Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: A randomized, placebo-controlled phase II study
Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: A randomized, placebo-controlled phase II study
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DOI：
10.1111/nmo.13023
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发表时间：
2017-06-01
影响因子：
3.5
通讯作者：
Hongo, M.
中科院分区：
文献类型：
--
作者：
Fukudo, S.;Matsueda, K.;Hongo, M.
背景资料：以前的研究表明，5 μ g雷莫司琼，一种5-羟色胺（5-HT）-3受体拮抗剂，仅对伴有腹泻的肠易激综合征（IBS）（IBS-D）男性患者有效。我们假设，无论是剂量1.25，2.5，或5微克的雷莫司琼将是有效的IBS-D的女性患者。方法：这个随机，双盲，安慰剂对照，II期剂量探索性试验包括409名女性门诊IBS-D在日本治疗。在1周的基线期后，他们每天口服安慰剂（n=102）或1.25 μ g（n = 104），2.5 μ g（n=104）或5 μ g（n=99）雷莫司琼，持续12周。主要终点是第一个月IBS症状总体改善的每月应答率。次要终点包括其他月份的总体改善、腹痛/不适、布里斯托大便形态量表（BSFS）的每周平均变化和IBS-QOL。中剂量雷莫司琼（2.5 μ g）在第二个月显著改善了腹痛/不适（62.5%，P=.002），第三个月（60.6%，P=.005），最后一个评估点（63.5%，P=.002）和每周BSFS（P
Background: Previous studies showed that 5 mu g of ramosetron, a serotonin (5-hydroxytryptamine: 5-HT)-3 receptor antagonist, is only effective in male patients with irritable bowel syndrome (IBS) with diarrhea (IBS-D). We hypothesized that either dose 1.25, 2.5, or 5 mu g of ramosetron would be effective in female patients with IBS-D.Methods: This randomized, double-blind, placebo-controlled, phase II dose-finding exploratory trial included 409 female outpatients with IBS-D treated in Japan. They were administered oral placebo (n=102), or 1.25 mu g (n=104), 2.5 mu g (n=104), or 5 mu g (n=99) of ramosetron once daily for 12 weeks after a 1-week baseline period. The primary endpoint was monthly responder rates of global improvement of IBS symptoms in the first month. Secondary endpoints included global improvement in the other months, abdominal pain/discomfort, weekly mean changes in the Bristol Stool Form Scale (BSFS), and IBS-QOL.Key Results: Middle dose (2.5 mu g) of ramosetron significantly improved abdominal pain/discomfort at second month (62.5%, P=.002), third month (60.6%, P=.005), and the last evaluation point (63.5%, P=.002) and weekly BSFS (P