医学
维多利祖马布
安慰剂
内科学
胃肠病学
己酮可可碱
不利影响
优势比
置信区间
外科
克罗恩病
疾病
病理
替代医学
作者
Shivali Berera,Stephanie Ioannou,Diana Morillo,Alejandro Mantero,Judith Pignac-Kobinger,Niurka Colina,Ana M. Santander,Irina Fernandez,Maria A. Quintero,Jennifer N. Rodriguez,David H. Kerman,Oriana M. Damas,Frank Czul,Daniel A. Sussman,Maria T. Abreu,Amar R. Deshpande
出处
期刊:Journal of Crohn's and Colitis
[Oxford University Press]
日期:2022-06-01
卷期号:16 (11): 1687-1695
被引量:1
标识
DOI:10.1093/ecco-jcc/jjac074
摘要
Abstract Background and Aims The efficacy of current biologics may be limited by targeting only one pathway. Pentoxifylline [PTX] interferes with tumour necrosis factor [TNF] gene expression. We performed a randomised, placebo-controlled pilot study to determine if PTX plus vedolizumab [VDZ] in patients with Crohn’s disease [CD] is safe and improves response compared with VDZ monotherapy. Methods Thirty adult patients with active CD were randomised to VDZ/PTX or VDZ/placebo and followed for 24 weeks. Endoscopic activity and inflammatory cytokines were measured at baseline and Week 24. Descriptive statistics were used to determine estimates of effect. Results Demographics were similar but baseline disease activity was higher in the VDZ/PTX group. There was no difference in clinical remission at Week 14 (60.0% vs 66.67%, odds ratio [OR] 0.76, 95% confidence interval [CI] 0.16, 3.51) or steroid-free clinical remission at Week 24 in patients receiving VDZ/PTX. Improved clinical response was noted in the VDZ/PTX group at Weeks 6, 14, and 24 [Week 6: 20% vs 6.67%, Week 14: 26.67% vs 6.67%, Week 24: 40% vs 20%]. The rate of endoscopic remission was similar between the groups [40% vs 33.33%], with a greater mean decrease in Simple Endoscopic Score-CD [SES-CD] and C-reactive protein [CRP] with VDZ/PTX [SES-CD -3.17 vs -0.15, CRP -5.56 vs 0.46]. An increase in serum TNF-α concentration was observed with VDZ/placebo group; PTX mitigated this effect. No serious adverse events occurred. Conclusions VDZ/PTX did not provide benefit over VDZ monotherapy in clinical or endoscopic remission but appeared to improve clinical response and was safe. These data should inform a fully powered study.
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