Malagelada Carolina, Nieto Adoración, Mendez Sara, Accarino Anna, Santos Javier, Malagelada Juan-R, Azpiroz Fernando
Digestive System Research Unit, University Hospital Vall d'Hebron, Barcelona, Spain.
Center for Biomedical Research in the Network of Liver and Digestive Diseases, Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain.
J Gastroenterol Hepatol. 2017 Aug;32(8):1457-1462. doi: 10.1111/jgh.13733.
Patients with functional bowel disorders develop gas retention and symptoms in response to intestinal gas loads that are well tolerated by healthy subjects. Stimulation of 5HT-4 receptors in the gut has both prokinetic and antinociceptive effects. The aim of this study is to determine the effect of prucalopride, a highly selective 5HT-4 agonist, on gas transit and tolerance in women with functional bowel disorders complaining of constipation.
Twenty-four women with functional bowel disorders complaining of constipation were included in the study. Patients were studied twice on separate days in a cross-over design. On each study day, an intestinal gas challenge test was performed. During the five previous days, prucalopride (2 mg/day) or placebo was administered. Abdominal symptoms, stool frequency, and stool consistency were recorded during the treatment period on daily questionnaires.
During the gas challenge test, prucalopride did not decrease the volume of gas retained in the subset of patients who had significant gas retention (≥ 200 mL) while on placebo. However, in those patients who had increased symptoms during the gas test (≥ 3 on a 0 to 6 scale) when on placebo, prucalopride did significantly reduce the perception of symptoms (2.3 ± 0.5 mean score vs 3.5 ± 0.3 on placebo; P = 0.045). During the treatment period with prucalopride, patients exhibited an increase in the total number of bowel movements and decreased stool consistency compared with placebo.
Prucalopride reduces abdominal symptoms without modifying gas retention when patients with functional bowel disorders are challenged with the gas transit and tolerance test. European Clinical Trials Database (EudraCT2011-006354-86).
功能性肠病患者在面对健康受试者能够良好耐受的肠道气体负荷时，会出现气体潴留及相关症状。刺激肠道中的5HT - 4受体具有促动力和抗伤害感受作用。本研究旨在确定一种高选择性5HT - 4激动剂普芦卡必利对主诉便秘的功能性肠病女性患者气体转运及耐受性的影响。
本研究纳入了24名主诉便秘的功能性肠病女性患者。患者在不同日期接受两次交叉设计研究。在每次研究日，进行肠道气体激发试验。在之前的五天里，给予普芦卡必利（2毫克/天）或安慰剂。在治疗期间，通过每日问卷记录腹部症状、排便频率和大便稠度。
在气体激发试验期间，对于在服用安慰剂时存在显著气体潴留（≥200毫升）的患者亚组，普芦卡必利并未减少潴留气体的量。然而，对于在服用安慰剂时气体试验期间症状加重（0至6分制中≥3分）的患者，普芦卡必利确实显著降低了症状感知（平均得分2.3±0.5，而安慰剂组为3.5±0.3；P = 0.045）。与安慰剂相比，在使用普芦卡必利治疗期间，患者的排便总数增加，大便稠度降低。
当对功能性肠病患者进行气体转运及耐受性试验时，普芦卡必利可减轻腹部症状，但不改变气体潴留情况。欧洲临床试验数据库（EudraCT2011 - 006354 - 86）。
