French Reference Center for MSA, Centre d'Investigation Clinique de Toulouse CIC1436, Departments of Neurosciences and Clinical Pharmacology, NS-Park/FCRIN Network, NeuroToul COEN Center, University Hospital of Toulouse, INSERM, University of Toulouse 3, Toulouse, France.
Department of Neurology, Beau Soleil Clinic, Montpellier, France.
Mov Disord. 2021 Jul;36(7):1704-1711. doi: 10.1002/mds.28569. Epub 2021 Apr 1.
There are no effective treatments for multiple system atrophy (MSA).
The objective of this study was to assess the efficacy and safety of the serotonin reuptake inhibitor fluoxetine (40 mg/d) for the symptomatic treatment of MSA.
This was a double-blind, parallel-group, placebo-controlled, randomized trial in patients with "probable" MSA. The primary outcome was the change from baseline to week 12 in the mean total score of the Unified MSA Rating Scale (UMSARS Parts I + II). Secondary outcomes included change from baseline to week 6 in total UMSARS, and change from baseline to week 12 in the Scales for Outcomes in Parkinson Disease-Autonomic Dysfunction, Beck Depression Inventory, and different domains of the MSA-Quality of Life Questionnaire. Exploratory outcomes included change from baseline to week 12 in the UMSARS Parts I and II separately and change from baseline to week 24 in the total UMSARS score.
A total of 81 patients were randomly assigned, with no significant difference in the primary outcome (-2.13 units [95% confidence interval, CI, -4.55 to 0.29]; P = 0.08). There was a greater reduction on fluoxetine in the change from baseline to 12-week in UMSARS Part II (exploratory outcome: -1.41 units [95% CI, -2.84; 0.03]; p = 0.05) and in MSA-QoL emotional/social dimension (secondary outcome: -6.99 units [95% CI, -13.40; -0.56]; p < 0.03). A total of 5 deaths occurred (3 on fluoxetine and 2 on placebo).
The MSA-FLUO failed to demonstrate fluoxetine superiority over placebo on the total UMSARS score, whereas trends in motor and emotional secondary/exploratory outcomes deserve further investigation. © 2021 International Parkinson and Movement Disorder Society.
目前对于多系统萎缩症（MSA）尚无有效的治疗方法。
本研究旨在评估选择性 5-羟色胺再摄取抑制剂氟西汀（40mg/d）对 MSA 症状治疗的疗效和安全性。
这是一项在“可能”患有 MSA 的患者中进行的双盲、平行组、安慰剂对照、随机临床试验。主要结局是从基线到第 12 周时统一 MSA 评定量表（UMSARS 部分 I+II）的总评分均值变化。次要结局包括从基线到第 6 周的 UMSARS 总分变化，以及从基线到第 12 周的帕金森病自主功能障碍评定量表、贝克抑郁量表和 MSA 生活质量问卷不同领域的变化。探索性结局包括从基线到第 12 周 UMSARS 部分 I 和 II 以及从基线到第 24 周 UMSARS 总分的变化。
共有 81 例患者被随机分配，主要结局无显著差异（-2.13 个单位[95%置信区间，CI，-4.55 至 0.29]；P=0.08）。在氟西汀组中，UMSARS 第 II 部分的变化从基线到 12 周时（探索性结局：-1.41 个单位[95%CI，-2.84；0.03]；p=0.05）和 MSA-QoL 情绪/社交维度（次要结局：-6.99 个单位[95%CI，-13.40；-0.56]；p<0.03）的降幅更大。共有 5 例死亡（氟西汀组 3 例，安慰剂组 2 例）。
MSA-FLUO 未能证明氟西汀在 UMSARS 总分上优于安慰剂，而在运动和情绪次要/探索性结局方面的趋势值得进一步研究。© 2021 国际帕金森病和运动障碍学会。
