并发症、严重术后手术并发症、术后疼痛、住院时间和输血。

结果

我们共纳入了两项独特的研究,共纳入了 446 名患有局限性前列腺癌的随机参与者。所有可用的短期结局数据(最长 3 个月)均提示:与 ORP 相比,LRP 或 RARP 对前列腺癌特异性生存无显著影响;基于一项试验,LRP 或 RARP 对尿质量的影响可能较小(MD-1.30,95%CI-4.65 至 2.05;中质量证据),对性功能质量的影响可能较小(MD3.90,95%CI-1.84 至 9.64;中质量证据);没有研究报告生化无复发生存或总生存的结局;基于一项试验,LRP 或 RARP 对总手术并发症的影响可能较小(RR0.41,95%CI-16-1.04;低质量证据),对严重术后并发症的影响可能较小(RR0.16,95%CI-0.02-1.32;低质量证据);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;低质量证据)和 1 周(MD-0.78,95%CI-1.40 至-0.17;低质量证据)时减轻术后疼痛,差异可能较小;基于一项研究,LRP 或 RARP 对术后 12 周时的疼痛影响可能较小(MD0.01,95%CI-0.32 至 0.34;中质量证据);基于一项研究,LRP 可能会缩短住院时间(MD-1.72,95%CI-2.19 至-1.25;中质量证据);基于两项研究,LRP 或 RARP 可能会减少输血的频率(RR0.24,95%CI-0.12-0.46;低质量证据)。假设输血的基线风险为 8.9%,LRP 或 RARP 每 1000 名男性将减少 68 次输血(95%CI-78 至 48 次)。

结论

尚无证据表明与 ORP 相比,LRP 或 RARP 在肿瘤学结局方面更具优势。尿质量和性功能质量似乎相似。总体和严重术后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较短,输血较少。

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