Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine
Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine
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DOI：
10.1111/j.1365-2982.2011.01771.x
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发表时间：
2011-12-01
影响因子：
3.5
通讯作者：
Rhee, P. L.
中科院分区：
文献类型：
--
作者：
Lee, K. J.;Kim, N. Y.;Rhee, P. L.
背景5-HT（3）受体拮抗剂是治疗肠易激综合征（IBS）的有效药物，但尚未得到广泛应用。本研究的目的是比较雷莫司琼（一种5-HT（3）受体拮抗剂）和美贝维林治疗男性IBS伴腹泻（IBS-D）患者的疗效和安全性。方法采用多中心、随机、开放设计。343例IBS-D男性患者随机接受雷莫司琼5 μ g每日1次治疗4周或美贝维林135 mg每日3次治疗4周，通过意向治疗分析对这些患者的数据进行分析。主要疗效参数是治疗最后一周IBS症状充分缓解的患者比例。次要终点是每个症状评分和安全性特征的变化。关键结果在治疗期间，雷莫司琼和美贝维林组的总体IBS症状、腹痛/不适和排便习惯异常的应答率显著增加。与基线相比，两个治疗组的腹痛/不适和尿急的严重程度评分、大便形态评分和大便频率均显著降低。雷莫司琼组和美贝维林组的应答率（ITT分析为37% vs 38%）和不良事件特征无显著差异。雷莫司琼治疗患者未报告重度便秘或缺血性结肠炎。结论与推论雷莫司琼5 μ g每日一次与美贝维林每日三次治疗IBS-D男性患者同样有效。
Background The 5-HT(3) receptor antagonists are known to be effective for the treatment of diarrhea-predominant irritable bowel syndrome (IBS), but not widely used yet. The aim of this study was to compare the efficacy and safety of ramosetron, a 5-HT(3) receptor antagonist, and mebeverine in male patients with IBS with diarrhea (IBS-D). Methods This study was performed in a multicenter, randomized, open-label design. Data of 343 male patients with IBS-D who were randomized to either a 4-week treatment of ramosetron 5 mu g once daily or a 4-week treatment of mebeverine 135 mg three times daily were analyzed by the intent-to-treat analysis. The primary efficacy parameter was the proportion of patients with adequate relief of IBS symptoms at the last week of treatment. The secondary endpoints were changes in each symptom score and the safety profiles. Key Results The responder rates for global IBS symptoms, abdominal pain/discomfort and abnormal bowel habits in the ramosetron and mebeverine groups significantly increased during the treatment period. The severity scores of abdominal pain/discomfort and urgency, the stool form score, and the stool frequency in both treatment arms were significantly reduced, compared with the baselines. There were no significant differences in the responder rates (37% vs 38% on ITT analysis) and adverse event profiles between the ramosetron and mebeverine groups. Neither severe constipation nor ischemic colitis was reported by ramosetron-treated patients. Conclusions & Inferences Ramosetron 5 mu g once daily is as effective as mebeverine three times daily in male patients with IBS-D.