Vakil Nimish, Laine Loren, Talley Nicholas J, Zakko Salam F, Tack Jan, Chey William D, Kralstein Jeffrey, Earnest David L, Ligozio Gregory, Cohard-Radice Marielle
University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin and Marquette University College of Health Sciences, Milwaukee, Wisconsin 53233, USA.
Am J Gastroenterol. 2008 Aug;103(8):1906-19. doi: 10.1111/j.1572-0241.2008.01953.x. Epub 2008 Jul 4.
Therapies for dysmotility-like functional dyspepsia (FD) are limited. We studied tegaserod, a selective serotonin type 4 receptor agonist, in patients with FD.
Two identical multicenter, double-blind, randomized, placebo-controlled trials enrolled women >/=18 yr with recurring mid-upper abdominal discomfort characterized by postprandial fullness, early satiety, and/or bloating. Patients were randomized to tegaserod 6 mg b.i.d. or placebo. Two patient-reported primary variables were assessed: percentage of days with satisfactory symptom relief, and symptom severity using the composite average daily severity score (CADSS).
In total, 2,667 women were randomized with no differences between trials in terms of recruitment method, Helicobacter pylori status, heartburn, or medication use. Mean percentage of days with satisfactory symptom relief for tegaserod versus placebo in Trial 1: 32.2%versus 26.6% (95% CI of treatment difference 2.82, 9.27; P < 0.01), Trial 2: 31.9%versus 29.4% (95% CI of treatment difference -0.21, 6.53; P= 0.066). Mean CADSS in Trial 1: 3.14 versus 3.35 (95% CI of treatment difference -0.29, -0.10; P < 0.0001), Trial 2: 3.15 versus 3.23 (95% CI of treatment difference -0.18, 0.01; P= 0.094). Meta-analysis showed significant benefit for both end points: increase in days with satisfactory relief 4.6% (95% CI 2.29, 6.96); decrease in CADSS 0.14 (95% CI 0.21, 0.07). Treatment effect was greater in patients with severe baseline symptoms. Diarrhea requiring study discontinuation was more common with tegaserod than placebo (4.1%vs 0.3%).
Some improvement in dysmotility-like FD was observed with tegaserod treatment. The clinical implication of this improvement is uncertain.
动力障碍样功能性消化不良（FD）的治疗方法有限。我们对替加色罗（一种选择性5-羟色胺4型受体激动剂）在FD患者中的疗效进行了研究。
两项相同的多中心、双盲、随机、安慰剂对照试验纳入了年龄≥18岁、反复出现中上腹不适（表现为餐后饱胀、早饱及/或腹胀）的女性患者。患者被随机分为替加色罗6mg每日两次组或安慰剂组。评估了两个患者报告的主要变量：症状缓解满意天数的百分比，以及使用综合平均每日严重程度评分（CADSS）评估的症状严重程度。
共有2667名女性被随机分组，两项试验在招募方法、幽门螺杆菌感染状况、烧心或用药情况方面无差异。试验1中，替加色罗组与安慰剂组症状缓解满意天数的平均百分比分别为32.2%和26.6%（治疗差异的95%CI为2.82, 9.27；P<0.01），试验2中分别为31.9%和29.4%（治疗差异的95%CI为-0.21, 6.53；P = 0.066）。试验1中CADSS的平均值分别为3.14和3.35（治疗差异的95%CI为-0.29, -0.10；P<0.0001），试验2中分别为3.15和3.23（治疗差异的95%CI为-0.18, 0.01；P = 0.094）。荟萃分析显示，两个终点均有显著益处：症状缓解满意天数增加4.6%（95%CI为2.29, 6.96）；CADSS降低0.14（95%CI为0.21, 0.07）。在基线症状严重的患者中治疗效果更佳。因腹泻而需要停药的情况在替加色罗组比安慰剂组更常见（4.1%对0.3%）。
替加色罗治疗动力障碍样FD有一定改善。这种改善的临床意义尚不确定。
