Mikocka-Walus Antonina, Hughes Patrick A, Bampton Peter, Gordon Andrea, Campaniello Melissa A, Mavrangelos Chris, Stewart Benjamin J, Esterman Adrian, Andrews Jane M
School of Nursing and Midwifery, University of South Australia, Adelaide, Australia.
Department of Health Sciences, University of York, York, UK.
J Crohns Colitis. 2017 Apr 1;11(4):509-514. doi: 10.1093/ecco-jcc/jjw165.
Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease [CD] maintained remission, improved quality of life [QoL] and/or mental health in people with CD as compared to placebo.
A parallel randomized double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20 mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and completed mental health and QoL questionnaires. Immune functions were assessed by stimulated cytokine secretion [CD3/CD28 stimulation] and flow cytometry for cell type. Linear mixed-effects models were used to compare groups.
Of the 26 participants, 14 were randomized to receive fluoxetine and 12 to placebo. Overall, 14 [54%] participants were male. The mean age was 37.4 [SD=13.2] years. Fluoxetine had no effect on inflammatory bowel disease activity measured using either the Crohn's Disease Activity Index [F(3, 27.5)=0.064, p=0.978] or faecal calprotectin [F(3, 32.5)=1.08, p=0.371], but did have modest effects on immune function. There was no effect of fluoxetine on physical, psychological, social or environmental QoL, anxiety or depressive symptoms as compared to placebo [all p>0.05].
In this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL. [ID: ACTRN12612001067864.].
既往研究表明，抗抑郁药可减轻结肠炎动物模型中的炎症。本试验旨在研究与安慰剂相比，在克罗恩病（CD）标准治疗方案中加用氟西汀是否能维持缓解、改善生活质量（QoL）和/或心理健康。
进行了一项平行随机双盲安慰剂对照试验。临床确诊为CD且病情静止或仅为轻度的参与者被随机分配，分别每日服用20mg氟西汀或安慰剂，并随访12个月。参与者提供血液和粪便样本，并完成心理健康和QoL问卷。通过刺激细胞因子分泌（CD3/CD28刺激）和流式细胞术检测细胞类型来评估免疫功能。使用线性混合效应模型对组间进行比较。
26名参与者中，14名被随机分配接受氟西汀治疗，12名接受安慰剂治疗。总体而言，14名（54%）参与者为男性。平均年龄为37.4（标准差=13.2）岁。氟西汀对使用克罗恩病活动指数（F(3, 27.5)=0.064，p=0.978）或粪便钙卫蛋白（F(3, 32.5)=1.08，p=0.371）测量的炎症性肠病活动无影响，但对免疫功能有适度影响。与安慰剂相比，氟西汀对身体、心理、社会或环境QoL、焦虑或抑郁症状均无影响（所有p>0.05）。
在这项小型先导性临床试验中，氟西汀在维持缓解或改善QoL方面并不优于安慰剂。[试验注册号：ACTRN12612001067864。]
