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目的:验证斯巴敏治疗肠易激综合征(IBS)的有效性和安全性。方法:132例符合罗马Ⅱ诊断标准的18岁以上的IBS患者参加了国内7个中心进行的开放试验。患者经过1周的导入期后,开始服用斯巴敏一日3次,每次40mg,饭前服用。治疗期共12周。患者每日记日记,包括症状、有无不良反应及服药情况。每1个月来院随访1次,随访后2周增加1次电话随访,督促患者按时服药和记周记卡,包括服药后的总体感觉,有无其他不适,是否服用过其他药物。观察指标:①
Objective: To verify the efficacy and safety of sparmin in the treatment of irritable bowel syndrome (IBS). Methods: 132 IBS patients over 18 years old who meet the diagnostic criteria of Rome Ⅱ participated in the open trials conducted in 7 centers in China. Patients after 1 week of induction period, began taking sibanephine three times a day, each 40mg, taken before meals. The treatment period of 12 weeks. Patients diary daily diary, including symptoms, with or without adverse reactions and medication. The patients were followed up once every 1 month and followed up for 1 week by 2 weeks after follow-up. Patients were urged to take the medicine on time and remember the weekly card, including the general feeling after taking the medicine, whether there was any other discomfort and whether other drugs were taken. Observation index: ①