莫沙必利治疗功能性消化不良的随机双盲对照研究

A randomized controlled Multi-center clinical trial on mosapride in the treatment of functional dyspepsia

目的 评价枸橼酸莫沙必利治疗功能性消化不良的疗效及安全性。方法 采用随机对照双盲的临床试验设计方案。对象为功能性消化不良患者。试验组莫沙必利5mg,对照组多潘立酮10mg,均为每日3次,疗程4周。评价症状改善、胃排空和不良反应。结果 231例入选病例中222例(96.1％)完成治疗和随访。试验组治疗2周后对早饱、上腹胀症状的总有效率分别为84.5％和90.1％,与对照组(分别为75.9％、82.2％)相似,但改善嗳气和烧心感明显优于对照组(P<0.05)。治疗4周时试验组改善上腹胀和嗳气症状明显优于对照组(P<0.05)。治疗后症状积分总和下降幅度试验组明显大于对照组(P<0.05)。对治疗前存在胃排空障碍的患者,治疗4周后,无论胃排空恢复正常的患者比例(46.2％vs、25.9％,P=0.020)或者残留率下降幅度(46.2％vs. 24.0％,P=0.003)试验组均明显大于对照组。两组总的不良反应发生率为11.7％(试验组9.6％,对照组14.0％;P=0.30),均较轻。结论 枸橼酸莫沙必利治疗可明显改善功能性消化不良患者的症状和胃排空,不良反应少,值得临床推广应用。

Objective To evaluate the effectiveness and safety of mosapride on treatment of functional dyspepsia. Methods Randomized controlled clinical trial was conducted and patients suffered from functional dyspepsia were included. 5 mg mosapride was given three times daily for 4 weeks in the treatment group. 10 mg domperidone was given three times daily for 4 weeks as control. Changes on symptom score, gastric empty or new occurring events were included as outcomes. Results 231 patients suffered from functional dyspepsia were selected by inclusion and exclusion criteria from August 15 to Oct 22, 1999. Of these, 108 (46. 8%) were males, versus 123 (53.2%) females and 118 (51.2%) in the treatment group and 113 (48. 9%) as controls. 222 (96. 1%) patients were followed up. Results showed that the total efficacy rates in early satiety and abdominal distension were 84. 5% and 90. 1% in mosapride after the 2 weeks of treatment. Mosapride seemed to be more effective in improving symptoms of belching and heartburn than that in controls (P< 0. 05). In 4 weeks, the total efficacy in improving symptoms of abdominal distention and belching showed more effective in mosapride than that in controls (P< 0. 05). Decrease of symptoms score was more in mosapride than that in controls (P< 0. 05). Mosapride was less effective in controls in improving the gastric empty in terms of proportion (46. 2% vs. 25. 9%, P = 0. 020) and range (46. 2% vs. 24. 0%, P = 0. 003). Side effects would include diarrhea, constipation, headache, dizziness, insomnia, skin scare and the like. There was no significant difference between the two groups (9. 6% in mosapride vs. 14. 0% in controls). Conclusion Mosapride was safe and effective in improving the symptoms and gastric empty of functional dyspepsia.