Van Outryve M, De Nutte N, Van Eeghem P, Gooris J P
Dept. of Gastroenterology, University Hospital of Antwerp, Edegem, Belgium.
Scand J Gastroenterol Suppl. 1993;195:47-52; discussion 52-3. doi: 10.3109/00365529309098328.
A double-blind, placebo-controlled trial was performed to determine the therapeutic efficacy of cisapride in patients with refractory functional dyspepsia. A total of 147 patients with functional dyspepsia characterized by prominent epigastric pain or discomfort were randomized to 2 weeks' treatment with metoclopramide or domperidone (both 30 mg/day); of these, 53 patients unresponsive to dopamine antagonist treatment were randomized to cisapride 30 mg/day or placebo for an additional 2 weeks. Metoclopramide and domperidone produced comparable alleviation of epigastric symptoms; global efficacy was good or excellent in 62% and 57% of patients, respectively. In refractory patients, cisapride tended to display greater efficacy than placebo against epigastric pain, particularly at night. Global assessments of efficacy significantly favored cisapride over placebo, with good or excellent ratings in 65% and 32% of patients, respectively. Cisapride was well tolerated. Thus, cisapride appears to be an effective agent in functional dyspepsia unresponsive to other gastrokinetic agents.
进行了一项双盲、安慰剂对照试验，以确定西沙必利对难治性功能性消化不良患者的治疗效果。共有147例以明显上腹部疼痛或不适为特征的功能性消化不良患者被随机分为接受甲氧氯普胺或多潘立酮治疗2周（均为30毫克/天）；其中，53例对多巴胺拮抗剂治疗无反应的患者被随机分为接受西沙必利30毫克/天或安慰剂治疗另外2周。甲氧氯普胺和多潘立酮对上腹部症状的缓解效果相当；总体疗效分别在62%和57%的患者中为良好或优秀。在难治性患者中，西沙必利在缓解上腹部疼痛方面往往比安慰剂显示出更大的疗效，尤其是在夜间。疗效的总体评估明显有利于西沙必利而非安慰剂，分别有65%和32%的患者评定为良好或优秀。西沙必利耐受性良好。因此，西沙必利似乎是一种对其他促胃肠动力药物无反应的功能性消化不良的有效药物。
