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Comments to Drs Taillefer de Laportalière, Jullien, Yrondi, Cestac, and Montastruc.

作者信息

Fu Dong-Jing, Bossie Cynthia A, Lane Rosanne, Janik Adam, Canuso Carla M, Drevets Wayne C

机构信息

Department of Neuroscience Clinical Development, Janssen Research & Development, LLC, Titusville, NJ, USA.

Department of Clinical Statistics, Janssen Research & Development, LLC, Titusville, NJ, USA.

出版信息

Psychol Med. 2023 Dec;53(16):7980-7982. doi: 10.1017/S0033291723002490. Epub 2023 Aug 23.

DOI:10.1017/S0033291723002490
PMID:37609792
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10755219/
Abstract
摘要

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本文引用的文献

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Reporting of harms in clinical trials of esketamine in depression: a systematic review.报告在抑郁症的氯胺酮临床试验中的伤害：系统评价。
Psychol Med. 2023 Jul;53(10):4305-4315. doi: 10.1017/S0033291723001058. Epub 2023 Apr 26.
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Long-term safety and maintenance of response with esketamine nasal spray in participants with treatment-resistant depression: interim results of the SUSTAIN-3 study.依他佐辛鼻喷雾剂治疗难治性抑郁症患者的长期安全性和疗效维持：SUSTAIN-3 研究的中期结果。
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CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials.CONSORT危害声明2022：解释与阐述——随机对照试验中危害报告的更新指南
BMJ. 2023 Apr 24;381:e073725. doi: 10.1136/bmj-2022-073725.
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Adverse Events and Measurement of Dissociation After the First Dose of Esketamine in Patients With TRD.抗抑郁治疗药物反应障碍患者首次使用依他佐辛后的不良事件和分离测量。
Int J Neuropsychopharmacol. 2023 Mar 22;26(3):198-206. doi: 10.1093/ijnp/pyac081.
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Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression.依他佐辛鼻喷剂治疗难治性抑郁症的 3 期临床试验汇总数据的事后分析：不良事件的纵向病程。
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Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression.（标题）：难治性抑郁症患者使用氯胺酮鼻喷雾剂的解离与抗抑郁作用之间的关系。
Int J Neuropsychopharmacol. 2022 Apr 19;25(4):269-279. doi: 10.1093/ijnp/pyab084.
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Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies.鼻内应用氯胺酮对治疗抵抗性抑郁症患者嗅觉功能和鼻腔耐受性的影响：四项多中心、随机、双盲、安慰剂对照 III 期研究的结果。
CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.
8
Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression.依他佐辛鼻喷剂与安慰剂治疗难治性抑郁症的获益-风险评估。
Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.
9
Appraising esketamine nasal spray for the management of treatment-resistant depression in adults: Number needed to treat, number needed to harm, and likelihood to be helped or harmed.评估依他佐辛鼻喷雾剂治疗成人治疗抵抗性抑郁症：需要治疗的人数、需要伤害的人数以及帮助或伤害的可能性。
J Affect Disord. 2020 Jun 15;271:228-238. doi: 10.1016/j.jad.2020.03.106. Epub 2020 Apr 3.
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Cardiac Safety of Esketamine Nasal Spray in Treatment-Resistant Depression: Results from the Clinical Development Program.盐酸依他佐辛鼻喷雾剂治疗难治性抑郁症的心脏安全性：来自临床开发项目的结果。
CNS Drugs. 2020 Mar;34(3):299-310. doi: 10.1007/s40263-020-00699-4.