Chey William D, Paré Pierre, Viegas Andrea, Ligozio Gregory, Shetzline Michael A
University of Michigan Health System, Division of Internal Medicine, Ann Arbor, Michigan, USA.
Am J Gastroenterol. 2008 May;103(5):1217-25. doi: 10.1111/j.1572-0241.2008.01808.x.
Though the greatest proportion of irritable bowel syndrome (IBS) patients report a mixed bowel pattern (IBS-Mixed), no available therapies have been rigorously evaluated in this subgroup. This study aimed to evaluate the efficacy and safety of the 5-HT(4) agonist tegaserod in women with IBS-Mixed and IBS with constipation (IBS-C).
This prospective, double-blind, randomized, placebo-controlled, multicenter study was conducted in 100 centers in North America, South America, and Europe. Women with IBS-Mixed or IBS-C received tegaserod 6 mg or placebo twice daily. The primary efficacy variable was the patient's assessment of satisfactory relief over the 4-wk treatment period. The proportion of patients reporting satisfactory relief for >/=3 of 4 treatment weeks (75% rule) and individual IBS symptoms were assessed.
In total, 661 women were randomized (IBS-Mixed 324, IBS-C 337). Baseline symptom assessments identified clear differences between the two cohorts. Tegaserod provided significant improvement in satisfactory relief of IBS symptoms over 4 wk (OR 1.75, 95% CI 1.35-2.25, P < 0.001) in both IBS-Mixed and IBS-C patients. Using the 75% rule, 52.3% of tegaserod-receiving IBS-M patients and 43.3% of IBS-C patients were responders (vs 36.3, OR 1.88, 95% CI 1.16-3.04, P < 0.010; and 28.9, OR 1.90, 95% CI 1.19-3.05, P < 0.008 for placebo, respectively). The most frequent adverse events leading to study discontinuation in tegaserod-treated patients were diarrhea (1.5%) and abdominal pain (0.9%). Overall 7% of IBS-C patients reported diarrhea compared to 12% of IBS-Mixed (placebo 2.4%, 1.8%, respectively).
Tegaserod is effective in treating overall IBS symptoms in patients with IBS-Mixed and IBS-C.
尽管最大比例的肠易激综合征（IBS）患者报告有混合型排便模式（IBS-混合型），但尚无可用疗法在该亚组中得到严格评估。本研究旨在评估5-羟色胺（4）激动剂替加色罗对IBS-混合型和便秘型IBS（IBS-C）女性患者的疗效和安全性。
这项前瞻性、双盲、随机、安慰剂对照、多中心研究在北美、南美和欧洲的100个中心进行。IBS-混合型或IBS-C女性患者每日两次接受6毫克替加色罗或安慰剂治疗。主要疗效变量是患者对4周治疗期内症状得到满意缓解的评估。评估了报告在4个治疗周中≥3周症状得到满意缓解的患者比例（75%规则）以及个体IBS症状。
总共661名女性被随机分组（IBS-混合型324名，IBS-C 337名）。基线症状评估发现两个队列之间存在明显差异。替加色罗在4周内使IBS-混合型和IBS-C患者的IBS症状满意缓解率有显著提高（比值比1.75，95%置信区间1.35 - 2.25，P < 0.001）。采用75%规则，接受替加色罗治疗的IBS-M患者中有52.3%、IBS-C患者中有43.3%为缓解者（安慰剂组分别为36.3%，比值比1.88，95%置信区间1.16 - 3.04，P < 0.010；以及28.9%，比值比1.90，95%置信区间1.19 - 3.05，P < 0.008）。替加色罗治疗患者中导致研究中止的最常见不良事件是腹泻（1.5%）和腹痛（0.9%）。总体而言，IBS-C患者中有7%报告有腹泻，而IBS-混合型患者中有12%（安慰剂组分别为2.4%和1.8%）。
替加色罗对IBS-混合型和IBS-C患者的总体IBS症状有效。
