Holloway R H, Downton J, Mitchell B, Dent J
Department of Medicine, Flinders Medical Centre, Bedford Park, South Australia.
Gut. 1989 Sep;30(9):1187-93. doi: 10.1136/gut.30.9.1187.
We studied the effect of cisapride on oesophageal motor function and postprandial gastro-oesophageal reflux in a randomised, double blind, placebo controlled crossover study. In 16 patients with symptomatic gastro-oesophageal reflux, cisapride 10 mg orally and placebo were studied on separate days according to identical protocols. Cisapride and placebo were given 30 minutes before a standard meal. Each study day was preceded by corresponding three day oral loading of cisapride (10 mg tds) or placebo. Lower oesophageal sphincter pressure, oesophageal body motility and oesophageal pH were monitored for 30 minutes before and three hours after the meal. Plasma cisapride concentrations were measured before and after dosing on both study days. With cisapride treatment, the plasma cisapride levels ranged from 48.1 (5.0) to 75.9 (6.9) ng/ml. Plasma levels were undetectable during placebo treatment. Cisapride enhanced acid clearance but had no significant effect on the duration of acid exposure, the rate of reflux episodes, the pattern of lower oesophageal sphincter pressure associated with the reflux episodes, basal lower oesophageal sphincter pressure or oesophageal peristalsis. These findings do not suggest a major role for cisapride, at the dosage tested, for the control of troublesome postprandial gastro-oesophageal reflux.
我们在一项随机、双盲、安慰剂对照的交叉研究中,研究了西沙必利对食管运动功能和餐后胃食管反流的影响。在16例有症状的胃食管反流患者中,按照相同方案在不同日期分别研究了口服10毫克西沙必利和安慰剂的情况。西沙必利和安慰剂在标准餐前进食30分钟服用。每个研究日之前,先进行为期三天的西沙必利(10毫克,每日三次)或安慰剂口服负荷。在进餐前30分钟和进餐后三小时监测食管下括约肌压力、食管体部运动和食管pH值。在两个研究日给药前后均测量血浆西沙必利浓度。西沙必利治疗期间,血浆西沙必利水平范围为48.1(5.0)至75.9(6.9)纳克/毫升。安慰剂治疗期间血浆水平检测不到。西沙必利可增强酸清除,但对酸暴露持续时间、反流发作频率、与反流发作相关的食管下括约肌压力模式、基础食管下括约肌压力或食管蠕动无显著影响。这些发现表明,在所测试的剂量下,西沙必利在控制麻烦的餐后胃食管反流方面没有主要作用。