术中右美托咪定对老年非心脏大手术后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.

机构信息

Department of Anesthesiology, Peking University First Hospital, Beijing, China.

Department of Anesthesiology, Peking University First Hospital, Beijing, China; Department of Anesthesiology, the University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong, China.

出版信息

J Clin Anesth. 2023 Jun;86:111068. doi: 10.1016/j.jclinane.2023.111068. Epub 2023 Feb 1.

DOI:10.1016/j.jclinane.2023.111068

PMID:36736209

Abstract

STUDY OBJECTIVE

To assess the impact of intraoperative dexmedetomidine on long-term outcomes of older patients following major noncardiac surgery mainly for cancer.

DESIGN

A long-term follow-up of patients enrolled in a randomized trial.

SETTING

The initial trial was performed in a tertiary care hospital in Beijing, China.

PARTICIPANTS

Patients aged 60 years or older who were scheduled for major noncardiac surgery.

INTERVENTION

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.

MEASUREMENTS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

研究目的

评估围术期给予右美托咪定对主要接受非心脏手术（主要为癌症）的老年患者长期结局的影响。

设计

对参加随机试验的患者进行长期随访。

地点

该初始试验在北京的一家三级护理医院进行。

参与者

年龄在 60 岁或以上、计划接受非心脏大手术的患者。

干预措施

患者在麻醉期间被随机分配接受右美托咪定（负荷剂量 0.6μg/kg 持续 10 分钟，然后以 0.5μg/kg/h 的速度连续输注直至手术结束前 1 小时）或安慰剂。

测量

主要终点为总生存。次要终点包括无复发生存和无事件生存。使用 Cox 比例风险模型调整预先设定的混杂因素。采用倾向评分匹配进行敏感性分析。

结果

在初始试验中随机分组的 620 例患者中，619 例纳入长期分析（平均年龄 69 岁，40%为女性，77%为肿瘤手术）。中位随访时间为 42 个月（四分位间距 41 至 45）。两组之间总生存率无差异：右美托咪定组有 49/309（15.9%）例死亡，安慰剂组有 63/310（20.3%）例死亡（调整后的风险比[HR]0.78，95%CI0.53-1.13，P=0.187）。无复发生存率得到改善，右美托咪定组（右美托咪定组 68/309[22.0%]例事件，安慰剂组 98/310[31.6%]例事件；调整后的 HR0.67，95%CI0.49-0.92，P=0.012）。无事件生存率也得到改善，右美托咪定组（右美托咪定组 120/309[38.8%]例事件，安慰剂组 145/310[46.8%]例事件；调整后的 HR0.78，95%CI0.61-1.00，P=0.047）。倾向评分匹配后和癌症患者亚组中结果相似。