Kim Jong S, Lee Eun-Jae, Chang Dae-Il, Park Jong-Ho, Ahn Seong Hwan, Cha Jae-Kwan, Heo Ji Hoe, Sohn Sung-Il, Lee Byung-Chul, Kim Dong-Eog, Kim Hahn Young, Kim Seongheon, Kwon Do-Young, Kim Jei, Seo Woo-Keun, Lee Jun, Park Sang-Won, Koh Seong-Ho, Kim Jin Young, Choi-Kwon Smi
Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, South Korea.
Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, South Korea.
Lancet Psychiatry. 2017 Jan;4(1):33-41. doi: 10.1016/S2215-0366(16)30417-5.
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.
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-Åsberg 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.
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).
Escitalopram did not significantly reduce moderate or severe depressive symptoms in patients with acute stroke.
Dong-A Pharmaceutical and Ministry for Health, Welfare, and Family Affairs, South Korea.
情绪和情感障碍在中风患者中很常见，并对临床结局产生不利影响。我们旨在评估早期给予艾司西酞普兰以减轻中度或重度抑郁症状并改善中风患者的情绪和神经功能障碍的疗效。
这是一项在韩国17个中心进行的安慰剂对照双盲试验。在过去21天内发生急性中风的患者按1:1比例随机分配，接受口服艾司西酞普兰（10毫克/天）或安慰剂，为期3个月。通过基于网络的系统，采用按中心分层的置换块进行随机分组。主要终点是中度或重度抑郁症状的发生率（蒙哥马利-艾斯伯格抑郁评定量表[MADRS]≥16）。在全分析集（服用研究药物并在随机分组后接受主要终点评估的患者）、所有入组并随机分配的患者（意向性分析）以及所有完成试验的患者（符合方案分析）中，在随机分组后3个月评估终点。该试验已在ClinicalTrials.gov注册，编号为NCT01278498。
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，研究组之间的主要结局无差异（安慰剂组25例[13%]患者 vs 艾司西酞普兰组27例[13%]患者；优势比[OR]1.00，95%置信区间0.56 - 1.80；p>0.99），在意向性分析中也无差异（34例[14%] vs 35例[15%]；OR 1.01，95%置信区间0.61 - 1.69，p = 0.96）。研究药物总体耐受性良好；最常见的不良事件是便秘（接受安慰剂的患者中有14例[六级] vs 接受艾司西酞普兰的患者中有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。
艾司西酞普兰并未显著减轻急性中风患者的中度或重度抑郁症状。
韩国东亚制药公司和韩国卫生、福利和家庭事务部。
