Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome - results of two randomized, placebo-controlled studies
Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome - results of two randomized, placebo-controlled studies
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DOI：
10.1111/j.1365-2036.2008.03881.x
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发表时间：
2009-02-01
影响因子：
7.6
通讯作者：
Ueno, R.
中科院分区：
文献类型：
--
作者：
Drossman, D. A.;Chey, W. D.;Ueno, R.
背景缺乏针对便秘型肠易激综合征 (IBS-C) 的有效治疗方法。目的评估鲁比前列酮治疗 IBS-C 的有效性和安全性。方法在两项 3 期随机试验中，对 1171 名罗马 II 诊断为 IBS-C 的患者进行联合分析，鲁比前列酮 8 mcg 与安慰剂每天两次，为期 12 周。使用平衡的七点李克特量表，范围从显着缓解（+ 3）到显着恶化（- 3），患者在电子日记中回答以下问题：“与您进入研究之前的感觉相比，您如何评价过去一周 IBS 症状的缓解？”。主要疗效终点是总体缓解者的百分比。 结果使用意向治疗分析并延续最后一次观察，与安慰剂治疗的患者相比，鲁比前列酮治疗的患者被认为总体缓解的比例显着更高（17.9% vs. 10.1%，P = 0.001）。接受鲁比前列酮治疗的患者报告的不良事件发生率与接受安慰剂治疗的患者相似。 结论 与接受安慰剂治疗的患者相比，接受鲁比前列酮 8 mcg 每日两次治疗的患者中，基于患者对 IBS-C 症状评估的总体反应者百分比显着改善。鲁比前列酮具有良好的耐受性和良好的安全性。
BackgroundEffective treatments for irritable bowel syndrome with constipation (IBS-C) are lacking.AimTo assess the efficacy and safety of lubiprostone in IBS-C.MethodsA combined analysis was performed among 1171 patients with a Rome II diagnosis of IBS-C in two phase-3 randomized trials of lubiprostone 8 mcg vs. placebo twice daily for 12 weeks. Using a balanced seven-point Likert scale ranging from significantly relieved (+ 3), to significantly worse (- 3), patients responded on their electronic diary to the question: ;How would you rate your relief of IBS symptoms over the past week compared to how you felt before you entered the study?'. The primary efficacy endpoint was the percentage of overall responders.ResultsUsing an intent-to-treat analysis with last observation carried forward, a significantly higher percentage of lubiprostone-treated patients were considered overall responders compared with those treated with placebo (17.9% vs. 10.1%, P = 0.001). Patients treated with lubiprostone reported a similar incidence of adverse events to those treated with placebo.ConclusionsThe percentage of overall responders based on patient-rated assessments of IBS-C symptoms was significantly improved in patients treated with lubiprostone 8 mcg twice daily compared to those treated with placebo. Lubiprostone was well tolerated with a favourable safety profile.