Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial
Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial
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DOI：
10.1016/s0140-6736(00)02033-x
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发表时间：
2000-03-25
期刊：
影响因子：
168.9
通讯作者：
Mangel, AW
中科院分区：
文献类型：
--
作者：
Camilleri, M;Northcutt, AR;Mangel, AW
背景肠易激综合征（IBS）是一种常见的胃肠道疾病，症状为腹痛、不适和肠功能改变。3型5-羟色胺受体（5-HT 3）的拮抗剂在缓解IBS相关症状方面显示出有希望的结果。我们的目的是通过做一个随机的，安慰剂对照trial.Methods，我们研究了647例女性IBS患者的腹泻为主或交替的肠道模式（腹泻和便秘），以确认这些发现。324名患者被分配为1 mg阿洛司琼和323名安慰剂口服，每日两次，持续12周，随后是4周的治疗后阶段。腹痛和不适的充分缓解是主要终点;次要终点包括尿急、大便频率和大便粘稠度的改善。结果79例（24%）患者在阿洛司琼组和53例（16%）在安慰剂组退出。组间脱落率的差异主要是由于阿洛司琼组便秘的发生率更高。在所有3个月的治疗中，阿洛司琼治疗患者报告充分缓解的比例高于安慰剂治疗患者（分别为133例[41%] vs 94例[29%]）（差异12% [4.7-19.2]）。阿洛司琼还显著降低尿急和排便频率，并增加粪便硬度。阿洛司琼组和安慰剂组分别有30%和346例患者发生并发症，阿洛司琼耐受性良好，在缓解IBS女性患者疼痛和肠道相关症状方面临床有效。
Background 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.Methods 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.Findings 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 346 of patients in the alosetron and placebo groups, respectively.Interpretation Alosetron was well tolerated and clinically effective in alleviating pain and bowel-related symptoms in this population of women with IBS.