| |
著者: A M George, N L Meyers, R I Hickling
雑誌名: Aliment Pharmacol Ther. 2008 May;27(9):830-7. doi: 10.1111/j.1365-2036.2008.03649.x. Epub 2008 Feb 14.
Abstract/Text
BACKGROUND: Relatively few pharmacological treatment options are available for treating patients with irritable bowel syndrome. New and effective medicines are urgently required.
AIM: To identify an appropriate dosage of renzapride (a 5-HT(4) receptor full agonist/5-HT(3) receptor antagonist) to treat abdominal pain/discomfort in patients with constipation-predominant irritable bowel syndrome.
METHODS: In this randomized, placebo-controlled, phase IIb study in the primary care setting, men and women were randomized to placebo or renzapride (1, 2 or 4 mg/day) for 12 weeks. The primary outcome measure was patient self-assessed relief of abdominal pain/discomfort during weeks 5-12. Secondary efficacy measures included patients' assessment of their bowel habits, stool consistency and quality of life.
RESULTS: Although there were no statistically significant differences between renzapride and placebo for relief from abdominal pain/discomfort, responder rates in the renzapride treatment groups increased dose dependently, with the 4 mg/day group being consistently numerically greater than placebo. Importantly, a larger numerical treatment difference vs. placebo was observed in women (8% and 12% respectively). Statistically significant improvements in bowel movement frequency and stool consistency were observed in the 4 mg/day group relative to placebo. Renzapride was well tolerated at all doses.
CONCLUSIONS: This study confirms the gastrointestinal prokinetic effects of renzparide. The data also suggested a potentially beneficial effect on abdominal pain/discomfort in women with constipation-predominant irritable bowel syndrome.
PMID 18284648 Aliment Pharmacol Ther. 2008 May;27(9):830-7. doi: 10.1111/j.1365-2036.2008.03649.x. Epub 2008 Feb 14.
|
