FLUORESCE: A pilot randomized clinical trial of fluoxetine for vision recovery after acute ischemic stroke

Background and purpose: Post-stroke homonymous hemianopia is disabling and complete spontaneous recovery is rare. In this randomized, double-blind, placebo-controlled pilot clinical trial, we tested whether fluoxetine enhances vision recovery after stroke. <br>Methods: We randomized 17 consecutive adults 1:1 to 90 days of fluoxetine 20 mg daily vs. placebo within 10 days of an ischemic stroke causing homonymous hemianopia. The primary endpoint was percent improvement in 24-2 Humphrey perimetry at six months. Twelve participants completed the study. <br>Results: Intention-to-treat analysis of the primary endpoint, percent improvement in perimetric mean deviation, showed a non-significant benefit of fluoxetine (64.4%, n=5) over placebo (26.0%, n=7, 95% confidence interval (CI)=(-2.13,∞), p=0.06). The original blind field completely recovered in 60% receiving fluoxetine and 14% receiving placebo (odds ratio=7.22, 95%CI=(0.50,∞)).<br>Conclusions: These results suggest a trend in favor of fluoxetine and should be followed up with a multi-center trial. <br>Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02737930<br>

研究背景与目的：卒中后同侧偏盲（homonymous hemianopia）会导致患者出现严重功能残疾，且完全自发恢复的情况极为罕见。本项随机、双盲、安慰剂对照的先导临床试验，旨在评估氟西汀是否能够促进卒中后视觉功能的恢复。
研究方法：本研究将17例因缺血性卒中引发同侧偏盲的连续入组成年患者，以1:1的比例随机分为两组，分别接受为期90天的每日20mg氟西汀或安慰剂治疗，入组时间需在卒中发作后10天以内。本研究的主要终点为治疗6个月时，24-2型Humphrey视野计（Humphrey perimetry）检测结果的改善百分比。最终共有12名受试者完成了本项研究。
研究结果：针对主要终点的意向性治疗分析（intention-to-treat analysis）显示，氟西汀组（64.4%，n=5）在视野计平均偏差值改善率上较安慰剂组（26.0%，n=7）呈现出非显著性获益，其95%置信区间（CI）为(-2.13, +∞)，p=0.06。氟西汀组中有60%的患者原始暗点完全恢复，安慰剂组这一比例为14%，比值比（odds ratio）为7.22，95%CI=(0.50, +∞)。
研究结论：本研究结果显示氟西汀具有促进视觉恢复的趋势，未来需开展多中心临床试验进行进一步验证。
临床试验注册：网址：http://www.clinicaltrials.gov，唯一识别编号：NCT02737930