Lubiprostone for Constipation in Adults with Cystic Fibrosis: A Pilot Study
Lubiprostone for Constipation in Adults with Cystic Fibrosis: A Pilot Study
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DOI：
10.1345/aph.1q219
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发表时间：
2011-09-01
影响因子：
2.9
通讯作者：
Stowe, Cindy D.
中科院分区：
文献类型：
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作者：
O'Brien, Catherine E.;Anderson, Paula J.;Stowe, Cindy D.
背景：便秘在囊性纤维化（CF）人群中普遍存在，但很少有数据表明目前使用的治疗方法的有效性。鲁比前列酮是一种泻药，通过激活胃肠道中的2型氯离子通道起作用，因此对于与CF相关的便秘可能特别有效。
目的：评估鲁比前列酮治疗成人CF便秘的有效性。
方法：在这项初步研究中，参与者作为自身对照，对导入期和治疗期进行比较。在2周的导入期内，参与者继续其常规的便秘治疗；在4周的治疗期内，参与者每日两次接受24微克鲁比前列酮。疗效结果包括自发排便频率、布里斯托大便性状评分以及便秘症状患者评估（PAC - SYM）调查评分。在导入期和治疗期（治疗0、2和4周）对结果进行评估。安全性结果包括肺功能测定、体重和血清化学指标。
结果：7名参与者完成了研究。平均（标准差）基线第1秒用力呼气量为预测值的83.0%（9.4），体重指数为24.0（2.8）千克/平方米，表明这是一组总体健康、营养良好的成人CF患者。通过PAC - SYM调查评分衡量，鲁比前列酮改善了便秘的总体症状（在0、2和4周时分别为1.18[0.56]、0.54[0.27]和0.44[0.36]；P < 0.001）。自发排便频率和布里斯托大便性状评分在各期间无统计学显著差异。安全性指标无差异。有2名不同的参与者报告了短暂的胸闷和呼吸急促，但均未因这些不良反应而退出。
结论：鲁比前列酮可能是治疗成人CF便秘的一种有效选择。
BACKGROUND: Constipation is prevalent in the cystic fibrosis (CF) population and yet there are few data demonstrating the effectiveness of currently used treatments. Lubiprostone is a laxative that works by activating the type 2 chloride channel in the gastrointestinal tract and thus has the potential to be especially effective for constipation associated with CF.OBJECTIVE: To evaluate the effectiveness of lubiprostone for the treatment of constipation in adults with CF.METHODS: In this pilot study, participants acted as their own controls and comparisons were made between run-in and treatment periods. During the 2-week run-in period, participants continued their usual treatment for constipation; during the 4-week treatment period, participants received lubiprostone 24 mu g twice daily. Efficacy outcomes included spontaneous bowel movement frequency, Bristol Stool Scale scores, and Patient Assessment of Constipation Symptoms (PAC-SYM) survey scores. Outcomes were assessed during both the run-in and treatment periods (0, 2, and 4 weeks of treatment). Safety outcomes included spirometry, body weight, and serum chemistry.RESULTS: Seven participants completed the study. Mean (SD) baseline forced expiratory volume in 1 second was 83.0% (9.4) of predicted and body mass index was 24.0 (2.8) kg/m(2), indicating an overall healthy, well-nourished group of adults with CF. Lubiprostone improved overall symptoms of constipation as measured by PAC-SYM survey scores (1.18 [0.56], 0.54 [0.27], and 0.44 [0.36] at 0, 2, and 4 weeks, respectively; p < 0.001). Spontaneous bowel movement frequency and Bristol Stool Scale scores were not statistically significantly different between periods. There were no differences in safety measures. Transient chest tightness and shortness of breath were reported by 2 separate participants, although neither participant withdrew due to these adverse effects.CONCLUSIONS: Lubiprostone may be an effective option for the treatment of constipation in adults with CF.