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单次固定剂量鼻内给予氯胺酮以减轻急性自杀意念。急诊科的跨诊断方法:一项随机、双盲、安慰剂对照的概念验证试验。

Single, Fixed-Dose Intranasal Ketamine for Alleviation of Acute Suicidal Ideation. An Emergency Department, Trans-Diagnostic Approach: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial.

作者信息

Domany Yoav, McCullumsmith Cheryl B

出版信息

Arch Suicide Res. 2022 Jul-Sep;26(3):1250-1265. doi: 10.1080/13811118.2021.1878078. Epub 2021 Feb 14.

DOI:10.1080/13811118.2021.1878078
PMID:33583341
Abstract

BACKGROUND

Suicidal patients often present to the emergency department, where specific anti-suicidal treatment is lacking. Ketamine, a Glutamate modulator and a rapidly acting antidepressant with anti-suicidal properties, might offer relief.

AIMS

Evaluation of single, fixed-dosed intranasal ketamine for acute suicidal ideation in the emergency department.

METHODS

Between August 2016 and April 2018, 30 eligible suicidal subjects, scheduled for psychiatric hospitalization, independently of their psychiatric diagnosis, were randomized to intranasal ketamine 40 mg or saline placebo. Safety and efficacy evaluations were scheduled for 30, 60, 120 and 240 min post administration and on days 1, 2, 3, 4, 5, 7, 21 and 28. Primary outcome was suicidal ideation.

RESULTS

Fifteen subjects were randomized for each study group. All were analyzed for primary and secondary outcomes. Four hours post administration, the mean difference in suicidal symptoms between the groups, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) item of suicidal thoughts (MADRS-SI), was 1.267 (95% confident interval 0.1-2.43,  < 0.05) favoring treatment. Remission from suicidal ideation was evident in 80% for the ketamine group compared with 33% for the controls ( < 0.05). The mean difference in depressive symptoms, measured by MADRS, at the same time was 9.75 (95% confident interval 0.72-18.79,  < 0.05) favoring ketamine. Treatment was safe and well-tolerated.

CONCLUSIONS

Single, fixed-dose, intranasal ketamine alleviated suicidal ideation and improved depressive symptoms four hours post administration. We present here an innovative paradigm for emergency department management of suicidal individuals. Future larger-scale studies are warranted. NCT02183272.

摘要

背景

有自杀倾向的患者常前往急诊科就诊,而急诊科缺乏特定的抗自杀治疗方法。氯胺酮作为一种谷氨酸调节剂和具有抗自杀特性的速效抗抑郁药,可能会带来缓解效果。

目的

评估单剂量、固定剂量的鼻内氯胺酮用于急诊科急性自杀意念的治疗效果。

方法

在2016年8月至2018年4月期间,30名符合条件的有自杀倾向的受试者,无论其精神科诊断如何,均计划接受精神科住院治疗,他们被随机分为接受40毫克鼻内氯胺酮治疗组或生理盐水安慰剂组。在给药后30、60、120和240分钟以及第1、2、3、4、5、7、21和28天进行安全性和疗效评估。主要结局指标是自杀意念。

结果

每个研究组各有15名受试者被随机分组。所有受试者均对主要和次要结局指标进行了分析。给药4小时后,通过蒙哥马利-Åsberg抑郁评定量表(MADRS)中自杀念头项目(MADRS-SI)测量的两组间自杀症状平均差异为1.267(95%置信区间0.1 - 2.43,P < 0.05),表明治疗组更具优势。氯胺酮组80%的患者自杀意念缓解,而对照组为33%(P < 0.05)。同时,通过MADRS测量的抑郁症状平均差异为9.75(95%置信区间0.72 - 18.79,P < 0.05),表明氯胺酮组更具优势。治疗安全且耐受性良好。

结论

单剂量、固定剂量的鼻内氯胺酮在给药4小时后减轻了自杀意念并改善了抑郁症状。我们在此提出了一种针对急诊科有自杀倾向个体的创新管理模式。未来有必要开展更大规模的研究。NCT02183272。

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