阿戈美拉汀 25-50mg 治疗广泛性焦虑障碍焦虑症状和功能损害的疗效：三项安慰剂对照研究的荟萃分析。
Efficacy of Agomelatine 25-50 mg for the Treatment of Anxious Symptoms and Functional Impairment in Generalized Anxiety Disorder: A Meta-Analysis of Three Placebo-Controlled Studies.
机构信息
SAMRC Unit on Risk and Resilience in Mental Disorders, Department of Psychiatry and Neuroscience Institute, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.
Toowong Specialist Clinic, Toowong, Brisbane, Australia.
出版信息
Adv Ther. 2021 Mar;38(3):1567-1583. doi: 10.1007/s12325-020-01583-9. Epub 2021 Feb 4.
INTRODUCTION
The purpose of this study is to investigate the effects of agomelatine on anxious symptoms and functional impairment in a pooled dataset from randomized placebo-controlled trials for generalized anxiety disorder (GAD).
METHODS
Data from three randomized, placebo-controlled trials that evaluated the efficacy of agomelatine 25-50 mg were pooled. The short-term (12 weeks) efficacy of agomelatine was assessed in regards to (1) anxious symptoms using the Hamilton Anxiety Scale (HAM-A), and (2) functional impairment using the Sheehan Disability Scale (SDS). Meta-analysis using a random effect model was used to assess differences between groups. Remission and response rates for the HAM-A and SDS were calculated, and analyses were repeated in participants with more severe anxiety symptoms.
RESULTS
In total, 669 patients (340 on agomelatine; 329 on placebo) were included in the analyses. Compared to placebo, the agomelatine group had a significant reduction in HAM-A total score at week 12 (between group difference: 6.30 ± 2.51, p = 0.012). Significant effects were also found for symptom response on the HAM-A (67.1% of patients on agomelatine vs. 32.5% on placebo) and symptom remission (38.8% of patients on agomelatine vs. 17.3% on placebo). Compared to placebo, there was a significant difference in favour of the agomelatine group at week 12 on the SDS total score (5.11 ± 1.81, p = 0.005). Significant effects were also found for functional response on the SDS (79.1% of patients on agomelatine vs. 43.2% of placebo) and functional remission (55.2% of patients on agomelatine vs. 25.4% on placebo). All findings for anxious symptoms and functional impairment were confirmed in the subset of more severely anxious patients. Agomelatine was well tolerated by patients.
CONCLUSION
This meta-analysis confirms that agomelatine reduces anxiety symptoms and improves the global functioning of GAD patients.
简介
本研究旨在探讨阿戈美拉汀对广泛性焦虑障碍（GAD）随机安慰剂对照试验汇总数据集的焦虑症状和功能障碍的影响。
方法
汇总了三项评估阿戈美拉汀 25-50mg 疗效的随机、安慰剂对照试验的数据。使用汉密尔顿焦虑量表（HAM-A）评估阿戈美拉汀短期（12 周）疗效，使用 Sheehan 残疾量表（SDS）评估功能障碍。采用随机效应模型进行荟萃分析，以评估组间差异。计算 HAM-A 和 SDS 的缓解率和反应率，并在焦虑症状更严重的患者中重复分析。
结果
共有 669 名患者（阿戈美拉汀组 340 名，安慰剂组 329 名）纳入分析。与安慰剂相比，阿戈美拉汀组在第 12 周时 HAM-A 总分显著降低（组间差异：6.30±2.51，p=0.012）。HAM-A 症状反应（阿戈美拉汀组 67.1%的患者 vs. 安慰剂组 32.5%的患者）和症状缓解（阿戈美拉汀组 38.8%的患者 vs. 安慰剂组 17.3%的患者）也有显著效果。与安慰剂相比，第 12 周时 SDS 总分阿戈美拉汀组有显著差异（5.11±1.81，p=0.005）。SDS 功能反应（阿戈美拉汀组 79.1%的患者 vs. 安慰剂组 43.2%的患者）和功能缓解（阿戈美拉汀组 55.2%的患者 vs. 安慰剂组 25.4%的患者）也有显著效果。所有与焦虑症状和功能障碍相关的发现都在焦虑症状更严重的患者亚组中得到了确认。阿戈美拉汀被患者良好耐受。
结论
这项荟萃分析证实，阿戈美拉汀可减轻焦虑症状，改善 GAD 患者的整体功能。
Zotero 插件