口服莫沙必利治疗功能性消化不良的随机对照试验

目的　观察新型促胃肠动力药莫沙必利 (胃 5 HT4受体促进剂 )对功能性消化不良 (FD)的随机对照试验。方法　FD患者 42例 ,随机分为试验组 (2 1例 ,服枸橼酸莫沙必利片 )和对照组 (2 1例 ,服吗叮啉片 )。采用GCP标准 ,双盲法观察 ,在实验开始前、服药第 1 4、2 8天记录症状变化及副作用发生情况。随机抽取部分患者于实验开始前和结束时做99MTc胃排空试验。结果　莫沙必利对FD症状的疗效与吗叮啉组相当 (P >0 .0 5 )。99MTc胃排空测定发现莫沙必利组治疗后的半排时间 (45 .0 5± 1 2 .2 1 )min缩短 ,1 2 0min残留率 (2 9.73%± 8.5 1 % )减少 (P <0 .0 5 ) ,两组病例未发现毒副反应。结论　莫沙必利对于FD疗效良好 ,对胃排空延迟有良好疗效 ,安全度高。

RCT on the therapautical effect of mospride citrate in functional dyspe psia

Objective To observe the curative effect and side effect of the gastrokinetic agent mosapride citrate by RCT. Methods 42 cases of functional dyspepsia (FD) were divided into two groups randomly, the group of mosapride(21 cases):orally administrated mosapride, 5mg, t.i.d for 4 weeks, and the control (21 cases):orally administrated domperidone, 5mg, t.i.d for 4 weeks. Symptoms and side effects were recorded before and at d 14, d 28 after administration of the medicines according to GCP and double blind priciple. Gastric empting test was also carried out in randomly selected patients. Results Mosapride and domperidone were significantly effective on alleviating symptoms of the patient with FD. In mosapride treated group the half emptying time was shortened and the 120 min remain rate was reduced. No side effect was found. Conclusion These results suggest that mosapride 5 mg t.i.d. is effective and safe on alleviating symptoms of patients with FD and improving the gastric empting time.