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艾司氯胺酮与丙泊酚在电休克治疗难治性抑郁症中的疗效和安全性研究：一项随机双盲对照非劣效性试验
贵州医科大学 麻醉与心脏电生理课题组
翻译：宋雨婷 编辑：田明德 审校：曹莹
背景： 电休克治疗（ECT）治疗是难治性抑郁症（TRD）的常用替代方案。虽然艾司氯胺酮具有快速抗抑郁的药理作用，但尚未作为ECT麻醉剂进行研究。本研究的目的是比较艾司氯胺酮或丙泊酚用作ECT麻醉剂的疗效和安全性。
方法： 本研究为一项双盲、随机、对照试验。将40名TRD的患者分为：艾司氯胺酮-ECT组和丙泊酚-ECT组，进行连续八次ECT治疗。使用非劣效性设计，主要结局是HAMD-17抑郁症状的减轻。其他结局是：反应率和缓解率、焦虑发生情况、自杀意向、认知功能和不良事件发生率。在意向性治疗分析中对这些进行了比较。
结果： 艾司氯胺酮-ECT在连续8次治疗后TRD症状减轻不劣于异丙酚-ECT （校正Δ = 2.0，95 % CI：-1.2-5.1）。与丙泊酚-ECT相比，艾司氯胺酮-ECT也具有更高的反应率（80 %比70 %；P = 0.06）和缓解率（65 %比55 %；P = 0.11），但非劣效性尚未建立。在认知功能的四个组成部分中（处理速度、工作记忆、视觉学习和语言学习），艾司氯胺酮-ECT不劣于丙泊酚-ECT。焦虑、自杀意向和不良事件的发生率无显著差异（P > 0.05）。
结论： 当艾司氯胺酮或丙泊酚用作ECT的TRD患者的麻醉剂时，艾司氯胺酮不劣于异丙酚。需使用较大样本进行重复研究来检验本研究未得出结论的结果。
原始文献来源：Zeng QB, Zou DC, Huang XB, et al. Efficacy and safety of esketamine versus propofol in electroconvulsive therapy for treatment-resistant depression: A randomized, double-blind, controlled, non-inferiority trial. J Affect Disord. Published online September 10, 2024.
Efficacy and safety of esketamine versus propofol in electroconvulsive therapy for treatment-resistant depression: A randomized, double-blind, controlled, non-inferiority trial
Abstract
Background: Electroconvulsive therapy (ECT) is a commonly used alternative for treatment-resistant depression (TRD). Although esketamine has a rapid pharmacological antidepressant action, it has not been studied as an ECT anesthetic. The objective of this study was to compare the efficacy and safety of esketamine with propofol when both are used as ECT anesthetic agents.
Methods: Forty patients with TRD were assigned to one of two arms in a double-blind, randomized controlled trial: esketamine or propofol anesthesia for a series of eight ECT sessions. Using a non-inferiority design, the primary outcome was the reduction in HAMD-17 depressive symptoms. The other outcomes were: rates of response and remission, anxiety, suicidal ideation, cognitive function, and adverse events. These were compared in an intention-to-treat analysis.
Results: Esketamine-ECT was non-inferior to propofol-ECT for reducing TRD symptoms after 8 sessions (adjusted Δ = 2.0, 95 % CI: -1.2-5.1). Compared to propofol-ECT, esketamine-ECT also had higher depression response (80 % vs. 70 %; p = .06) and remission (65 % vs. 55 %; p = .11) rates but non-inferiority was not established. In four components of cognitive function (speed of processing, working memory, visual learning, and verbal learning) esketamine-ECT was non-inferior to propofol-ECT. The results for anxiety, suicidal ideation, and adverse events (all p's > 0.05) were inconclusive.
Conclusion: Esketamine was non-inferior to propofol when both are used as anesthetics for TRD patients undergoing ECT. Replication studies with larger samples are needed to examine the inconclusive results.
