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硬膜外麻醉-肺癌手术后无复发生存率:一项随机试验。

Epidural Anesthesia-Analgesia and Recurrence-free Survival after Lung Cancer Surgery: A Randomized Trial.

出版信息

Anesthesiology. 2021 Sep 1;135(3):419-432. doi: 10.1097/ALN.0000000000003873.

DOI:10.1097/ALN.0000000000003873
PMID:34192298
Abstract

BACKGROUND

Regional anesthesia and analgesia reduce the stress response to surgery and decrease the need for volatile anesthesia and opioids, thereby preserving cancer-specific immune defenses. This study therefore tested the primary hypothesis that combining epidural anesthesia-analgesia with general anesthesia improves recurrence-free survival after lung cancer surgery.

METHODS

Adults scheduled for video-assisted thoracoscopic lung cancer resections were randomized 1:1 to general anesthesia and intravenous opioid analgesia or combined epidural-general anesthesia and epidural analgesia. The primary outcome was recurrence-free survival (time from surgery to the earliest date of recurrence/metastasis or all-cause death). Secondary outcomes included overall survival (time from surgery to all-cause death) and cancer-specific survival (time from surgery to cancer-specific death). Long-term outcome assessors were blinded to treatment.

RESULTS

Between May 2015 and November 2017, 400 patients were enrolled and randomized to general anesthesia alone (n = 200) or combined epidural-general anesthesia (n = 200). All were included in the analysis. The median follow-up duration was 32 months (interquartile range, 24 to 48). Recurrence-free survival was similar in each group, with 54 events (27%) with general anesthesia alone versus 48 events (24%) with combined epidural-general anesthesia (adjusted hazard ratio, 0.90; 95% CI, 0.60 to 1.35; P = 0.608). Overall survival was also similar with 25 events (13%) versus 31 (16%; adjusted hazard ratio, 1.12; 95% CI, 0.64 to 1.96; P = 0.697). There was also no significant difference in cancer-specific survival with 24 events (12%) versus 29 (15%; adjusted hazard ratio, 1.08; 95% CI, 0.61 to 1.91; P = 0.802). Patients assigned to combined epidural-general had more intraoperative hypotension: 94 patients (47%) versus 121 (61%; relative risk, 1.29; 95% CI, 1.07 to 1.55; P = 0.007).

CONCLUSIONS

Epidural anesthesia-analgesia for major lung cancer surgery did not improve recurrence-free, overall, or cancer-specific survival compared with general anesthesia alone, although the CI included both substantial benefit and harm.

摘要

背景

区域麻醉和镇痛可减轻手术应激反应,减少挥发性麻醉剂和阿片类药物的需求,从而保护癌症特异性免疫防御。因此,本研究旨在检验主要假设,即硬膜外麻醉-镇痛联合全身麻醉是否能改善肺癌手术后无复发生存。

方法

拟行电视辅助胸腔镜肺癌切除术的成年人以 1:1 的比例随机分为全身麻醉加静脉阿片类药物镇痛组或硬膜外-全身麻醉联合硬膜外镇痛组。主要结局是无复发生存(从手术到最早复发/转移或全因死亡的时间)。次要结局包括总生存(从手术到全因死亡的时间)和癌症特异性生存(从手术到癌症特异性死亡的时间)。长期结局评估者对治疗情况不知情。

结果

2015 年 5 月至 2017 年 11 月,共纳入并随机分配 400 例患者至单纯全身麻醉组(n=200)或联合硬膜外-全身麻醉组(n=200)。所有患者均纳入分析。中位随访时间为 32 个月(四分位距 24 至 48)。两组无复发生存率相似,单纯全身麻醉组有 54 例(27%),联合硬膜外-全身麻醉组有 48 例(24%)(调整后的危险比,0.90;95%CI,0.60 至 1.35;P=0.608)。总生存率也相似,单纯全身麻醉组有 25 例(13%),联合硬膜外-全身麻醉组有 31 例(16%)(调整后的危险比,1.12;95%CI,0.64 至 1.96;P=0.697)。癌症特异性生存率也无显著差异,单纯全身麻醉组有 24 例(12%),联合硬膜外-全身麻醉组有 29 例(15%)(调整后的危险比,1.08;95%CI,0.61 至 1.91;P=0.802)。接受联合硬膜外-全身麻醉的患者术中低血压发生率更高:94 例(47%)比 121 例(61%)(相对风险,1.29;95%CI,1.07 至 1.55;P=0.007)。

结论

与单纯全身麻醉相比,硬膜外麻醉-镇痛用于大型肺癌手术并未改善无复发生存、总生存或癌症特异性生存,尽管 CI 包括了实质性获益和危害。

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