Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof-of-concept study
Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof-of-concept study
复制标题
DOI：
10.1111/j.1365-2036.2009.04041.x
复制
发表时间：
2009-08-01
影响因子：
7.6
通讯作者：
Barbara, G.
中科院分区：
文献类型：
--
作者：
Corinaldesi, R.;Stanghellini, V.;Barbara, G.
肠道免疫浸润与肠易激综合征（IBS）患者的症状有关。目的通过一项初步研究，评估美沙拉嗪（美沙拉胺）对肠易激综合征患者粘膜免疫细胞的影响。方法对20例三级医疗机构IBS患者进行随机、双盲、安慰剂对照试验。患者随机接受安慰剂或800毫克美沙拉嗪，每天三次，持续8周。主要终点是与基线相比，治疗结束时获得的活检中结肠免疫细胞总数显着减少。次要终点包括对免疫细胞亚群、炎症介质和症状严重程度的影响。进行意向治疗分析。结果与安慰剂相比，美沙拉嗪显著减少免疫细胞（P = 0.0082）；这种效果归因于对肥大细胞的显著抑制（P = 0.0014）。美沙拉嗪显著提高了总体幸福感（P = 0.038），但对腹痛（P = 0.084）、腹胀（P = 0.177）或排便习惯没有显著影响。研究期间未报告严重的药物相关不良事件。结论美沙嗪是减少肥大细胞浸润的有效、安全的方法，可改善肠易激综合征患者的总体幸福感。这些结果支持了免疫机制代表肠易激综合征潜在治疗靶点的假设。
BackgroundIntestinal immune infiltration contributes to symptoms in patients with irritable bowel syndrome (IBS).AimTo assesses the effect of mesalazine (mesalamine) on mucosal immune cells in patients with IBS, through a pilot study.MethodsA randomized, double-blind, placebo-controlled trial in 20 patients with IBS in tertiary care setting. Patients were randomized to receive placebo or 800 mg mesalazine three times daily for 8 weeks. The primary endpoint was a significant reduction in total colonic immune cells on biopsies obtained at the end of treatment compared to baseline. Secondary endpoints included effects on subsets of immune cells, inflammatory mediators and symptom severity. Intention-to-treat analysis was performed.ResultsMesalazine markedly reduced immune cells as compared with placebo (P = 0.0082); this effect was ascribed to a marked inhibition of mast cells (P = 0.0014). Mesalazine significantly increased general well-being (P = 0.038), but had no significant effects on abdominal pain (P = 0.084), bloating (P = 0.177) or bowel habits. No serious drug-related adverse events were reported during the study.ConclusionsMesalazine is an effective and safe approach to reduce mast cell infiltration and may improve general well-being in patients with IBS. These results support the hypothesis that immune mechanisms represent potential therapeutic targets in IBS.