癌症和无复发生存期的主要腹部手术的围手术期硬膜外镇痛：随机试验。

Perioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: randomised trial.

机构信息

Department of Anaesthesia and Perioperative Medicine, Alfred Hospital, Melbourne, Australia.

出版信息

BMJ. 2011 Mar 29;342:d1491. doi: 10.1136/bmj.d1491.

DOI:10.1136/bmj.d1491

PMID:21447587

Abstract

OBJECTIVE

To compare long term recurrence of cancer and survival of patients having major abdominal surgery for cancer.

DESIGN

Long term follow-up of prospective randomised controlled clinical trial in which patients were randomly assigned to receive general anaesthesia with or without epidural block for at least three postoperative days. Setting 23 hospitals in Australia, New Zealand, and Asia.

PARTICIPANTS

503 adult patients who had potentially curative surgery for cancer.

MAIN OUTCOME MEASURE

Cancer-free survival (analysis was by intention to treat).

RESULTS

Long term follow-up data were available for 94% (n=446) of eligible participants. The median time to recurrence of cancer or death was 2.8 (95% confidence interval 0.7 to 8.7) years in the control group and 2.6 (0.7 to 8.7) years in the epidural group (P=0.61). Recurrence-free survival was similar in both epidural and control groups (hazard ratio 0.95, 95% confidence interval 0.76 to 1.17; P=0.61).

CONCLUSION

Use of epidural block in abdominal surgery for cancer is not associated with improved cancer-free survival.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ACTRN12607000637448.

摘要

目的

比较接受腹部大手术治疗癌症的患者癌症复发和生存的长期情况。

设计

对前瞻性随机对照临床试验进行长期随访，患者被随机分配接受全身麻醉加或不加硬膜外阻滞至少 3 天的术后治疗。

地点

澳大利亚、新西兰和亚洲的 23 家医院。

对象

503 例接受可能治愈性手术的成年癌症患者。

主要观察指标

无癌生存（分析采用意向治疗）。

结果

94%（n=446）合格参与者可获得长期随访数据。对照组癌症复发或死亡的中位时间为 2.8 年（95%可信区间 0.7 至 8.7 年），硬膜外组为 2.6 年（0.7 至 8.7 年）（P=0.61）。两组硬膜外和对照组的无复发生存率相似（危险比 0.95，95%可信区间 0.76 至 1.17；P=0.61）。