Johanson J F
University of Illinois College of Medicine, Rockford, IL, USA.
Aliment Pharmacol Ther. 2004 Nov;20 Suppl 7:20-4. doi: 10.1111/j.1365-2036.2004.02187.x.
Constipation is one of the most common gastrointestinal conditions with limited effective treatment options. Tegaserod, a 5-HT4 receptor agonist has demonstrated efficacy in relieving constipation-related symptoms in patients suffering from irritable bowel syndrome with constipation. This paper reviews two recent reports that have evaluated the efficacy and safety of tegaserod in patients with chronic constipation. Two double-blind, randomized, placebo-controlled trials have been reported; one in Europe and Asia (E2301) the other in North and South America (E2302). After a 2-week baseline period, patients were randomized to treatment with tegaserod 2 mg b.d., tegaserod 6 mg b.d. or placebo for 12 weeks. Two thousand, six hundred and twelve patients were randomized, the majority were white females. In both studies, responder rates during weeks 1-4 were significantly greater in the tegaserod groups compared with placebo. A similar trend was seen over weeks 1-12. Statistically significant improvements over placebo were seen across the majority of secondary efficacy variables. Tegaserod was safe with no consistent differences in the frequency of adverse events among the various groups. In conclusion, treatment of chronic constipation with tegaserod was associated with significant improvement in bowel frequency as well as other constipation symptoms. Tegaserod was also well tolerated in this patient population.
便秘是最常见的胃肠道疾病之一,有效的治疗选择有限。替加色罗是一种5-HT4受体激动剂,已证明可有效缓解患有便秘型肠易激综合征患者的便秘相关症状。本文综述了两篇最近评估替加色罗对慢性便秘患者疗效和安全性的报告。已报告两项双盲、随机、安慰剂对照试验;一项在欧洲和亚洲进行(E2301),另一项在北美洲和南美洲进行(E2302)。经过2周的基线期后,患者被随机分为接受替加色罗2mg每日两次、替加色罗6mg每日两次或安慰剂治疗12周。2612名患者被随机分组,大多数为白人女性。在两项研究中,替加色罗组在第1 - 4周的缓解率显著高于安慰剂组。在第1 - 12周也观察到类似趋势。在大多数次要疗效变量方面,与安慰剂相比有统计学显著改善。替加色罗安全,各治疗组不良事件发生率无一致差异。总之,用替加色罗治疗慢性便秘与排便频率以及其他便秘症状的显著改善相关。替加色罗在该患者群体中耐受性也良好。