奥替溴铵治疗肠易激综合征有效性和安全性的研究

Efficacy and Safety of Otilonium Bromide for Irritable Bowel Syndrome

背景:肠易激综合征(IBS)是一种常见的肠道功能性疾病。奥替溴铵具有胃肠道解痉作用,国外已广泛用于IBS患者的治疗。目的:评估奥替溴铵治疗IBS患者的有效性和安全性。方法:采用多中心、开放性临床试验,132例符合RomeⅡ标准的IBS患者服用奥替溴铵40 mg,3次/d共12周(餐前服用),治疗前后分别对患者的腹痛、排便异常和生活质量进行评估。结果:IBS患者经奥替溴铵治疗后,腹痛视觉模拟量表(VAS)评分显著降低(P<0.05),主诉疼痛程度和腹痛频率亦显著降低(P<0.01)。同时患者的排便频率和大便性状显著改善,黏液便显著减少,生活质量显著改善。用奥替溴铵治疗的不良反应发生率仅为7.6％。结论:奥替溴铵是一种有效、安全的缓解IBS症状的药物。

Background: Irritable bowel syndrome (IBS) is a common intestinal functional disorder. Otilo-nium bromide has antispasmodic effect on gastrointestinal muscle, and is widely used for IBS patients in many countries. Aims: To evaluate the efficacy and safety of otilonium bromide in the treatment of IBS patients. Methods: A multicenter and open clinical trial were designed. One hundred and thirty-two patients with IBS (Rome II criteria) were enrolled in this study. Otilonium bromide was given 40 mg tid, a.c. for 12 weeks. Abdominal pain, defecation abnormality, and quality of life were evaluated before and after the treatment. Results: The score of abdominal pain visual analogue scale (VAS) in IBS patients declined dramatically after otilonium bromide medication (P<0.05), the complaint and the frequency of abdominal pain also decreased significantly (P<0.01). Simultaneously, the frequency of defecation and the consistency of stool ameliorated with the mucus reduced, and the quality of life improved markedly. The incidence of adverse effects of otilonium bromide was only 7.6%. Conclusions: Otilonium bromide is an effective and safe agent for alleviation of symptoms in IBS.