首页> 外文期刊>European journal of gastroenterology and hepatology >Tegaserod is safe, well tolerated and effective in the treatment of patients with non-diarrhoea irritable bowel syndrome.
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Tegaserod is safe, well tolerated and effective in the treatment of patients with non-diarrhoea irritable bowel syndrome.

机译:Tegaserod在治疗非腹泻性肠易激综合征的患者中是安全,耐受性良好且有效的。

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OBJECTIVE: To evaluate the safety/tolerability and efficacy of tegaserod, a 5-HT4 receptor partial agonist, in the treatment of patients with non-diarrhoea irritable bowel syndrome (non-D-IBS) in Switzerland. METHODS: This was an 8-week, open-label, prospective, multicentre study. Patients (>/=18 years old) met the Rome II diagnostic criteria for IBS, excluding those with diarrhoea for >/=14 days in the previous 3 months. Details of IBS symptoms experienced in the preceding week were recorded at visit 1 (day 1). Eligible patients received 6 mg tegaserod twice daily for 8 weeks. Adverse events (AEs) and serious AEs were recorded, along with detailed assessment of diarrhoeal episodes. Efficacy assessments included the overall number and percentage of responders after 8 weeks' treatment. RESULTS: A total of 850 patients (72% women; mean age, 51.4 years) were enrolled, and 843 received at least one dose of tegaserod. AEs were reported in 38% of patients, of which 13% were drug-related. Diarrhoea occurred early during treatment (13% in the first week, 7% thereafter), was mild to moderate in severity, was transient and was resolved with continued treatment. In total, 208 patients left the study early, primarily due to AEs. Diarrhoea accounted for 68 of these discontinuations. Nine serious AEs were reported but these were not related to tegaserod treatment. Sixty-six percent of patients responded to tegaserod on the Subject's Global Assessment of relief after 8 weeks. Benefits were also seen across individual IBS symptoms. CONCLUSION: Tegaserod (6 mg twice daily) appears to be safe, well-tolerated and effective in the treatment of non-D-IBS over 8 weeks.
机译:目的:评估瑞士5-HT4受体局部激动剂替加色罗治疗非腹泻型肠易激综合征(non-D-IBS)的安全性/耐受性和疗效。方法:这是一个为期8周的开放标签,前瞻性,多中心研究。患者(> / = 18岁)符合IBS的罗马II诊断标准,但前3个月腹泻时间> / = 14天的患者除外。在第1天(第1天)记录了前一周发生的IBS症状的详细信息。符合条件的患者每天两次接受6毫克替加色罗治疗,持续8周。记录不良事件(AE)和严重的AE,并详细评估腹泻发作。疗效评估包括治疗8周后应答者的总数和百分比。结果:总共招募了850例患者(72%为女性;平均年龄51.4岁),其中843例接受了至少一剂替加色罗治疗。据报道38%的患者发生AE,其中13%与药物相关。腹泻发生在治疗初期(第一周为13%,此后为7%),轻度至中度,短暂且经继续治疗后可缓解。总共有208位患者因不良事件而提前退出研究。腹泻占这些中断的68。据报道有九种严重不良事件,但与替加色罗治疗无关。 8周后,有66%的患者在受试者的总体缓解评估中对替加色罗有反应。在各个IBS症状中也看到了益处。结论:替加色罗(每天两次,每次6 mg)在8周内治疗非D-IBS似乎是安全,耐受性良好且有效的。

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