医学
肠易激综合征
安慰剂
便秘
内科学
腹痛
临床终点
胃肠病学
人口
随机对照试验
替代医学
环境卫生
病理
作者
Michael Camilleri,Northcutt Allison Ruth,S. Kong,George E. Dukes,David J. McSorley,Allen W. Mangel
出处
期刊:The Lancet
[Elsevier]
日期:2000-03-25
卷期号:355 (9209): 1035-1040
被引量:528
标识
DOI:10.1016/s0140-6736(00)02033-x
摘要
Irritable bowel syndrome (IBS) is a common gastrointestinal disorder with symptoms of abdominal pain, discomfort, and altered bowel function. Antagonists of the type 3 serotonin receptor (5-HT3) have shown promising results in the relief of IBS-associated symptoms. We aimed to confirm these findings by doing a randomised, placebo-controlled trial.We studied 647 female IBS patients with diarrhoea-predominant or alternating bowel patterns (diarrhoea and constipation). 324 patients were assigned 1 mg alosetron and 323 placebo orally twice daily for 12 weeks, followed by a 4-week post-treatment period. Adequate relief of abdominal pain and discomfort was the primary endpoint; secondary endpoints included improvements in urgency, stool frequency, and stool consistency. Analysis was by intention to treat.79 (24%) of patients in the alosetron group and 53 (16%) in the placebo group dropped out. The difference in the drop-out rate between groups was mainly due to a greater occurrence of constipation in the alosetron group. A greater proportion of alosetron-treated patients than placebo-treated patients (133 [41%] vs 94 [29%], respectively) reported adequate relief for all 3 months of treatment (difference 12% [4.7-19.2]). Alosetron also significantly decreased urgency and stool frequency, and increased stool firmness. Constipation occurred in 30% and 3% of patients in the alosetron and placebo groups, respectively.Alosetron was well tolerated and clinically effective in alleviating pain and bowel-related symptoms in this population of women with IBS.
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