A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D).
A mechanistic multicentre, parallel group, randomised placebo-controlled trial of mesalazine for the treatment of IBS with diarrhoea (IBS-D).
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DOI：
10.1136/gutjnl-2015-309122
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发表时间：
2016-01
期刊：
影响因子：
24.5
通讯作者：
Spiller R
中科院分区：
文献类型：
--
作者：
Lam C;Tan W;Leighton M;Hastings M;Lingaya M;Falcone Y;Zhou X;Xu L;Whorwell P;Walls AF;Zaitoun A;Montgomery A;Spiller R
据报道，肠易激综合征合并腹泻（IBS- d）患者的粘膜中存在免疫激活，一些小型研究表明美萨拉嗪可能减轻症状。我们对罗马III型标准IBS-D患者进行了一项双盲、随机安慰剂对照试验，每天两次使用2g美沙拉嗪与安慰剂对照，持续3个月。主要终点是11-12周的每日平均大便频率；次要结局是腹痛、大便一致性、急症和IBS症状的满意缓解。参与者在2周的基线粪便日记后随机分组。所有参与者都完成了为期12周的粪便日记，并在每周结束时记录“肠易激综合征症状的满意缓解”。136例IBS-D患者（女性82例，男性54例）被随机分组，每组退出10例。意向治疗分析显示，第11周和第12周，美沙拉嗪组每日平均大便次数为2.8（1.2）次，安慰剂组为2.7（1.9）次，组间无显著差异，（95% CI） 0.1 (- 0.33 ~ 0.53), p=0.66。在最后两周的随访中，与安慰剂相比，美沙拉嗪没有改善腹痛、大便一致性和满意缓解的百分比。本研究不支持在未选择的IBS-D患者中，美沙拉嗪与安慰剂相比有任何临床意义的益处或危害。需要基于潜在疾病机制的更精确的亚型，以便更有效地靶向治疗肠易激综合征。NCT01316718。
Immune activation has been reported in the mucosa of IBS patients with diarrhoea (IBS-D), and some small studies have suggested that mesalazine may reduce symptoms. We performed a double-blind, randomised placebo-controlled trial of 2 g mesalazine twice daily versus placebo for 3 months in patients with Rome III criteria IBS-D. Primary outcome was daily average stool frequency during weeks 11–12; secondary outcomes were abdominal pain, stool consistency, urgency and satisfactory relief of IBS symptoms. Participants were randomised after a 2-week baseline stool diary. All participants completed a 12-week stool diary and at the end of each week recorded the presence of ‘satisfactory relief of IBS symptoms’. 136 patients with IBS-D (82 women, 54 men) were randomised, 10 patients withdrew from each group. Analysis by intention to treat showed the daily average stool frequency during weeks 11 and 12 were mean (SD), 2.8 (1.2) in mesalazine and 2.7 (1.9) in the placebo group with no significant group difference, (95% CI) 0.1 (−0.33 to 0.53), p=0.66. Mesalazine did not improve abdominal pain, stool consistency nor percentage with satisfactory relief compared with placebo during the last two-weeks follow-up. This study does not support any clinically meaningful benefit or harm of mesalazine compared with placebo in unselected patients with IBS-D. More precise subtyping based on underlying disease mechanisms is needed to allow more effective targeting of treatment in IBS. NCT01316718.