Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
J Neurogastroenterol Motil. 2010 Jan;16(1):61-70. doi: 10.5056/jnm.2010.16.1.61. Epub 2010 Jan 31.
Tegaserod has been used for treatment of irritable bowel syndrome (IBS) but there is no data regarding its effect on Korean patients. The aim of this study was to evaluate the effect of tegaserod on symptoms and quality of life (QOL) in Korean female IBS patients with constipation and to evaluate the usefulness of the IBS-QOL in clinical study.
A prospective, open labeled, multicenter study was performed. Female patients fulfilling Rome II criteria for IBS received 6 mg of tegaserod twice a day for 4 weeks. The efficacy on IBS symptoms and QOL was assessed using 7-point scaled symptom questionnaire and IBS-QOL questionnaire, respectively.
A total of 81 female patients (range 18-73 years of age) were enrolled in this study. Tegaserod therapy significantly reduced the overall symptom scores after 4 weeks (p <0.01). The improved symptoms included abdominal discomfort or pain, hard or lumpy stool, straining during a bowel movement, feeling of incomplete bowel movement, and abdominal fullness or bloating. The IBS-QOL of responders to tegaserod treatment was also significantly improved after 4 weeks (p <0.01). Furthermore, improvement of symptom scores significantly correlated with improvement of the IBS-QOL scores (r = -0.60, p <0.001).
Tegaserod 6 mg given twice daily improved the QOL as well as the bowel symptoms in Korean female IBS patients with constipation. The IBS-QOL can be used as a reliable end-point in clinical study.
替加色罗曾被用于治疗肠易激综合征(IBS),但目前尚无其对韩国患者疗效的数据。本研究旨在评估替加色罗对韩国女性便秘型 IBS 患者症状和生活质量(QOL)的影响,并评估 IBS-QOL 在临床研究中的有用性。
一项前瞻性、开放标签、多中心研究。符合 Rome II 标准的女性 IBS 患者接受替加色罗 6mg,每日两次,治疗 4 周。采用 7 分制症状问卷和 IBS-QOL 问卷分别评估 IBS 症状和 QOL 的疗效。
本研究共纳入 81 名女性患者(年龄 18-73 岁)。替加色罗治疗 4 周后,整体症状评分显著降低(p<0.01)。改善的症状包括腹部不适或疼痛、硬便或块状便、排便时用力、排便不尽感和腹胀或饱胀。对替加色罗治疗有反应的患者的 IBS-QOL 也在 4 周后显著改善(p<0.01)。此外,症状评分的改善与 IBS-QOL 评分的改善显著相关(r=-0.60,p<0.001)。
替加色罗 6mg,每日两次,可改善韩国女性便秘型 IBS 患者的 QOL 和肠道症状。IBS-QOL 可作为临床研究中可靠的终点指标。