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首页> 外文期刊>Therapeutic advances in gastroenterology. >Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint
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Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint

机译：Alosetron在临床实践中的使用：使用美国食品药品监督管理局综合终点评估的肠易激综合症症状得到显着改善

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Alosetron is approved to treat women with severe IBS and diarrhea (IBS-D) who have failed standard therapy. In our study, we aimed to evaluate alosetron efficacy using new US Food and Drug Administration (FDA) endpoints and utilization in clinical practice. This prospective, open-label, multicenter, observational 12-week study evaluated women with severe IBS-D enrolled in the alosetron prescribing program. The coprimary FDA endpoints were changes from baseline in stool consistency and abdominal pain severity. Responders achieved a 30% decrease compared with baseline in weekly average of the worst abdominal pain in the past 24 h, and a 50% or greater reduction from baseline in the number of days/week with at least one stool of type 6 (mushy) or type 7 (watery) consistency. Secondary endpoints included changes from baseline in stool frequency, fecal urgency and fecal incontinence. Enrolled patients (n = 192) were primarily White (90.6%), with a mean age of 44.5 years. Patient and physician rating of IBS severity was between moderate and severe (85.9% concordance, Spearman coefficient 0.429, p < 0.0001). Alosetron 0.5 mg twice daily (82.8%) was the most common dosing regimen. A total of 152 alosetron-treated patients completed the study. Of 105 fully evaluable patients, 45% met the FDA composite endpoint responder criteria for ?50% of the study period. Improvements in all individual symptoms were statistically significant compared with baseline. There were no serious adverse events, cases of colonic ischemia, or complications of constipation. In a clinical practice setting study, alosetron demonstrated treatment success using a rigorous FDA composite endpoint and also improved multiple other IBS symptoms, including fecal urgency and incontinence in women with severe IBS-D [ ClinicalTrials.gov identifier: NCT01257477].
机译：Alosetron被批准用于治疗标准治疗失败的重度IBS和腹泻（IBS-D）妇女。在我们的研究中，我们旨在使用美国食品和药物管理局（FDA）的新终点评估阿洛司琼的疗效，并在临床实践中加以利用。这项前瞻性，开放标签，多中心，观察性的12周研究评估了参加Alosetron处方计划的患有严重IBS-D的女性。 FDA的主要共同点是粪便稠度和腹痛严重程度相对于基线的变化。在过去的24小时内，最坏的腹部疼痛的每周平均水平，与基线相比，响应者减少了30％;对于至少一个6型（糊状）大便，天/周的响应天数比基线减少了50％或更多或7型（水性）一致性。次要终点包括大便次数，粪便尿急和大便失禁的基线变化。入组患者（n = 192）主要是白人（90.6％），平均年龄为44.5岁。 IBS严重程度的患者和医师评分介于中度和严重之间（一致性为85.9％，Spearman系数为0.429，p <0.0001）。最常见的给药方案是每日两次0.5 mg阿洛司琼（82.8％）。共有152名用阿洛司琼治疗的患者完成了该研究。在105名完全可评估的患者中，有45％的患者在研究期间符合FDA复合终点应答者标准的50％。与基线相比，所有个体症状的改善均具有统计学意义。没有严重的不良事件，结肠缺血或便秘并发症。在一项临床实践研究中，阿洛司琼证明了使用严格的FDA复合终点治疗的成功，并且还改善了其他IBS症状，包括重度IBS-D妇女的尿急和尿失禁[ClinicalTrials.gov标识符：NCT01257477]。

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