Camilleri M, Malagelada J R, Abell T L, Brown M L, Hench V, Zinsmeister A R
Department of Nuclear Medicine, Mayo Clinic, Rochester, Minnesota.
Gastroenterology. 1989 Mar;96(3):704-12.
We have investigated the effect of oral cisapride (10 mg t.i.d.) in a double-blind, placebo-controlled trial in 26 patients with upper gut dysmotility: 11 with gastroparesis (8 diabetic, 3 idiopathic) and 15 with chronic idiopathic intestinal pseudoobstruction. Patients were evaluated at entry and at the end of the 6-wk study by upper gastrointestinal manometry, scintigraphic evaluation of gastric emptying of solids and liquids, measurement of body weight, and scoring of the following symptoms: abdominal pain, nausea, vomiting, early satiety, bloating, and distention. Cisapride and placebo groups were strictly comparable for all parameters assessed. Cisapride resulted in a significant increase in the gastric emptying of solids (p less than 0.05) compared with placebo; cisapride also tended to increase the postcibal antral motility and normalize the abnormal manometric features in the patients with intestinal dysmotility, particularly the characteristics of fasting interdigestive motor complexes and the fed motor pattern. Both cisapride and placebo groups showed an improvement in total symptom scores and there was no significant difference in overall symptom response between the two groups. However, the change in abdominal pain was greater with cisapride (p = 0.07). Cisapride facilitates gastric emptying in patients with upper gut dysmotility. The overall symptomatic benefit during a 6-wk trial of cisapride, 10 mg t.i.d., was not greater than that of placebo, and dose-response as well as longer term trials are necessary to determine the clinical efficacy of this medication.
我们在一项双盲、安慰剂对照试验中，对26例上消化道动力障碍患者研究了口服西沙必利（10毫克，每日三次）的效果：其中11例患有胃轻瘫（8例糖尿病性，3例特发性），15例患有慢性特发性假性肠梗阻。在入组时和为期6周的研究结束时，通过上消化道测压、固体和液体胃排空的闪烁扫描评估、体重测量以及对以下症状进行评分来评估患者：腹痛、恶心、呕吐、早饱、腹胀和腹部膨隆。西沙必利组和安慰剂组在所有评估参数方面严格可比。与安慰剂相比，西沙必利使固体胃排空显著增加（p<0.05）；西沙必利还倾向于增加餐后胃窦动力，并使肠道动力障碍患者的异常测压特征正常化，特别是空腹消化间期运动复合波的特征和进食时的运动模式。西沙必利组和安慰剂组的总症状评分均有改善，两组之间的总体症状反应无显著差异。然而，西沙必利使腹痛的改善更大（p = 0.07）。西沙必利可促进上消化道动力障碍患者的胃排空。在一项为期6周试验中，每日三次服用10毫克西沙必利的总体症状获益并不大于安慰剂，需要进行剂量反应以及长期试验来确定该药物的临床疗效。
