艾氯胺酮对乳腺癌患者术后抑郁及术前抑郁症状的影响：EASE随机试验

IF 5 2区医学 Q1 ANESTHESIOLOGY

Journal of Clinical Anesthesia Pub Date : 2025-03-27 DOI:10.1016/j.jclinane.2025.111821

Qingfeng Wei MD , Mengmeng Li MD , Qiuling Du MD , Huiwen Zhang MD , Yongjie Liang MD , Cen Cheng MD , Bin Mei MD, PhD , Xiaowei Yang MD, PhD , Yinguang Fan PHD , Jiajia Zhu MD, PhD , Jingjie Zhang MD, PhD , Yongqiang Yu MD, PhD , Qiying Shen MD, PhD , Xuesheng Liu MD, PhD , Daniel I. Sessler MD

{"title":"艾氯胺酮对乳腺癌患者术后抑郁及术前抑郁症状的影响：EASE随机试验","authors":"Qingfeng Wei MD , Mengmeng Li MD , Qiuling Du MD , Huiwen Zhang MD , Yongjie Liang MD , Cen Cheng MD , Bin Mei MD, PhD , Xiaowei Yang MD, PhD , Yinguang Fan PHD , Jiajia Zhu MD, PhD , Jingjie Zhang MD, PhD , Yongqiang Yu MD, PhD , Qiying Shen MD, PhD , Xuesheng Liu MD, PhD , Daniel I. Sessler MD","doi":"10.1016/j.jclinane.2025.111821","DOIUrl":null,"url":null,"abstract":"<div><h3>Study objective</h3><div>To determine whether intraoperative low-dose esketamine ameliorates depression in women having breast cancer surgery.</div></div><div><h3>Design</h3><div>A prospective single-center double blind randomized placebo-controlled trial.</div></div><div><h3>Setting</h3><div>Perioperative period, operating room, post anesthesia care unit and hospital ward.</div></div><div><h3>Patients</h3><div>108 women 18–65 years old who were scheduled for elective breast cancer surgery. All had preoperative depressive symptoms as defined by Montgomery-Åsberg depression scores ≥12 (range, 0–60; higher scores indicate more severe depression).</div></div><div><h3>Interventions</h3><div>Eligible participants were randomized to esketamine 0.25 mg/kg or saline placebo. Blinded trial drugs were given intravenously over the initial 40 min of anesthesia.</div></div><div><h3>Measurements</h3><div>Our primary outcome was the fraction of patients who had at least a 50 % reduction in the Montgomery-Åsberg depression score within 3 postoperative days. Secondary outcomes included the fraction of patients with depression remission defined as Montgomery-Åsberg scores ≤10, the numeric value of the Montgomery-Åsberg depression scores, postoperative severe pain, and anxiety as determined by the Generalized Anxiety Disorder 7-item score. Adverse events were monitored for 72 postoperative hours.</div></div><div><h3>Main results</h3><div>54 women each were randomized to esketamine and saline, and 104 were available for our intent-to-treat analysis. The mean age was 50 years. Esketamine non-significantly doubled the fraction of patients who had a 50 % reduction in their depressions scores: 27 % vs 13 %, odds ratio 2.4, [95 % CI 0.9 to 6.6], <em>P</em> = 0.087. Montgomery-Åsberg depression scores were nearly a factor-of-two and significantly lower (better) on postoperative days 1 to 5 in patients given esketamine. Montgomery-Åsberg scores decreased significantly more from baseline in patients randomized to esketamine: mean difference − 2.5 [95 % CI -4.5 to −0.6], <em>P</em> = 0.010. Esketamine treatment had no significant effect on other secondary outcomes or on adverse events.</div></div><div><h3>Conclusions</h3><div>Intraoperative administration of 0.25 mg/kg esketamine did not significantly improve the fraction of depressed women having breast cancer patients who had a 50 % reduction in their depression scores at 3 days postoperatively. However, the observed factor-of-two treatment effect was clinically meaningful and esketamine significantly reduced short-term postoperative depression scores without provoking complications. Robust trials are warranted.</div><div><strong>Registration Trial registry:</strong> <span><span>http://www.chictr.org.cn/;</span><svg><path></path></svg></span> Identifier: ChiCTR2300071062.</div></div>","PeriodicalId":15506,"journal":{"name":"Journal of Clinical Anesthesia","volume":"103 ","pages":"Article 111821"},"PeriodicalIF":5.0000,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of esketamine on postoperative depression in women with breast cancer and preoperative depressive symptoms: The EASE randomized trial\",\"authors\":\"Qingfeng Wei MD , Mengmeng Li MD , Qiuling Du MD , Huiwen Zhang MD , Yongjie Liang MD , Cen Cheng MD , Bin Mei MD, PhD , Xiaowei Yang MD, PhD , Yinguang Fan PHD , Jiajia Zhu MD, PhD , Jingjie Zhang MD, PhD , Yongqiang Yu MD, PhD , Qiying Shen MD, PhD , Xuesheng Liu MD, PhD , Daniel I. Sessler MD\",\"doi\":\"10.1016/j.jclinane.2025.111821\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Study objective</h3><div>To determine whether intraoperative low-dose esketamine ameliorates depression in women having breast cancer surgery.</div></div><div><h3>Design</h3><div>A prospective single-center double blind randomized placebo-controlled trial.</div></div><div><h3>Setting</h3><div>Perioperative period, operating room, post anesthesia care unit and hospital ward.</div></div><div><h3>Patients</h3><div>108 women 18–65 years old who were scheduled for elective breast cancer surgery. All had preoperative depressive symptoms as defined by Montgomery-Åsberg depression scores ≥12 (range, 0–60; higher scores indicate more severe depression).</div></div><div><h3>Interventions</h3><div>Eligible participants were randomized to esketamine 0.25 mg/kg or saline placebo. Blinded trial drugs were given intravenously over the initial 40 min of anesthesia.</div></div><div><h3>Measurements</h3><div>Our primary outcome was the fraction of patients who had at least a 50 % reduction in the Montgomery-Åsberg depression score within 3 postoperative days. Secondary outcomes included the fraction of patients with depression remission defined as Montgomery-Åsberg scores ≤10, the numeric value of the Montgomery-Åsberg depression scores, postoperative severe pain, and anxiety as determined by the Generalized Anxiety Disorder 7-item score. Adverse events were monitored for 72 postoperative hours.</div></div><div><h3>Main results</h3><div>54 women each were randomized to esketamine and saline, and 104 were available for our intent-to-treat analysis. The mean age was 50 years. Esketamine non-significantly doubled the fraction of patients who had a 50 % reduction in their depressions scores: 27 % vs 13 %, odds ratio 2.4, [95 % CI 0.9 to 6.6], <em>P</em> = 0.087. Montgomery-Åsberg depression scores were nearly a factor-of-two and significantly lower (better) on postoperative days 1 to 5 in patients given esketamine. Montgomery-Åsberg scores decreased significantly more from baseline in patients randomized to esketamine: mean difference − 2.5 [95 % CI -4.5 to −0.6], <em>P</em> = 0.010. Esketamine treatment had no significant effect on other secondary outcomes or on adverse events.</div></div><div><h3>Conclusions</h3><div>Intraoperative administration of 0.25 mg/kg esketamine did not significantly improve the fraction of depressed women having breast cancer patients who had a 50 % reduction in their depression scores at 3 days postoperatively. However, the observed factor-of-two treatment effect was clinically meaningful and esketamine significantly reduced short-term postoperative depression scores without provoking complications. Robust trials are warranted.</div><div><strong>Registration Trial registry:</strong> <span><span>http://www.chictr.org.cn/;</span><svg><path></path></svg></span> Identifier: ChiCTR2300071062.</div></div>\",\"PeriodicalId\":15506,\"journal\":{\"name\":\"Journal of Clinical Anesthesia\",\"volume\":\"103 \",\"pages\":\"Article 111821\"},\"PeriodicalIF\":5.0000,\"publicationDate\":\"2025-03-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Anesthesia\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0952818025000819\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ANESTHESIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Anesthesia","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0952818025000819","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

研究目的确定术中低剂量艾氯胺酮是否能改善乳腺癌手术妇女的抑郁。设计前瞻性单中心双盲随机安慰剂对照试验。围手术期、手术室、麻醉后护理病房、医院病房。患者：108名年龄在18-65岁之间的女性，她们计划进行选择性乳腺癌手术。所有患者术前均有Montgomery定义的抑郁症状-Åsberg抑郁评分≥12(范围0-60；分数越高表明抑郁症越严重)。符合干预条件的参与者被随机分配到艾氯胺酮0.25 mg/kg或生理盐水安慰剂组。盲法试验药物在麻醉的最初40分钟内静脉给予。我们的主要结局是术后3天内Montgomery-Åsberg抑郁评分至少降低50%的患者比例。次要结局包括抑郁缓解的患者比例，定义为Montgomery-Åsberg评分≤10分，Montgomery-Åsberg抑郁评分的数值，术后剧烈疼痛，以及由广泛性焦虑障碍7项评分确定的焦虑。术后72小时监测不良事件。主要结果：54名女性随机接受艾氯胺酮和生理盐水治疗，104名女性可用于意向治疗分析。平均年龄为50岁。艾氯胺酮无显著性地使抑郁评分降低50%的患者比例翻倍：27% vs 13%，优势比2.4,[95% CI 0.9至6.6],P = 0.087。Montgomery-Åsberg抑郁评分几乎是两个因素，在术后第1至5天给予艾氯胺酮的患者抑郁评分明显降低（更好）。随机接受艾氯胺酮治疗的患者Montgomery-Åsberg评分较基线显著下降：平均差值为- 2.5 [95% CI -4.5至- 0.6],P = 0.010。艾氯胺酮治疗对其他次要结局或不良事件没有显著影响。结论术中给予0.25 mg/kg艾氯胺酮并不能显著提高乳腺癌患者抑郁女性的比例，后者在术后3天抑郁评分降低50%。然而，观察到的双因素治疗效果具有临床意义，艾氯胺酮显著降低术后短期抑郁评分，且无并发症。有必要进行有力的试验。试验登记处：http://www.chictr.org.cn/；标识符:ChiCTR2300071062。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Effect of esketamine on postoperative depression in women with breast cancer and preoperative depressive symptoms: The EASE randomized trial

Study objective

To determine whether intraoperative low-dose esketamine ameliorates depression in women having breast cancer surgery.

Design

A prospective single-center double blind randomized placebo-controlled trial.

Setting

Perioperative period, operating room, post anesthesia care unit and hospital ward.

Patients

108 women 18–65 years old who were scheduled for elective breast cancer surgery. All had preoperative depressive symptoms as defined by Montgomery-Åsberg depression scores ≥12 (range, 0–60; higher scores indicate more severe depression).

Interventions

Eligible participants were randomized to esketamine 0.25 mg/kg or saline placebo. Blinded trial drugs were given intravenously over the initial 40 min of anesthesia.

Measurements

Our primary outcome was the fraction of patients who had at least a 50 % reduction in the Montgomery-Åsberg depression score within 3 postoperative days. Secondary outcomes included the fraction of patients with depression remission defined as Montgomery-Åsberg scores ≤10, the numeric value of the Montgomery-Åsberg depression scores, postoperative severe pain, and anxiety as determined by the Generalized Anxiety Disorder 7-item score. Adverse events were monitored for 72 postoperative hours.

Main results

54 women each were randomized to esketamine and saline, and 104 were available for our intent-to-treat analysis. The mean age was 50 years. Esketamine non-significantly doubled the fraction of patients who had a 50 % reduction in their depressions scores: 27 % vs 13 %, odds ratio 2.4, [95 % CI 0.9 to 6.6], P = 0.087. Montgomery-Åsberg depression scores were nearly a factor-of-two and significantly lower (better) on postoperative days 1 to 5 in patients given esketamine. Montgomery-Åsberg scores decreased significantly more from baseline in patients randomized to esketamine: mean difference − 2.5 [95 % CI -4.5 to −0.6], P = 0.010. Esketamine treatment had no significant effect on other secondary outcomes or on adverse events.

Conclusions

Intraoperative administration of 0.25 mg/kg esketamine did not significantly improve the fraction of depressed women having breast cancer patients who had a 50 % reduction in their depression scores at 3 days postoperatively. However, the observed factor-of-two treatment effect was clinically meaningful and esketamine significantly reduced short-term postoperative depression scores without provoking complications. Robust trials are warranted.

Registration Trial registry: http://www.chictr.org.cn/; Identifier: ChiCTR2300071062.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Journal of Clinical Anesthesia 医学-麻醉学

CiteScore

7.40

自引率

4.50%

发文量

346

审稿时长

23 days

期刊介绍： The Journal of Clinical Anesthesia (JCA) addresses all aspects of anesthesia practice, including anesthetic administration, pharmacokinetics, preoperative and postoperative considerations, coexisting disease and other complicating factors, cost issues, and similar concerns anesthesiologists contend with daily. Exceptionally high standards of presentation and accuracy are maintained. The core of the journal is original contributions on subjects relevant to clinical practice, and rigorously peer-reviewed. Highly respected international experts have joined together to form the Editorial Board, sharing their years of experience and clinical expertise. Specialized section editors cover the various subspecialties within the field. To keep your practical clinical skills current, the journal bridges the gap between the laboratory and the clinical practice of anesthesiology and critical care to clarify how new insights can improve daily practice.