Kienzle-Horn S, Vix J-M, Schuijt C, Peil H, Jordan C C, Kamm M A
Scratch Pharmaberatung, Butzbach, Germany.
Aliment Pharmacol Ther. 2006 May 15;23(10):1479-88. doi: 10.1111/j.1365-2036.2006.02903.x.
Although laxatives are a first-line treatment for constipation, there are few randomized placebo-controlled trials assessing their efficacy.
To determine the effect and safety of oral bisacodyl on stool frequency and consistency in patients with idiopathic constipation.
55 patients (age 19-89 years) with idiopathic constipation were recruited from eight primary care practices and randomized to receive bisacodyl, 10 mg once daily, or placebo, on three successive days following a 3-day run-in period. Patients recorded stool frequency and consistency and adverse events. RESULTS; In each treatment group, 27 patients were evaluable for efficacy. The mean number of stools per day was significantly greater in the bisacodyl-treated group (1.8/day) compared with placebo (0.95/day) over the treatment phase (P=0.0061). Mean stool consistency score improved from 'hard' (run-in) to between 'soft' and 'well-formed' during bisacodyl treatment, remaining between 'moderately hard' and 'hard' for placebo treatment (P<0.0001). The investigator's global efficacy score was superior for the bisacodyl group compared with placebo. Both treatments were well tolerated. Serum electrolyte levels and incidence of adverse events were comparable between treatment groups.
Bisacodyl is effective and safe in improving stool frequency and consistency in acute treatment of idiopathic constipation.
尽管泻药是便秘的一线治疗方法，但评估其疗效的随机安慰剂对照试验很少。
确定口服比沙可啶对特发性便秘患者排便频率和大便稠度的影响及安全性。
从八个初级保健机构招募了55例年龄在19至89岁之间的特发性便秘患者，在经过3天的导入期后，随机分为连续三天接受10毫克每日一次的比沙可啶或安慰剂治疗。患者记录排便频率、大便稠度及不良事件。结果：在每个治疗组中，有27例患者可评估疗效。在治疗阶段，比沙可啶治疗组的日均排便次数（1.8次/天）显著高于安慰剂组（0.95次/天）（P = 0.0061）。比沙可啶治疗期间，大便稠度平均评分从“硬”（导入期）改善至“软”和“成形良好”之间，而安慰剂治疗期间则保持在“中度硬”和“硬”之间（P < 0.0001）。与安慰剂相比，比沙可啶组的研究者整体疗效评分更高。两种治疗耐受性均良好。治疗组之间血清电解质水平和不良事件发生率相当。
比沙可啶在特发性便秘的急性治疗中有效且安全，可改善排便频率和大便稠度。
