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右美沙芬-安非他酮组合(AXS-05)治疗抑郁症的疗效和安全性:一项系统评价与网状Meta分析

Efficacy and safety of dextromethorphan-bupropion combination (AXS-05) in the treatment of depression: A systematic review and network meta-analysis.

作者信息

Ashwin J V, Shahi Mohit Kumar, Singh Astha, Kumar S Theepan

机构信息

Department of Geriatric Mental Health, KGMU, Lucknow, Uttar Pradesh, India.

Department of Psychiatry, Hind Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.

出版信息

Indian J Pharmacol. 2025 Jul 1;57(4):262-268. doi: 10.4103/ijp.ijp_907_24. Epub 2025 Jul 21.

DOI:10.4103/ijp.ijp_907_24
PMID:40686359
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12370225/
Abstract

This network meta-analysis evaluated the efficacy and safety of the dextromethorphan-bupropion combination (AXS-05) in treating major depressive disorder (MDD). Data were retrieved from multiple databases, including PubMed, Embase, Scopus, Google Scholar, and ClinicalKey, yielding 60 records. After removing duplicates and excluding irrelevant studies, such as reviews, case reports, posters, and studies focusing on unrelated populations (e.g., Alzheimer's dementia), two randomized controlled trials (RCTs) - Tabuteau et al. (2022) and Iosifescu et al. (2022) - were selected for final analysis. The inclusion criteria focused on RCTs published between 2014 and 2024, involving adult participants (18-65 years) diagnosed with MDD, and reporting on the efficacy and safety of the dextromethorphan-bupropion combination. Studies that did not focus on MDD, were not in English, or lacked control groups were excluded. The findings indicate superior efficacy of the dextromethorphan-bupropion combination, with remission rates of 46.5% and 39.5%, compared to 16.2% for Bupropion alone and 17.3% for placebo. Despite a higher incidence of mild to moderate adverse events (72.9% vs. 64.6% for Bupropion), the combination's safety profile remained comparable, with no significant increase in treatment discontinuation. These results suggest that AXS-05 is a promising treatment for MDD, warranting further investigation in larger, diverse populations to confirm its long-term efficacy and safety.

摘要

这项网络荟萃分析评估了右美沙芬-安非他酮组合(AXS-05)治疗重度抑郁症(MDD)的疗效和安全性。数据从多个数据库检索,包括PubMed、Embase、Scopus、谷歌学术和ClinicalKey,共获得60条记录。去除重复记录并排除无关研究,如综述、病例报告、海报以及针对不相关人群(如阿尔茨海默病痴呆症)的研究后,选择了两项随机对照试验(RCT)——塔比托等人(2022年)和约西费斯库等人(2022年)——进行最终分析。纳入标准聚焦于2014年至2024年发表的RCT,涉及被诊断为MDD的成年参与者(18至65岁),并报告右美沙芬-安非他酮组合的疗效和安全性。未聚焦于MDD、非英文或缺乏对照组的研究被排除。研究结果表明,右美沙芬-安非他酮组合疗效更佳,缓解率分别为46.5%和39.5%,而单独使用安非他酮的缓解率为16.2%,安慰剂为17.3%。尽管轻度至中度不良事件的发生率较高(安非他酮为64.6%,该组合为72.9%),但该组合的安全性仍相当,治疗中断率无显著增加。这些结果表明,AXS-05是一种有前景的MDD治疗方法,值得在更大、更多样化的人群中进一步研究,以确认其长期疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/0521d8d9b381/IJPharm-57-262-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/0f0a7770467b/IJPharm-57-262-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/0a14043a1df8/IJPharm-57-262-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/eb7c3f7daee5/IJPharm-57-262-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/194fbecbc8fa/IJPharm-57-262-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/0521d8d9b381/IJPharm-57-262-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/0f0a7770467b/IJPharm-57-262-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/0a14043a1df8/IJPharm-57-262-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/eb7c3f7daee5/IJPharm-57-262-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/194fbecbc8fa/IJPharm-57-262-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ebd/12370225/0521d8d9b381/IJPharm-57-262-g005.jpg

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本文引用的文献

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Network meta-analysis (NMA) of dextromethorphan-bupropion (AXS-05) efficacy and safety in major depressive disorder.右美沙芬-安非他酮(AXS-05)治疗重度抑郁症疗效与安全性的网状荟萃分析
Eur Neuropsychopharmacol. 2024 Sep;86:18-19. doi: 10.1016/j.euroneuro.2024.04.016. Epub 2024 Jun 24.
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Dextromethorphan-bupropion (Auvelity) for the Treatment of Major Depressive Disorder.右美沙芬-安非他酮(Auvelity)用于治疗重度抑郁症。
Clin Psychopharmacol Neurosci. 2023 Nov 30;21(4):609-616. doi: 10.9758/cpn.23.1081. Epub 2023 Jul 17.
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Effects of Mental Illness Amongst Adults in the United States Living With Diabetes Mellitus on Hospital Admissions.
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Cureus. 2023 Sep 28;15(9):e46145. doi: 10.7759/cureus.46145. eCollection 2023 Sep.
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Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI).AXS-05(右美沙芬-安非他酮)治疗重度抑郁症患者的疗效和安全性:一项 3 期随机临床试验(GEMINI)。
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Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial.AXS-05(右美沙芬-安非他酮)治疗重性抑郁障碍的疗效:一项随机、双盲对照试验。
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