曲美布汀联合莫沙必利治疗功能性消化不良113例

Efficacy of Trimebutine Combined with Mosapride on Functional Dyspepsia

目的观察曲美布汀联合莫沙必利治疗功能性消化不良的疗效和安全性。方法将功能性消化不良患者347例,随机分为曲美布汀组(治疗A组)和莫沙必利组(治疗B组)各116例,曲美布汀联合莫沙必利组(联合组)115例。治疗A组给予马来酸曲美布汀片0.2 g,tid,饭后服;治疗B组给予枸橼酸莫沙必利片5 mg,tid,饭前服;联合组给予马来酸曲美布汀片联合枸橼酸莫沙必利片,其中马来酸曲美布汀片每次0.2 g,tid,饭后服,枸橼酸莫沙必利片每次5 mg,tid,饭前服。3组患者疗程均为4周。评价各组症状改善指标和不良反应。结果 347例入选患者中339例完成治疗和随访。联合组治疗4周后餐后饱胀不适、早饱感、上腹痛、上腹烧灼感、上腹胀和恶心症状总有效率分别为88.4%,76.9%,72.9%,61.8%,86.7%和81.7%,餐后饱胀不适、早饱感、上腹痛、上腹胀和恶心症状改善明显优于治疗A组和治疗B组(P<0.05)。3组上腹部烧灼感症状改善差异无统计学意义(P>0.05)。治疗A组、治疗B组和联合组治疗4周后总体症状总有效率分别为60.2%,61.1%,78.8%,联合组显著优于其他两组(P<0.05)。治疗A组、治疗B组和联合组总不良反应发生率分别为1.8%,0.9%和1.8%(P=0.776),均较轻。结论曲美布汀联合莫沙必利可明显改善功能性消化不良患者的症状,且不良反应少。

Objective To evaluate the efficacy and safety of trimebutine combined with mosapride on functional dyspepsia. Methods Patients with functional dyspepsia were randomly divided into three clinical groups. Group A （n=116） received 0.2 g trimebutine after meal,group the drug combination B （n=116） received 5 mg mosapride before meal,and the drug combination group （n=115） received 0. 2 g trimebutine after meal plus 5 mg mosapride before meal. All medications were taken orally three times daily for 4 weeks. Improvement in clinical symptoms and adverse reactions in each group were evaluated at the end of study. Results A total of 339 patients among 347 enrollees completed the treatment and follow-up. The clinical efficacy on postprandial fullness, early satiation, epigastric pain, epigastric burning, upper abdominal bloating and nausea were 88. 4%,76. 9%,72. 9%,61. 8%,86. 7% and 81. 7%,respectively in the drug combination group after 4-week treatment,which were superior to those in group A or B （P〈0. 05） except for epigastric burning. The total effective rate of the drug combination group was 78. 8%,significantly higher than the other two groups （P〈0. 05）. The total incidence of side effects in the drug combination group was 1. 8%,similar to that of group A and B （1. 8% and 0. 9%,respectively, P =0. 776）. Conclusion Trimebutine combined with mosapride is safe and effective for improving symptoms in functional dyspepsia.