Duloxetine in the treatment of irritable bowel syndrome: an open-label pilot study
Duloxetine in the treatment of irritable bowel syndrome: an open-label pilot study
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DOI：
10.1002/hup.1038
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发表时间：
2009-07-01
影响因子：
1.7
通讯作者：
Hudson, James I.
中科院分区：
文献类型：
--
作者：
Brennan, Brian P.;Fogarty, Kate V.;Hudson, James I.
目的评价度洛沙坦治疗肠易激综合征（IBS）的疗效。主要结果指标为平均腹痛。次要指标包括IBS症状、临床总体印象-严重程度、汉密尔顿焦虑评定量表、IBS生活质量量表和Sheehan残疾量表。我们使用随机回归和单样本t-tests.Results的变化进行了分析，14例患者完成了至少一个基线后评估，8完成了研究。度洛沙汀与疼痛、疾病严重程度、生活质量、稀便、工作和家庭残疾以及焦虑的显著改善相关（p < 0.05）。然而，度洛沙汀并未改善硬便。虽然我们没有发现严重的度洛沙坦毒性的证据，7名参与者退出了研究的过程中，因为药物不良事件。结论在这个小的，开放标签的研究，度洛沙坦似乎是有效的IBS的许多功能，但其不良反应，最显着的便秘，限制了其使用。由于我们的研究排除了伴有重度抑郁症的个体，看来度洛沙汀可能独立于其抗抑郁作用而有益于IBS。这些令人鼓舞但初步的开放标签研究结果支持在HIS安慰剂对照试验中进一步研究度洛西汀治疗。版权所有（C）2009约翰威利父子有限公司
Objective To assess the efficacy of duloxetine for irritable bowel syndrome (IBS).Methods We conducted an open-label 12-week trial of duloxetine 60 mg daily in 15 patients with IBS without concurrent major depressive disorder. The primary outcome measure was average abdominal pain. Secondary measures included IBS symptoms, Clinical Global Impression-Severity, Hamilton Anxiety Rating Scale, IBS Quality-of-Life Scale, and Sheehan Disability Scale. We analyzed changes using random regression and one-sample t-tests.Results Fourteen patients completed at least one post-baseline evaluation; eight completed the study. Duloxetine was associated with significant improvement (p < 0.05) in pain, severity of illness, quality of life, loose stool, work and family disability, and anxiety. However, duloxetine did not improve hard stool. Although we found no evidence of serious duloxetine toxicity, seven participants withdrew over the course of the study because of adverse drug events.Conclusions In this small, open-label study, duloxetine appeared to be effective for many features of IBS, but its adverse effects, most notably constipation, limited its use. Since our study excluded individuals with concurrent major depression, it appears that duloxetine may benefit IBS independently of its antidepressant effects. These encouraging but preliminary open-label findings support further investigation of duloxetine treatment in placebo-controlled trials of HIS. Copyright (C) 2009 John Wiley & Sons, Ltd.