Moon Seok Woo, Kim Jee Wook, Kim Do Hoon, Adair Michael, Åström Daniel Oudin, Reines Elin Heldbo, Lee Minah, Kim Gayoung
Department of Psychiatry and Research Institute of Medical Science, Konkuk University School of Medicine, Chungju, South Korea.
Department of Neuropsychiatry, Hallym University Dongtan Sacred Heart Hospital, Dongtan, Korea.
Neuropsychiatr Dis Treat. 2024 Nov 26;20:2299-2311. doi: 10.2147/NDT.S478804. eCollection 2024.
Patients with major depressive disorder (MDD) experience depressive symptoms such as anhedonia as well as cognitive dysfunction which can subsequently impair their work performance.
To assess the effectiveness and safety of vortioxetine in working patients with MDD in South Korea.
This was a subgroup analysis of a prospective, multicenter, non-interventional, non-comparative post-marketing surveillance (PMS) study. Vortioxetine-naïve patients aged >18 years who were administered with vortioxetine were followed for up to 24±2 weeks. Working patients were defined as those who were working or studying full- (≥6 hours/day) or part-time (<6 hours/day) at baseline. Effectiveness and adverse events (AEs), assessed by both clinician and patient-reported measured, were analyzed.
A total of 1082 working patients (mean age: 39.56 years) were included in the subgroup analysis. Clinically significant improvements in depressive symptoms, including anhedonia, were observed over the 24 weeks of follow-up, with mean scores for the total Montgomery-Asberg Depression Rating Scale (MADRS) and anhedonia subscale both significantly decreasing from baseline by mean±standard deviation (SD) of 9.73±9.08 and 5.37±5.24 points, respectively, at 24 weeks (both p<0.001 vs baseline). The vast majority of patients (80.01%) treated with vortioxetine also showed improvements in mental health symptoms over the 24 weeks, measured using the Clinical Global Impression - Improvement (CGI-I) scores. Significant improvements in cognitive symptoms were also observed over the study period, measured by the Korean Version of the Perceived Deficits Questionnaire-Depression as well as Digit Symbol Substitution Test (all p<0.0001 from baseline at Visits 2 and 3). Vortioxetine was well tolerated in working patients, with the respective rates of any AEs and serious AEs being 18.67% and 1.20%.
Working patients treated with vortioxetine had improvements in their depressive symptoms (including anhedonia), cognitive function and performance. Vortioxetine was found to be well tolerated in this study.
重度抑郁症（MDD）患者会出现如快感缺失等抑郁症状以及认知功能障碍，这随后可能会损害他们的工作表现。
评估伏硫西汀在韩国工作的MDD患者中的有效性和安全性。
这是一项前瞻性、多中心、非干预、非对照的上市后监测（PMS）研究的亚组分析。对年龄大于18岁、首次使用伏硫西汀的患者进行长达24±2周的随访。工作患者定义为在基线时全职（≥6小时/天）或兼职（<6小时/天）工作或学习的患者。分析了由临床医生和患者报告测量评估的有效性和不良事件（AE）。
共有1082名工作患者（平均年龄：39.56岁）纳入亚组分析。在24周的随访中观察到抑郁症状（包括快感缺失）有临床显著改善，蒙哥马利-艾斯伯格抑郁评定量表（MADRS）总分及快感缺失子量表的平均得分在24周时分别较基线显著降低，平均±标准差（SD）分别为9.73±9.08和5.37±5.24分（两者与基线相比p<0.001）。使用临床总体印象-改善（CGI-I）评分衡量，绝大多数接受伏硫西汀治疗的患者（80.01%）在24周内心理健康症状也有所改善。在研究期间，通过韩国版感知缺陷问卷-抑郁以及数字符号替换测试测量，认知症状也有显著改善（在第2次和第３次访视时与基线相比均p<0.0001）。伏硫西汀在工作患者中耐受性良好，任何AE和严重AE的发生率分别为18.67%和1.20%。
接受伏硫西汀治疗的工作患者的抑郁症状（包括快感缺失）、认知功能和工作表现均有改善。在本研究中发现伏硫西汀耐受性良好。
