治疗成人抑郁症的伏替西汀:随机对照试验的系统回顾和剂量反应荟萃分析。

IF 5 3区 医学 Q1 CLINICAL NEUROLOGY
Psychiatry and Clinical Neurosciences Pub Date : 2024-09-01 Epub Date: 2024-07-03 DOI:10.1111/pcn.13709
Xin Yang, Shuping Fang, Wenqi Lyu, Yongbo Hu, Huifang Xu, Xiao Jiang, Yurou Zhao, Yuwei Zhang, Jin Li, Weihong Kuang
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引用次数: 0

摘要

目的:重度抑郁障碍(MDD)是一种常见的精神疾病,伏替西汀因其独特的药理特征而具有良好的抗抑郁效果。然而,伏替西汀治疗重度抑郁症的剂量-反应关系尚未明确。我们旨在进行剂量反应荟萃分析,以填补这一空白:我们在多个电子数据库中系统检索了伏替西汀治疗 MDD 的随机对照试验,最后一次检索于 2024 年 2 月 8 日进行。剂量-反应关系采用限制性立方样条模型的单阶段随机效应剂量-反应荟萃分析法进行评估。主要结果是疗效(抑郁量表评分的平均变化),次要结果包括反应、因任何原因退出(可接受性)、因不良事件退出(耐受性)和任何不良事件(安全性):剂量反应荟萃分析包括16项研究,其中4294名参与者被分配到伏替西汀组,2299名参与者被分配到安慰剂组。估计50%有效剂量为4.37毫克/天,近最大有效剂量(95%有效剂量)为17.93毫克/天。剂量-疗效曲线的目测结果表明,20 毫克/天的剂量可能尚未达到峰值。可接受性、耐受性和安全性随着剂量的增加而降低。亚组分析表明,各剂量组在可接受性、耐受性和安全性方面没有观察到显著差异:结论:在不对安全性产生重大影响的情况下,如果超过目前的许可剂量,伏替西汀可能会带来额外的治疗效果。要充分了解其疗效和风险,似乎有必要进行超过当前批准剂量的临床试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Vortioxetine for depression in adults: A systematic review and dose-response meta-analysis of randomized controlled trials.

Aim: Major depressive disorder (MDD) is a prevalent psychiatric condition and vortioxetine offers promising antidepressant effects due to its unique pharmacological profile. However, the dose-response relationships of vortioxetine for MDD is not well established. We aimed to conduct dose-response meta-analyses to fill this gap.

Methods: We systematically searched multiple electronic databases for randomized controlled trials of vortioxetine for MDD, with the last search conducted on 08 February, 2024. The dose-response relationship was evaluated using a one-stage random-effects dose-response meta-analysis with restricted cubic spline model. The primary outcome was efficacy (mean change in depression scale score), with secondary outcomes including response, dropout for any reasons (acceptability), dropout for adverse events (tolerability), and any adverse events (safety).

Results: The dose-response meta-analysis comprised 16 studies, with 4,294 participants allocated to the vortioxetine group and 2,299 participants allocated to the placebo group. The estimated 50% effective dose was 4.37 mg/day, and the near-maximal effective dose (95% effective dose) was 17.93 mg/day. Visual inspection of the dose-efficacy curve suggests that a plateau possibly had not been reached yet at 20 mg/day. Acceptability, tolerability and safety decreased as the dose increased. Subgroup analysis indicated that no significant differences were observed in acceptability, tolerability and safety among the dosage groups.

Conclusions: Vortioxetine may potentially provide additional therapeutic benefits when exceeding the current licensed dosage without significantly impacting safety. Conducting clinical trials exceeding the current approved dosage appears necessary to fully comprehend its efficacy and risk.

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来源期刊
CiteScore
7.40
自引率
4.20%
发文量
181
审稿时长
6-12 weeks
期刊介绍: PCN (Psychiatry and Clinical Neurosciences) Publication Frequency: Published 12 online issues a year by JSPN Content Categories: Review Articles Regular Articles Letters to the Editor Peer Review Process: All manuscripts undergo peer review by anonymous reviewers, an Editorial Board Member, and the Editor Publication Criteria: Manuscripts are accepted based on quality, originality, and significance to the readership Authors must confirm that the manuscript has not been published or submitted elsewhere and has been approved by each author
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