围手术期地塞米松对非心脏手术后老年患者长期生存的影响:一项随机试验的3年随访。
Effect of intraoperative dexmedetomidine on long-term survival in older patients after major noncardiac surgery: 3-year follow-up of a randomized trial.
发表日期:2023 Feb 01
作者:
Mao-Wei Xing, Chun-Jing Li, Chao Guo, Bo-Jie Wang, Dong-Liang Mu, Dong-Xin Wang
来源:
JOURNAL OF CLINICAL ANESTHESIA
摘要:
为评估术中使用瑞芬太尼对接受大型非心脏手术的老年患者在癌症方面的长期结果的影响。对一项随机试验中入组患者进行长期随访。该初步试验在北京一家三级医院进行,入选的患者年龄在60岁及以上,需要进行大型非心脏手术。参与者在麻醉期间随机接受瑞芬太尼(负荷剂量为0.6μg/kg,持续静脉输注0.5μg/kg/h至手术结束前1小时)或安慰剂。主要终点是总体生存率,次要终点包括无复发生存率和无事件生存率。使用Cox比例风险模型来调整预先定义的混杂因素。采用倾向得分匹配法进行敏感性分析。在初始试验中随机分组的620名患者中,619名患者被纳入长期分析(平均年龄69岁,女性40%,77%进行肿瘤手术)。中位随访时间为42个月(四分位距为41至45)。两组间总体生存率无差异:使用瑞芬太尼组49/309(15.9%)患者死亡,安慰剂组63/310(20.3%)患者死亡(调整风险比【HR】为0.78,95%置信区间【CI】为0.53-1.13,P = 0.187)。使用瑞芬太尼组复发无生存率有所提高(68/309【22.0%】,安慰剂组98/310【31.6%】;调整HR为0.67,95%CI为0.49-0.92,P = 0.012)。使用瑞芬太尼组无事件生存率也有所提高(120/309【38.8%】,安慰剂组145/310【46.8%】;调整HR为0.78,95%CI为0.61-1.00,P = 0.047)。在倾向得分匹配和肿瘤患者亚组中,结果也相似。在进行主要进行肿瘤手术的老年患者中,术中使用瑞芬太尼并未改善总体生存率,但与改善复发无生存率和无事件生存率相关。版权所有©2023作者。Elsevier Inc.保留所有权利。
To assess the impact of intraoperative dexmedetomidine on long-term outcomes of older patients following major noncardiac surgery mainly for cancer.A long-term follow-up of patients enrolled in a randomized trial.The initial trial was performed in a tertiary care hospital in Beijing, China.Patients aged 60 years or older who were scheduled for major noncardiac surgery.Participants were randomized to receive either dexmedetomidine (a loading dose of 0.6 μg/kg over 10 min, followed by a continuous infusion of 0.5 μg/kg/h until 1 h before end of surgery) or placebo during anesthesia.The primary endpoint was overall survival. Secondary endpoints included recurrence-free survival and event-free survival. Cox proportional hazard models were used to adjust for predefined confounding factors. Propensity score matching was employed for sensitive analysis.Among 620 patients who were randomized in the initial trial, 619 were included in the long-term analysis (mean age 69 years, 40% female, 77% oncological surgery). The median follow-up duration was 42 months (interquartile range 41 to 45). Overall survival did not differ between the two groups: there were 49/309 (15.9%) deaths with dexmedetomidine versus 63/310 (20.3%) with placebo (adjusted hazard ratio [HR] 0.78, 95% CI 0.53-1.13, P = 0.187). Recurrence-free survival was improved with dexmedetomidine (68/309 [22.0%] events with dexmedetomidine versus 98/310 [31.6%] with placebo; adjusted HR 0.67, 95% CI 0.49-0.92, P = 0.012). Event-free survival was also improved with dexmedetomidine (120/309 [38.8%] events with dexmedetomidine versus 145/310 [46.8%] with placebo; adjusted HR 0.78, 95% CI 0.61-1.00, P = 0.047). Results were similar after propensity-score matching and in the subgroup of cancer patients.In older patients having major noncardiac surgery mainly for cancer, intraoperative dexmedetomidine did not improve overall survival but was associated with improved recurrence-free and event-free survivals.Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.