法国蒙彼利埃大学Fabrice Jollant团队研究了氯胺酮用于严重自杀意念急性治疗的临床益处。相关论文于2022年2月2日发表在《英国医学杂志》上。
为了确认氯胺酮总体上和根据诊断分组，在短期和六周内快速起效抗自杀的益处，2015年4月13日至2019年3月12日，研究组在7家法国教学医院进行了一项前瞻性、双盲、优势、随机安慰剂对照试验，招募18岁及以上，有自杀念头，自愿入院的患者。排除有精神分裂症或其他精神疾病史、药物依赖和氯胺酮禁忌症的患者。
将招募到的156名参与者随机分为两组，其中安慰剂组83例，氯胺酮组73例，按中心和诊断分层：双相、抑郁或其他障碍。两组患者除常规治疗外，在基线检查时和24小时内静脉输注两次40分钟的氯胺酮（0.5 mg/kg）或安慰剂（生理盐水）。根据自杀意念总分量表，主要结局为第3天完全自杀缓解（自杀意念总分≤3分）的患者比率。分析是在意向治疗的基础上进行的。
与安慰剂组相比，接受氯胺酮治疗的参与者在第3天达到自杀意念完全缓解的人数更多：氯胺酮组83名受试者中有46名（63.0%），安慰剂组73名受试者中有25名（31.6%），优势比为3.7，组间差异显著。根据诊断：双相的优势比为14.1，抑郁为1.3，其他障碍为3.7。副作用有限。未发现躁狂或精神病症状。此外，还发现了精神疼痛的缓解作用。在第6周，氯胺酮组的缓解率仍然很高，但与安慰剂组相比无显著性差异，分别为69.5%与56.3%。
研究结果表明，氯胺酮在短期内是快速、安全的，并且对自杀患者的急性治疗具有持续益处。共病精神障碍似乎是重要的调节因素。精神疼痛的镇痛作用可能解释了氯胺酮的抗自杀作用。
附：英文原文
Title: Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial
Author: Mocrane Abbar, Christophe Demattei, Wissam El-Hage, Pierre-Michel Llorca, Ludovic Samalin, Pierre Demaricourt, Raphael Gaillard, Philippe Courtet, Guillaume Vaiva, Philip Gorwood, Pascale Fabbro, Fabrice Jollant
Issue&Volume: 2022/02/02
Abstract:
Objective To confirm the rapid onset anti-suicidal benefits of ketamine in the short term and at six weeks, overall and according to diagnostic group.
Design Prospective, double blind, superiority, randomised placebo controlled trial.
Setting Seven French teaching hospitals between 13 April 2015 and 12 March 2019.
Eligibility criteria for participants Aged 18 or older with current suicidal ideation, admitted to hospital voluntarily. Exclusion criteria included a history of schizophrenia or other psychotic disorders, substance dependence, and contraindications for ketamine.
Participants 156 participants were recruited and randomised to placebo (n=83) or ketamine (n=73), stratified by centre and diagnosis: bipolar, depressive, or other disorders.
Intervention Two 40 minute intravenous infusions of ketamine (0.5 mg/kg) or placebo (saline) were administered at baseline and 24 hours, in addition to usual treatment.
Main outcome measures The primary outcome was the rate of patients in full suicidal remission at day 3, according to the scale for suicidal ideation total score ≤3. Analyses were conducted on an intention-to-treat basis.
Results More participants receiving ketamine reached full remission of suicidal ideas at day 3 than those receiving placebo: 46 (63.0%) of 83 participants in the ketamine arm and 25 (31.6%) of 73 in the placebo arm (odds ratio 3.7 (95% confidence interval 1.9 to 7.3), P<0.001). This effect differed according to the diagnosis (treatment: P<0.001; interaction: P=0.02): bipolar (odds ratio 14.1 (95% confidence interval 3.0 to 92.2), P<0.001), depressive (1.3 (0.3 to 5.2), P=0.6), or other disorders (3.7 (0.9 to 17.3, P=0.07)). Side effects were limited. No manic or psychotic symptom was seen. Moreover, a mediating effect of mental pain was found. At week 6, remission in the ketamine arm remained high, although non-significantly versus placebo (69.5% v 56.3%; odds ratio 0.8 (95% confidence interval 0.3 to 2.5), P=0.7).
Conclusions The findings indicate that ketamine is rapid, safe in the short term, and has persistent benefits for acute care in suicidal patients. Comorbid mental disorders appear to be important moderators. An analgesic effect on mental pain might explain the anti-suicidal effects of ketamine.
DOI: 10.1136/bmj-2021-067194
Source: https://www.bmj.com/content/376/bmj-2021-067194
BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
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本期文章：《英国医学杂志》：Online/在线发表
