Müller-Lissner S A, Fumagalli I, Bardhan K D, Pace F, Pecher E, Nault B, Rüegg P
Park-Klinik Weissensee, Berlin, Germany.
Aliment Pharmacol Ther. 2001 Oct;15(10):1655-66. doi: 10.1046/j.1365-2036.2001.01094.x.
To investigate the efficacy and safety of tegaserod, a novel 5-HT(4) receptor partial agonist, in a randomized, double-blind, placebo-controlled, 12-week treatment, multicentre study.
Eight hundred and eighty-one patients with irritable bowel syndrome, characterized by abdominal pain, bloating and constipation, received tegaserod, 2 mg b.d. or 6 mg b.d., or placebo for 12 weeks.
Tegaserod, 2 mg b.d. and 6 mg b.d., showed a statistically significant relief of overall irritable bowel syndrome symptoms, measured by a weekly, self-administered questionnaire. At end-point, treatment differences from placebo were 12.7% and 11.8% for 2 mg b.d. and 6 mg b.d., respectively. The effect of tegaserod was noted as early as week 1, and was sustained over the 12-week treatment period. Individual irritable bowel syndrome symptoms assessed daily also showed a statistically significant improvement of abdominal discomfort/pain, number of bowel movements and stool consistency, and a favourable trend for reducing days with significant bloating. Adverse events were similar in all groups, with transient diarrhoea being the only adverse event seen more frequently with tegaserod than placebo.
Based upon the results of this study, tegaserod offers rapid and sustained relief of the abdominal pain and constipation associated with irritable bowel syndrome. Tegaserod is also well tolerated.
在一项随机、双盲、安慰剂对照、为期12周的多中心治疗研究中，调查新型5-羟色胺（5-HT）4受体部分激动剂替加色罗的疗效和安全性。
881例以腹痛、腹胀和便秘为特征的肠易激综合征患者接受替加色罗治疗，每日2次，每次2mg或每日2次，每次6mg，或接受安慰剂治疗12周。
通过每周的自我管理问卷测量，每日2次，每次2mg和每日2次，每次6mg的替加色罗在缓解肠易激综合征总体症状方面具有统计学意义。在研究终点，每日2次，每次2mg和每日2次，每次6mg的替加色罗与安慰剂相比，治疗差异分别为12.7%和11.8%。替加色罗的效果在第1周就已显现，并在12周的治疗期内持续存在。每日评估的个体肠易激综合征症状在腹部不适/疼痛、排便次数和大便稠度方面也显示出统计学意义上的显著改善，并且在减少严重腹胀天数方面有良好趋势。所有组的不良事件相似，短暂性腹泻是替加色罗组比安慰剂组更常出现的唯一不良事件。
基于本研究结果，替加色罗能快速并持续缓解与肠易激综合征相关的腹痛和便秘。替加色罗耐受性也良好。
