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一项在中国单中心进行的托坦司琼柠檬酸酯联合艾司西酞普兰治疗血管性抑郁症的疗效和安全性对照研究:一项初步随机对照试验。

A controlled study of the efficacy and safety of tandospirone citrate combined with escitalopram in the treatment of vascular depression: A pilot randomized controlled trial at a single-center in China.

机构信息

Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.

Department of Neurology, Fujian Medical University Union Hospital, Fuzhou, PR China; Institute of Cerebral Vascular Disease of Fujian Province, Fuzhou, PR China; Key Laboratory of Brain Aging and Neurodegenerative Diseases, Fujian Key Laboratory of Molecular Neurology, Fujian Medical University, Fuzhou, PR China.

出版信息

J Psychiatr Res. 2019 Jul;114:133-140. doi: 10.1016/j.jpsychires.2019.04.024. Epub 2019 Apr 30.

DOI:10.1016/j.jpsychires.2019.04.024
PMID:31075722
Abstract

Vascular depression can respond poorly to antidepressants. This study aimed to explore the efficacy and safety of tandospirone plus escitalopram for treating vascular depression with anxiety. This pilot randomized controlled trial included consecutive inpatients/outpatients with vascular depression/anxiety at the Department of Neurology, Fujian Medical University Union Hospital, China (January 2014 to December 2016). Among 157 patients screened, 100 were randomly divided into the tandospirone + escitalopram (combination therapy) and escitalopram (monotherapy) groups equally, and then followed for 8 weeks. Efficacy was evaluated using the Hamilton Depression (HAMD), Hamilton Anxiety (HAMA), Clinical Global Impression (CGI) and Mini-Mental State examination (MMSE) scales. Adverse events (AEs) were assessed with the Treatment Emergent Symptom Scale (TESS). HAMD and HAMA scores decreased progressively, showing reductions versus baseline at 1, 2, 4 and 8 weeks in both groups (P < 0.001). HAMD and HAMA scores were lower in the tandospirone + escitalopram group than those in the escitalopram group at 1 and 2 weeks (P < 0.001), but not at 4 and 8 weeks. Improvements in CGI scores (severity, improvement and efficacy indexes) were greater in the tandospirone + escitalopram group than that in the escitalopram group at 1 and 2 weeks (P < 0.01), but not at 4 and 8 weeks. The tandospirone + escitalopram group had higher MMSE scores than that in the escitalopram group at 4 and 8 weeks (P < 0.01). All AEs were mild, and the rates were comparable between groups. Augmentation of escitalopram with tandospirone accelerates the onset of anti-depressive and anxiolytic effects and improves cognitive function in patients with vascular depression and anxiety.

摘要

血管性抑郁对抗抑郁药反应不佳。本研究旨在探讨坦度螺酮联合艾司西酞普兰治疗伴焦虑的血管性抑郁的疗效和安全性。这项前瞻性随机对照试验纳入了 2014 年 1 月至 2016 年 12 月在中国福建医科大学附属协和医院神经内科连续就诊的血管性抑郁/焦虑的住院/门诊患者(157 例)。100 例患者被随机分为坦度螺酮+艾司西酞普兰(联合治疗组)和艾司西酞普兰(单药治疗组),并随访 8 周。采用汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)、临床总体印象量表(CGI)和简易智力状态检查量表(MMSE)评估疗效,采用治疗时出现的症状量表(TESS)评估不良反应(AE)。HAMD 和 HAMA 评分逐渐降低,两组患者在治疗后 1、2、4 和 8 周与基线相比均有下降(P<0.001)。联合治疗组在治疗后 1 和 2 周时的 HAMD 和 HAMA 评分均低于艾司西酞普兰组(P<0.001),但在 4 和 8 周时无差异。联合治疗组在治疗后 1 和 2 周时的 CGI 评分(严重程度、改善和疗效指数)改善优于艾司西酞普兰组(P<0.01),但在 4 和 8 周时无差异。联合治疗组在治疗后 4 和 8 周时的 MMSE 评分均高于艾司西酞普兰组(P<0.01)。所有 AE 均为轻度,且两组间发生率相当。在伴焦虑的血管性抑郁患者中,艾司西酞普兰联合坦度螺酮可加速抗抑郁和抗焦虑作用的起效,并改善认知功能。

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