Efficacy of early administration of escitalopram on depressive and emotional symptoms and neurological dysfunction after stroke: a multicentre, double-blind, randomised, placebo-controlled study
Efficacy of early administration of escitalopram on depressive and emotional symptoms and neurological dysfunction after stroke: a multicentre, double-blind, randomised, placebo-controlled study
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DOI：
10.1016/s2215-0366(16)30417-5
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发表时间：
2017-01-01
影响因子：
64.3
通讯作者：
Choi-Kwon, Smi
中科院分区：
文献类型：
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作者：
Kim, Jong S.;Lee, Eun-Jae;Choi-Kwon, Smi
研究背景情绪和情感障碍在脑卒中患者中很常见，并对临床结局产生不利影响。我们的目的是评估早期管理艾司西酞普兰，以减少中度或重度抑郁症状，改善情绪和神经功能障碍中风patients with stroke.Methods的疗效，这是一个安慰剂对照，双盲试验在17个中心在韩国。在过去21天内发生急性卒中的患者以1：1的比例随机分配接受口服艾司西酞普兰（10 mg/天）或安慰剂治疗3个月。通过基于网络的系统，采用按中心分层的排列区组进行随机化。主要终点是中度或重度抑郁症状的频率（蒙哥马利-艾斯伯格抑郁量表[MADRS] >= 16）。在全分析集（接受研究药物并在随机化后接受主要终点评估的患者）、所有入组并随机分配的患者（意向治疗）和所有完成试验的患者（符合方案分析）中，于随机化后3个月评估终点。该试验注册于ClinicalTrials.gov，编号NCT 01278498。结果在2011年1月27日至2014年6月30日期间，478例患者被分配至安慰剂组（n=237）或艾司西酞普兰组（n=241）; 405例被纳入全分析集（安慰剂组195例，艾司西酞普兰组210例）。在全分析集中，各研究组的主要结局无差异（安慰剂组25例[13%]患者vs艾司西酞普兰组27例[13%];比值比[OR] 1.00，95% CI 0.56-1.80; p>0.99）或意向治疗分析中（34 [14%] vs 35 [15%]; OR 1.01，95% CI 0.61-1.69，p=0.96）。研究药物通常耐受良好;最常见的不良事件是便秘（安慰剂组14例[6%] vs艾司西酞普兰组14例[6%]）、肌肉疼痛（16例[7%] vs 10例[4%]）和失眠（12例[5%] vs 12例[5%]）。腹泻在艾司西酞普兰组（9例[4%]患者）比安慰剂组（2例[1%]患者）更常见。解释艾司西酞普兰没有显著减少急性卒中患者的中度或重度抑郁症状。
Background Mood and emotional disturbances are common in patients with stroke, and adversely affect the clinical outcome. We aimed to evaluate the efficacy of early administration of escitalopram to reduce moderate or severe depressive symptoms and improve emotional and neurological dysfunction in patients with stroke.Methods This was a placebo controlled, double-blind trial done at 17 centres in South Korea. Patients who had had an acute stroke within the past 21 days were randomly assigned in a 1:1 ratio to receive oral escitalopram (10 mg/day) or placebo for 3 months. Randomisation was done with permuted blocks stratified by centre, via a web-based system. The primary endpoint was the frequency of moderate or severe depressive symptoms (Montgomery-Asberg Depression Rating Scale [MADRS] >= 16). Endpoints were assessed at 3 months after randomisation in the full analysis set (patients who took study medication and underwent assessment of primary endpoint after randomisation), in all patients who were enrolled and randomly assigned (intention to treat), and in all patients who completed the trial (per-protocol analysis). This trial is registered with ClinicalTrials.gov, number NCT01278498.Findings Between Jan 27, 2011, and June 30, 2014, 478 patients were assigned to placebo (n=237) or escitalopram (n=241); 405 were included in the full analysis set (195 in the placebo group, 210 in the escitalopram group). The primary outcome did not differ by study group in the full analysis set (25 [13%] patients in the placebo group vs 27 [13%] in the escitalopram group; odds ratio [OR] 1.00, 95% CI 0.56-1.80; p>0.99) or in the intention-to-treat analysis (34 [14%] vs 35 [15%]; OR 1.01, 95% CI 0.61-1.69, p=0.96). The study medication was generally well tolerated; the most common adverse events were constipation (14 [6%] patients who received placebo vs 14 [6%] who received escitalopram), muscle pain (16 [7%] vs ten [4%]), and insomnia (12 [5%] vs 12 [5%]). Diarrhoea was more common in the escitalopram group (nine [4%] patients) than in the placebo group (two [1%] patients).Interpretation Escitalopram did not significantly reduce moderate or severe depressive symptoms in patients with acute stroke.