机器人PK传统手术,【柳叶刀】公布两者的治癌功效
2016/08/01
随着科技的发展,机器人逐渐在各个领域展现出了神奇的功效。近年来,机器人手术已经成为前列腺癌常见的治疗手段,那么机器人手术和传统手术的治癌效果有何差异?机器人是否会更胜一筹?7月26日,柳叶刀对此进行了比较。


近年来,机器人手术在医疗领域越来越受欢迎,今年5月22日,在北京和睦家医院,达芬奇机器人为一名45岁的女性胰腺癌患者进行了一项复杂的胰头肿瘤切除术。机器人手术和传统手术对癌症的治疗到底有何差异?机器人是否会更胜一筹?7月26日,柳叶刀比较了机器人手术和开放性手术对癌症患者的治疗效果,结果发现接受这两种手术的患者在三个月后各项关键指标均无明显差异。

机器人手术,越来越普遍

2000年机器人辅助腹腔镜前列腺切除术(RALP)首次被报道,目前前列腺癌患者已有专门的机器人快速手术通道。长期以来,手术一直是治疗局部性前列腺癌的主要方法,近年来大多数临床医生都比较积极地向患者推荐机器人手术,他们认为机器人手术可以给患者带来更高的生活质量和更好的肿瘤预后。

在美国,大约80%-85%的前列腺切除术是由机器人完成,尽管在英国和欧洲这个比例会低些,但它一直在增长。机器人辅助手术是前列腺切除术中最常见的类型,但也越来越多地被应用到心胸外科、妇科、头颈部、一般外科以及泌尿系统的手术中。

机器人辅助腹腔镜前列腺切除术涉及到一个高放大率(X10)的3D摄像头,它可以让医生通过锁孔切口来看清患者的腹腔。机器人共有四只手臂,其中一只与摄像头链接,另外三只与手术过程中所需的其他器械衔接。手术时,外科医生虽然在现场,但并不与患者直接接触,而是通过掌控机器人的手臂来操纵手术。

机器人手术通常比开放性手术的费用会更高些,因为机器人的初始成本大约为150万英镑。到目前为止,还未有随机试验对机器人和开放性手术的治疗结果进行比较。

柳叶刀首次比较机器人和传统手术的癌症治疗效果

机器人手术和传统手术的癌症治疗结果有何差异?为了探索该问题,澳大利亚昆士兰大学临床研究中心的罗伯特教授引领团队开展了随机对照试验。他说,“在12周的随访中,接受机器人手术和开放性手术的患者在生活质量上无统计学差异,其中包括癌症生存率。”不过他还强调,“患者应该选择一个有经验的且自己信任的外科医生,而不是完全依赖于一种特殊的手术方式。”

在该研究中,共有308名前列腺癌患者参与,他们被随机分配到机器人辅助手术组或开放性手术组(耻骨后前列腺根治切除术),人数分别为157和151。患者在手术后均接受了为期12周的随访,所有的手术均由皇家布里斯班妇女医院的两名外科医生引导。

研究人员主要考察的指标为手术后患者的排尿和性功能,结果发现两组患者的这两项指标在手术后均无明显差异,术后并发症的数量也无显著差异。接受开放性手术的患者住院时间较长,但两组患者从术后到再次工作所需的时间相同。

与机器人手术相比,接受开放性手术的患者血液损失要多三倍,不过损失的血液会再循环到患者体内,因此手术过程无需输血。在手术之后,接受机器人手术的患者在1周后经历的痛苦要少一些,在6周后有更好的身体质量,但随着时间的推移,两组的差异变得越来越小,12周后差异开始变得不显著。

不过这只是初步结果,因为整个试验周期为2年。本文通过3个月的随访表明接受两种手术的患者在生活质量上无显著差异,但仍需要长期的随访才能对此充分评估,应充分考虑两种手术给癌症患者带来的生存效益。作者指出,“在手术3年后,患者的泌尿系统和性功能将持续改善,因此两种手术的治疗效益差异可能会变得明显,这篇文章只是这项研究的初级结果,更多的结论要等到试验结束才能得出。”

备注:本文根据MedicalXpress网站编译

原文链接:

First trial of robotic vs. non-robotic surgery for prostate cancer finds both achieve similar outcome at 3 months

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  • Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study

    Background The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology. We aimed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks. Method In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women's Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patient's condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976. Findings Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. 121 assigned to radical retropubic prostatectomy completed the 12 week questionnaire versus 131 assigned to robot-assisted laparoscopic prostatectomy. Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (74·50 vs 71·10; p=0·09) or 12 weeks post-surgery (83·80 vs 82·50; p=0·48). Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (30·70 vs 32·70; p=0·45) or 12 weeks post-surgery (35·00 vs 38·90; p=0·18). Equivalence testing on the difference between the proportion of positive surgical margins between the two groups (15 [10%] in the radical retropubic prostatectomy group vs 23 [15%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a Δ of 10%. However, a superiority test showed that the two proportions were not significantly different (p=0·21). 14 patients (9%) in the radical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0·052). 12 (8%) men receiving radical retropubic prostatectomy and three (2%) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events. Interpretation These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach.

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