Laboratory of Pharmacology and Brain Biostructure, Maj Institute of Pharmacology, Polish Academy of Sciences, Kraków, Poland.
Department of Neurobiology, Maj Institute of Pharmacology, Polish Academy of Sciences, Kraków, Poland.
Expert Opin Pharmacother. 2020 Jan;21(1):9-20. doi: 10.1080/14656566.2019.1683161. Epub 2019 Oct 30.
: In March 2019, intranasal esketamine was approved by the Food and Drug Administration (FDA) for the treatment of treatment-resistant depression (TRD) in adults. This review presents the results of clinical trials underlying the FDA approval of intranasal esketamine.: Esketamine's efficacy and safety in TRD were assessed in 5 phase III studies: three 4-week, placebo-controlled studies, and two long-term trials. One short-term trial showed statistically significant antidepressant effects of esketamine vs placebo, while a long-term withdrawal study showed that esketamine is significantly beneficial in terms of extending time to relapse, compared to placebo. Two other short-term trials did not meet the prespecified statistical tests for showing efficacy, although improvement in depressive symptoms from baseline to the end of week 4 favors esketamine over placebo.: Intranasal esketamine is a new treatment option for people with TRD. The main benefit of esketamine is rapid onset of antidepressant activity, but the effects of prolonged treatment are still preliminary. The main concerns relate to the safety aspects of prolonged esketamine therapy, when considering its abuse potential. While data for esketamine use over a long period of time is lacking, its use should be carefully monitored.
: 2019 年 3 月，鼻内用氯胺酮获得美国食品和药物管理局（FDA）批准，用于治疗成人治疗抵抗性抑郁症（TRD）。这篇综述介绍了 FDA 批准鼻内用氯胺酮的临床试验结果。
: 在 5 项 III 期研究中评估了氯胺酮治疗 TRD 的疗效和安全性：3 项为期 4 周、安慰剂对照研究，以及 2 项长期试验。一项短期试验显示氯胺酮与安慰剂相比具有统计学显著的抗抑郁作用，而一项长期停药研究表明，与安慰剂相比，氯胺酮在延长复发时间方面具有显著益处。另外两项短期试验虽然在显示疗效方面未达到预设的统计学检验标准，但从基线到第 4 周末抑郁症状的改善倾向于氯胺酮优于安慰剂。
: 鼻内用氯胺酮是治疗 TRD 的一种新的治疗选择。氯胺酮的主要益处是快速起效抗抑郁作用，但长期治疗的效果仍处于初步阶段。主要关注点与延长氯胺酮治疗的安全性方面有关，需要考虑其滥用潜力。虽然缺乏长期使用氯胺酮的数据，但应密切监测其使用情况。
