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根治性膀胱切除术治疗膀胱癌患者术后早期恢复的新概念:一项前瞻性随机研究的结果。

A new concept for early recovery after surgery for patients undergoing radical cystectomy for bladder cancer: results of a prospective randomized study.

机构信息

Department of Urology, Ludwig-Maximilians-University, Munich, Germany.

Department of Urology, Ludwig-Maximilians-University, Munich, Germany.

出版信息

J Urol. 2014 Feb;191(2):335-40. doi: 10.1016/j.juro.2013.08.019. Epub 2013 Aug 19.

DOI:10.1016/j.juro.2013.08.019
PMID:23968966
Abstract

PURPOSE

Early recovery after surgery concepts have gained wide acceptance in various surgical specialties. However, limited data are available for radical cystectomy. A new early recovery after surgery concept was compared to a more conservative regimen in patients undergoing radical cystectomy for bladder cancer.

MATERIALS AND METHODS

A total of 101 consecutive patients were prospectively randomized to early recovery after surgery (62) or a conservative regimen (39) (intended randomization ratio was 2 early recovery after surgery-to-1 conservative regimen). Primary end points were differences in quality of life, and secondary end points included postoperative morbidity, demand for analgesics, time spent in the intermediate care unit, mobility and number of gastrointestinal events during hospital stay.

RESULTS

Quality of life parameters, as measured by the EORTC (European Organization for the Research and Treatment of Cancer) Quality of Life questionnaire QLQ-30 did not change significantly between postoperative days 3 and 7 and at discharge from hospital in the conservative regimen group, whereas a significant improvement was observed in the early recovery after surgery group. Postoperative morbidity was lower in the early recovery after surgery group in terms of wound healing disorders (p = 0.006), fever (p = 0.004) and thrombosis (p = 0.027). The demand for analgesics was significantly lower in the early recovery after surgery group. The amount of food consumed in relation to the amount of food offered was significantly higher for the early recovery after surgery group as early as day 3 (p = 0.02). Time spent in the intermediate care unit was significantly shorter for the early recovery after surgery group (p <0.001). There were no significant differences between the groups with respect to gastrointestinal events. The main limitations of this study were the lack of long-term data as well as the single center approach.

CONCLUSIONS

Early recovery after surgery of patients who underwent radical cystectomy appears to have significant benefits compared to a conservative regimen in terms of postoperative morbidity, quality of life, use of analgesics and time spent in the intermediate care unit.

摘要

目的

手术后早期恢复的理念在多个外科专业领域得到了广泛的认可。然而,针对根治性膀胱切除术,相关数据有限。本研究比较了一种新的术后早期恢复理念与更为保守的治疗方案,应用于膀胱癌行根治性膀胱切除术的患者。

材料和方法

共前瞻性连续纳入 101 例患者,随机分为术后早期恢复组(62 例)和保守治疗组(39 例)(预期随机分配比为 2 比 1)。主要终点为生活质量的差异,次要终点包括术后发病率、镇痛药需求、入住中间护理病房的时间、活动能力和住院期间胃肠道事件的发生次数。

结果

保守治疗组患者术后第 3 天和第 7 天以及出院时的 EORTC(欧洲癌症研究与治疗组织)生活质量问卷 QLQ-30 测量的生活质量参数没有显著变化,而早期恢复组则有显著改善。在早期恢复组,伤口愈合障碍(p=0.006)、发热(p=0.004)和血栓形成(p=0.027)的术后发病率较低。早期恢复组对镇痛药的需求显著降低。早期恢复组第 3 天开始,摄入的食物量与提供的食物量的比例显著升高(p=0.02)。早期恢复组入住中间护理病房的时间显著缩短(p<0.001)。两组之间胃肠道事件无显著差异。本研究的主要局限性是缺乏长期数据以及单中心研究方法。

结论

与保守治疗方案相比,根治性膀胱切除术患者术后早期恢复在术后发病率、生活质量、镇痛药使用和入住中间护理病房时间方面具有显著优势。

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