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中华临床医师杂志(电子版) ›› 2022, Vol. 16 ›› Issue (08) : 719 -724. doi: 10.3877/cma.j.issn.1674-0785.2022.08.003

心身医学·临床研究

S-氯胺酮治疗重度抑郁症疗效、安全性观察及机制讨论
林邹卿1, 徐晓燕2, 曹磊明1, 王志强1, 王国强1,(), 张凯3,()   
  1. 1. 214100 江苏无锡,南京医科大学附属无锡精神卫生中心临床心理科
    2. 214100 江苏无锡,无锡市中医医院临床心理科
    3. 238000 合肥,安徽医科大学附属巢湖医院精神科
  • 收稿日期:2021-07-06 出版日期:2022-08-15
  • 通信作者: 王国强, 张凯
  • 基金资助:
    MICB-NKG2D信号通路参与R氯胺酮抗抑郁作用机制研究(M202010)

Efficacy and safety of S-ketamine in treatment of major depressive disorder

Zouqing Lin1, Xiaoyan Xu2, Leiming Cao1, Zhiqiang Wang1, Guoqiang Wang1,(), Kai Zhang3,()   

  1. 1. Department of Psychiatry, Wuxi Mental Health Center, Nanjing Medical University, Wuxi 214100, China
    2. Department of Psychiatry, Wuxi Hospital of Traditional Chinese Medicine, Wuxi 214100, China
    3. Department of Psychiatry, Chaohu Hospital Affiliated to Anhui Medical University, Hefei 238000, China
  • Received:2021-07-06 Published:2022-08-15
  • Corresponding author: Guoqiang Wang, Kai Zhang
引用本文:

林邹卿, 徐晓燕, 曹磊明, 王志强, 王国强, 张凯. S-氯胺酮治疗重度抑郁症疗效、安全性观察及机制讨论[J/OL]. 中华临床医师杂志(电子版), 2022, 16(08): 719-724.

Zouqing Lin, Xiaoyan Xu, Leiming Cao, Zhiqiang Wang, Guoqiang Wang, Kai Zhang. Efficacy and safety of S-ketamine in treatment of major depressive disorder[J/OL]. Chinese Journal of Clinicians(Electronic Edition), 2022, 16(08): 719-724.

目的

本研究目的是观察S-氯胺酮治疗重度抑郁症(MDD)疗效、安全性,并初步探讨S-氯胺酮抗抑郁及可能的急性副反应的机制。

方法

采用治疗前后对照的方法,于2020年10月至2021年12月在无锡市精神卫生中心临床心理科、无锡市中医医院临床心理科以及安徽医科大学附属巢湖医院精神科招募首发或复发的MDD患者40例,受试者入组后被随机归入使用S-氯胺酮联合抗抑郁药治疗组(研究组,20例)和生理盐水加抗抑郁药组(对照组,20例)。S-氯胺酮按0.4 mg/kg单次静脉微量泵缓慢注射给药。分别在S-氯胺酮或生理盐水给药前、给药后24 h、1周末、4周末时采用蒙哥马利抑郁评定量表(MADRS)等评估患者症状;采用6项临床解离症状量表评估患者解离症状。采用重复测量方差分析比较研究组和对照组治疗前后症状评分差异,当P<0.05时,认为差异具有统计学意义。

结果

研究组和对照组经治疗均出现MARDS评分下降趋势,并且2组存在分组差异(P<0.05);研究组评分在24 h,1周末和4周末时均优于对照组,其中24 h差异最显著。在S-氯胺酮给药24 h后,有5例患者(25%)达到了完全缓解(MADRS≤10),另有5例患者达到有效缓解(MARDS降分≥30%),9例患者部分缓解。

结论

S-氯胺酮是一种快速、有效、安全的新型抗抑郁药,单次小剂量静脉用药也有较好的疗效。

Objective

To observe the efficacy and safety of S-ketamine in the treatment of major depressive disorder (MDD), and to preliminarily explore the mechanism of antidepressant and possible acute side effects of S-ketamine.

Methods

From October 2020 to December 2021, 40 patients with newly diagnosed or recurrent MDD were recruited at the Department of Clinical Psychology of Wuxi Mental Health Center, the Department of Clinical Psychology of Wuxi Hospital of traditional Chinese Medicine, and the Department of Psychiatry of Chaohu Hospital affiliated to Anhui Medical University. The subjects were randomly divided into either a study group, which was treated with S-ketamine combined with antidepressants (n=20), or a control group (n=20), which was treated with normal saline combined with antidepressants. S-ketamine was administered at 0.4 mg/kg by single injection with a micropump. The symptoms of patients were evaluated by the Montgomery-?sberg Depression Rating Scale (MADRS) before the administration of S-ketamine or normal saline and at 24 hours, 1 week, and 4 weeks after administration. The dissociative effects were evaluated by 6-item clinician administered dissociative symptom scale. Repeated measures analysis of variance was used to compare the differences in symptom scores pre- and post-treatment between the two groups. P<0.05 was considered statistically significant.

Results

The scores of MARDS decreased after treatment in both group, and there was a significant difference between the two groups (P<0.05). The MARDS score of the study group was better than that of the control group at 24 hours, 1 week, and 4 weeks, among which the 24-hour difference was the most significant. Twenty-four hours after administration of S-ketamine, five patients achieved complete remission (MADRS score ≤10), five achieved remarked remission (MARDS scores decreased by ≥30% from baseline), and nine achieved partial remission.

Conclusion

S-ketamine is a rapid, effective, and safe new antidepressant, and single low-dose intravenous administration has a good effect.

表1 一般信息比较(
xˉ
±s
表2 研究组与对照组蒙哥马利量表评分结果(
xˉ
±s
表3 研究组与对照组蒙哥马利量表评分多变量检验结果
图1 研究组与对照组蒙哥马利量表评分边际平均值变化趋势示例图
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