Department of Pharmacy Practice, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Ann Pharmacother. 2011 Sep;45(9):1061-6. doi: 10.1345/aph.1Q219. Epub 2011 Aug 18.
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.
To evaluate the effectiveness of lubiprostone for the treatment of constipation in adults with CF.
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 μg 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.
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/m², 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.
Lubiprostone may be an effective option for the treatment of constipation in adults with CF.
便秘在囊性纤维化（CF）人群中很常见，但目前用于治疗便秘的方法效果数据很少。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 CF 相关的便秘可能特别有效。
评估鲁比前列酮治疗 CF 成人便秘的疗效。
在这项初步研究中，参与者充当自己的对照，在入组期和治疗期之间进行比较。在为期 2 周的入组期内，参与者继续使用常规治疗便秘的方法；在为期 4 周的治疗期内，参与者接受鲁比前列酮 24μg，每日两次。疗效指标包括自发排便频率、布里斯托大便量表评分和患者便秘症状评估量表（PAC-SYM）评分。在入组期和治疗期（治疗 0、2 和 4 周）都评估了结局。安全性指标包括肺活量测定、体重和血清化学。
7 名参与者完成了这项研究。平均（SD）基线 1 秒用力呼气量为预计值的 83.0%（9.4），体重指数为 24.0（2.8）kg/m²，表明这是一组总体健康、营养状况良好的 CF 成年患者。鲁比前列酮改善了 PAC-SYM 调查评分所评估的便秘总体症状（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量表评分在各期间无统计学差异。安全性指标无差异。2 名参与者分别报告出现一过性胸闷和呼吸急促，但没有参与者因这些不良反应而退出。
鲁比前列酮可能是 CF 成人便秘治疗的有效选择。
