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伏硫西汀在中国患有重度抑郁症的在职患者中的疗效:RELIEVE中国研究的亚组分析

Effectiveness of Vortioxetine in Working Patients with Major Depressive Disorder in China: A Subgroup Analysis of the RELIEVE China Study.

作者信息

Wang Gang, Si Tianmei, Rieckmann Andreas, Ma Jingdong, Christensen Michael Cronquist

机构信息

The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital & The Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, People's Republic of China.

Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, People's Republic of China.

出版信息

Neuropsychiatr Dis Treat. 2024 Jun 7;20:1211-1223. doi: 10.2147/NDT.S460408. eCollection 2024.

Abstract

BACKGROUND

Major depressive disorder (MDD) causes significant functional impairments that impact on all aspects of patients' daily lives, including their ability to work, work productivity, and social life.

PURPOSE

To assess the real-world effectiveness of the multimodal antidepressant vortioxetine in working patients with MDD in China.

PATIENTS AND METHODS

RELIEVE China was an observational, prospective cohort study. Patients (aged ≥18 years) with MDD initiating treatment with vortioxetine in routine clinical practice settings were followed for 24 weeks. In this subgroup analysis, functioning was assessed using the Sheehan Disability Scale (SDS) in patients in full- or part-time work or education at baseline who remained on treatment at all follow-up visits (n=424). Depressive, cognitive, and anxiety symptoms were also assessed. For all endpoints, mean change from baseline at weeks 8 and 24 was analyzed using mixed models for repeated measures.

RESULTS

Clinically relevant and sustained improvements in patient functioning and measures of work productivity were observed over the 24 weeks of vortioxetine treatment. The adjusted mean (standard error) reduction in SDS total score from baseline was 5.4 (0.3) points at week 8 and 8.7 (0.3) points at week 24 (both <0.001 vs baseline). Significant improvements were observed across all SDS domains and in levels of absenteeism and presenteeism (<0.001 vs baseline for all endpoints at both time points). Significant improvements in depressive, cognitive, and anxiety symptoms were also observed over the study period (all <0.001 vs baseline). The proportion of patients in remission (ie, 17-item Hamilton Depression Rating Scale score ≤7) after 24 weeks of vortioxetine treatment was 65.4%. Vortioxetine was well tolerated; nausea was the most common adverse event, reported by 18.6% of patients.

CONCLUSION

These findings support the effectiveness and tolerability of vortioxetine in working patients with MDD receiving treatment in routine clinical practice settings in China.

摘要

背景

重度抑郁症(MDD)会导致严重的功能障碍,影响患者日常生活的方方面面,包括工作能力、工作效率和社交生活。

目的

评估多模式抗抑郁药伏硫西汀在中国患有MDD的在职患者中的实际疗效。

患者与方法

“缓解中国”研究是一项观察性前瞻性队列研究。在常规临床实践环境中开始使用伏硫西汀治疗的MDD患者(年龄≥18岁)被随访24周。在这项亚组分析中,使用希恩残疾量表(SDS)对基线时全职或兼职工作或接受教育且在所有随访中均持续接受治疗的患者(n = 424)的功能进行评估。还评估了抑郁、认知和焦虑症状。对于所有终点,使用重复测量的混合模型分析第8周和第24周相对于基线的平均变化。

结果

在伏硫西汀治疗的24周内,观察到患者功能和工作效率指标有临床相关且持续的改善。SDS总分从基线调整后的平均(标准误)降低在第8周为5.4(0.3)分,在第24周为8.7(0.3)分(两者均与基线相比<0.001)。在所有SDS领域以及旷工和出勤主义水平方面均观察到显著改善(两个时间点的所有终点与基线相比均<0.001)。在研究期间,抑郁、认知和焦虑症状也有显著改善(所有均与基线相比<0.001)。伏硫西汀治疗24周后缓解的患者比例(即17项汉密尔顿抑郁量表评分≤7)为65.4%。伏硫西汀耐受性良好;恶心是最常见的不良事件,18.6%的患者报告有此症状。

结论

这些发现支持伏硫西汀在接受常规临床实践治疗的中国患有MDD的在职患者中的有效性和耐受性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e516/11166150/f169bc374c8e/NDT-20-1211-g0001.jpg

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