【罂粟摘要】术中右美托咪定对拟行大型非心脏手术的​老年患者术后长期生存的影响:一项随访3年的随机试验

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术中右美托咪定对拟行大型非心脏手术的老年患者术后长期生存的影响:一项随访3年的随机试验

贵州医科大学   麻醉与心脏电生理课题组

翻译：潘志军

编辑：宋雨婷

审校：曹莹

目的

评估术中使用右美托咪定对拟行大型非心脏手术的老年癌症患者长期预后的影响。 

试验设计、地点及受试对象

该试验为一项需对受试对象进行三年随访的随机试验，于中国北京市一家三级康复医院进行。受试对象为年纪≥60岁且拟行大型非心脏手术的患者。

干预措施及测量方法

受试对象在麻醉期间随机接受右美托咪定(0.6 ug/kg的负荷剂量超过10分钟；然后持续输注0.5 ug/kg/h，直到手术结束前1小时)或安慰剂。主要指标为生存率，次要指标包括无复发生存率和无事件生存率。采用Cox比例风险模型调整预定的混杂因素，倾向性评分匹配进行灵敏性分析。

结果

在初始试验随机抽取的620例患者中，619例被纳入该项研究(平均年龄69岁，40%为女性，77%为肿瘤手术患者)。中位随访时间为42个月(四分位数间距 41 ~ 45)。两组患者的总生存期无差异：右美托咪定组 49/309例(15.9%)死亡，安慰剂组 63/310例(20.3%)死亡(校正危险比 [HR] 0.78, 95% CI 0.53-1.13, P = 0.187)。右美托咪定改善无复发生存率(右美托咪定 68/309[22.0%]，安慰剂 98/310 [31.6%]；校正HR 0.67, 95% CI 0.49 ~ 0.92, P = 0.012)、无事件生存率(右美托咪定组 120/309[38.8%]事件，安慰剂组145/310[46.8%]事件；校正HR 0.78, 95% CI 0.61-1.00, P = 0.047)。倾向性评分匹配后的结果与癌症患者亚组相似。

结论

在拟行大型非心脏手术的老年癌症患者中，术中右美托咪定不能提高总生存率，但与改善无复发生存率和无事件生存率相关。

原始文献来源

Mao-Wei Xing,Chun-Jing Li, Chao Guo,et al.Effect of intraoperative dexmedetomidine on long-term survival in older patients after major noncardiac surgery: 3-year follow-up of a randomized trial [J]. (J Clin Anesth. 2023 Jun;86:111068).

英文原文

Effect of intraoperative dexmedetomidine on long-term survival in older patients after major noncardiac surgery: 3-year follow-up of a randomized trial     

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.   

-End-

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