Instituto Mexicano Del Seguro Social (IMSS) HGZ 2. Aguascalientes, México Av. De Los Conos 102, Fraccionamiento Ojo Caliente, Desarrollo Especial Ojocaliente, Aguascalientes, 20190, Mexico.
Hospital De Alta Especialidad "Dr. Juan Graham Casasus", Calle Uno S/N, Miguel Hidalgo III Etapa, 86126, Villahermosa, Tabasco, México.
Clin Neurol Neurosurg. 2020 Mar;190:105656. doi: 10.1016/j.clineuro.2019.105656. Epub 2019 Dec 28.
Acute intracerebral hemorrhage (ICH) is a very common cause of disability. Previous evidence suggests that fluoxetine and other selective serotonin reuptake inhibitors improve, the recovery of motor function in patients with cerebral infarct. The purpose of this study was to investigate whether fluoxetine also improves motor recovery in patients with ICH.
This is a double blind, placebo controlled, multicenter randomized trial, patients recruited from three centers were assigned to receive 20 mg/day of fluoxetine or matching placebo for three months from within ten days after onset of symptoms. Primary outcome was change in Fugl-Meyer Motor Scale from baseline to day 90.
Thirty patients (50 % women) were recruited to the fluoxetine (n = 14) or placebo (n = 16) groups. Median age was 55 years, the cause of the ICH was hypertension in 93.3 %, median volume of the hematomas was 22mm. Basal ganglia hematoma was present in 67 % and, lobar location in 20 % of the patients. Improvement in FMMS at day 90 was significatively higher in the treatment group (median score 23) than in the placebo group, (median score 48), p = 0.001. No serious adverse events occurred.
In addition to standard treatment, early prescription of fluoxetine was safe and helped to increase motor recovery 90 days after ICH. This finding adds to the evidence regarding its beneficial effect upon stroke related disability. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01737541.
急性脑出血（ICH）是一种非常常见的致残原因。先前的证据表明，氟西汀和其他选择性 5-羟色胺再摄取抑制剂可改善脑梗死患者的运动功能恢复。本研究旨在探讨氟西汀是否也能改善 ICH 患者的运动功能恢复。
这是一项双盲、安慰剂对照、多中心随机试验，从三个中心招募的患者被分配接受氟西汀 20mg/天或匹配的安慰剂治疗，为期三个月，从症状出现后十天内开始。主要结局是从基线到第 90 天 Fugl-Meyer 运动量表的变化。
30 名患者（50%为女性）被纳入氟西汀（n=14）或安慰剂（n=16）组。中位年龄为 55 岁，ICH 的病因是高血压占 93.3%，血肿中位数为 22mm。基底节血肿占 67%，叶状部位占 20%。治疗组（中位评分 23）在第 90 天时 FMMS 的改善明显高于安慰剂组（中位评分 48），p=0.001。未发生严重不良事件。
除了标准治疗外，早期开具氟西汀处方是安全的，并有助于在 ICH 后 90 天增加运动恢复。这一发现增加了关于其对中风相关残疾有益作用的证据。临床试验注册网址：http://www.clinicaltrials.gov。独特标识符：NCT01737541。
