Richards R D, Valenzuela G A, Davenport K G, Fisher K L, McCallum R W
Division of Gastroenterology, University of Virginia Medical Center, Charlottesville 22908.
Dig Dis Sci. 1993 May;38(5):811-6. doi: 10.1007/BF01295905.
Cisapride, a relatively new gastrointestinal prokinetic agent, has been reported to increase gastric emptying and improve symptoms of gastroparesis. We investigated these effects of cisapride in patients with severe idiopathic and diabetic gastroparesis during an eight-week trial. The study design was a two-week single-blind placebo run in period to exclude placebo responders, followed by a six-week randomized, double-blind, placebo-controlled treatment phase. Delayed gastric emptying of solids on radionuclide scan and a minimum symptom intensity score were inclusion criteria. Forty-three patients were entered: four placebo responders and one other patient were excluded, leaving 19 patients randomized to cisapride (20 mg per os three times a day before meals), and 19 patients to placebo. Seven individual symptoms of gastroparesis were scored in a daily diary and reviewed at two-week visits. Sixteen patients in the cisapride group were able to complete the trial compared to 12 on placebo. The gastric emptying study was repeated at the end of treatment or at the time of withdrawal for those who dropped out. Cisapride significantly increased solid gastric emptying relative to baseline (P = 0.005) whereas placebo did not (P > 0.10). Cisapride did not significantly improve any symptom of gastroparesis relative to baseline or to placebo. We conclude that in a population of severe, refractory gastroparetic patients cisapride significantly accelerates gastric emptying of a solid meal without significantly reducing symptoms during a short-term treatment trial compared to placebo. Further trials of cisapride in less advanced and "end-stage" gastroparetics than studied here or combining cisapride with other prokinetic agents or antiemetics, are warranted.
西沙必利是一种相对较新的胃肠促动力剂，据报道它能加快胃排空并改善胃轻瘫症状。我们在一项为期八周的试验中研究了西沙必利对重度特发性和糖尿病性胃轻瘫患者的这些作用。研究设计为为期两周的单盲安慰剂导入期，以排除安慰剂反应者，随后是为期六周的随机、双盲、安慰剂对照治疗阶段。放射性核素扫描显示固体胃排空延迟以及最低症状强度评分是纳入标准。43名患者入组：4名安慰剂反应者和另1名患者被排除，剩下19名患者随机分为西沙必利组（口服20毫克，每日三次，饭前服用）和19名患者为安慰剂组。在每日日记中对胃轻瘫的7种个体症状进行评分，并在两周一次的访视时进行复查。西沙必利组有16名患者能够完成试验，而安慰剂组为12名。对于退出试验的患者，在治疗结束时或退出时重复进行胃排空研究。与基线相比，西沙必利显著增加了固体胃排空（P = 0.005），而安慰剂则没有（P > 0.10）。与基线或安慰剂相比，西沙必利并未显著改善胃轻瘫的任何症状。我们得出结论，在重度难治性胃轻瘫患者群体中，与安慰剂相比，西沙必利在短期治疗试验中能显著加速固体餐的胃排空，但未显著减轻症状。有必要对西沙必利在比本研究中病情较轻和“终末期”胃轻瘫患者中进行进一步试验，或者将西沙必利与其他促动力剂或止吐药联合使用。
