Effect of montelukast on remission maintenance in patients with ulcerative colitis: a Randomized, double-blind controlled clinical trial.

IF 2.5 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Kourosh Masnadi Shirazi, Mehran Nezam Diba, Arman Masnadi Shirazinezhad, Zeinab Nikniaz
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Abstract

Background: Considering the role of leukotrienes in inflammatory pathways, and owing to the anti-leukotrienes effect of montelukast, in the present clinical trial, we aimed to assess the effect of montelukast on remission maintenance in patients with ulcerative colitis (UC).

Methods: In the present double-blind randomized controlled clinical trial, 222 volunteer UC patients on high-dose corticosteroid and montelukast were recruited. The patients received 10 mg of montelukast (98 patients) or placebo (124 patients) for 22 weeks. Simultaneously, the prednisolone dose was tapered. The patients were followed up eight more weeks post-interventions. The primary efficacy of the treatment was remaining in remission.

Results: 194 patients completed this study. During the study, relapse occurred in 108 patients, 32 patients in the montelukast group and 76 patients in the placebo group. There were significant differences between groups regarding the relapse-free period (intervention group mean: 27.25 95% CI: 26.17-28.32 weeks and placebo group mean: 20.88; 95% CI: 19.36, 20.40 weeks, P < 0.001). At the end of the intervention period and six weeks' post-intervention, the mean partial Mayo score, and inflammatory biomarkers were significantly lower in the montelukast group compared with the placebo group. The frequency of patients with high fecal calprotectin levels was significantly higher in the placebo group compared with the montelukast Group.

Conclusion: The findings indicated that compared with placebo, montelukast had a significant positive effect on remission maintenance in UC patients who were in the steroid-tapering phase of therapy.

Clinical trial registration number: IRCT20121212011738N3.

孟鲁司特对溃疡性结肠炎患者缓解维持的影响:一项随机、双盲对照临床试验。
背景:考虑到白三烯在炎症通路中的作用,以及孟鲁司特的抗白三烯作用,在本临床试验中,我们旨在评估孟鲁司特对溃疡性结肠炎(UC)患者缓解维持的影响。方法:采用双盲随机对照临床试验,招募222例自愿接受大剂量皮质类固醇联合孟鲁司特治疗的UC患者。患者接受10mg孟鲁司特(98例)或安慰剂(124例)治疗22周。同时,泼尼松龙剂量逐渐减少。这些患者在干预后接受了8周的随访。治疗的主要疗效是保持缓解。结果:194例患者完成本研究。在研究期间,108例患者复发,孟鲁司特组32例,安慰剂组76例。两组无复发期差异有统计学意义(干预组平均:27.25,95% CI: 26.17-28.32周,安慰剂组平均:20.88周;95% CI: 19.36, 20.40周,P结论:研究结果表明,与安慰剂相比,孟鲁司特对处于类固醇减量治疗期的UC患者的缓解维持有显著的积极作用。临床试验注册号:IRCT20121212011738N3。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMC Gastroenterology
BMC Gastroenterology 医学-胃肠肝病学
CiteScore
4.20
自引率
0.00%
发文量
465
审稿时长
6 months
期刊介绍: BMC Gastroenterology is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of gastrointestinal and hepatobiliary disorders, as well as related molecular genetics, pathophysiology, and epidemiology.
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