CAJ | 학술논문

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4 2例，随机分为试验组（21例，服枸橼酸莫沙必利片）和对照组（21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14、28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＞0.05）。99MTc胃排空测定发现莫沙必利组治疗后的半排时间（45.05±12.21） min缩短，120 min残留率（29.73 ％±8.51％）减少（P＜0．05），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。
목적관찰신형촉위장동력약막사필리（위5-HT4수체촉진제）대공능성소화불량（FD）적수궤대조시험。방법 FD환자4 2례，수궤분위시험조（21례，복구연산막사필리편）화대조조（21례，복마정람편）。채용GCP표준，쌍맹법관찰，재실험개시전、복약제14、28천기록증상변화급부작용발생정황。수궤추취부분환자우실험개시전화결속시주99MTc위배공시험。결과막사필리대FD증상적료효여마정람조상당（P＞0.05）。99MTc위배공측정발현막사필리조치료후적반배시간（45.05±12.21） min축단，120 min잔류솔（29.73 ％±8.51％）감소（P＜0．05），량조병례미발현독부반응。결론막사필리대우FD료효량호，대위배공연지유량호료효，안전도고。
Objective　To observe the curative effect and sid e effect of the gastrokinetic agent mosapride citrate by RCT. Methods　 42 cases of functional dyspepsia (FD) were divided into two groups rando mly, 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 pri ciple. 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 sid e effect was found. Conclusion　These results suggest that mosa pride 5 mg t.i.d. is effective and safe on alleviating symptoms of patients with FD and improving the ga stric empting time.