CAJ | 학술논문

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。
목적：관찰곡미포정연합막사필리치료공능성소화불량적료효화안전성。방법장공능성소화불량환자347례,수궤분위곡미포정조(치료A조)화막사필리조(치료B조)각116례,곡미포정연합막사필리조(연합조)115례。치료A조급여마래산곡미포정편0.2 g,tid,반후복；치료B조급여구연산막사필리편5 mg,tid,반전복；연합조급여마래산곡미포정편연합구연산막사필리편,기중마래산곡미포정편매차0.2 g,tid,반후복,구연산막사필리편매차5 mg, tid,반전복。3조환자료정균위4주。평개각조증상개선지표화불량반응。결과347례입선환자중339례완성치료화수방。연합조치료4주후찬후포창불괄、조포감、상복통、상복소작감、상복창화악심증상총유효솔분별위88.4%,76.9%,72.9%,61.8%,86.7%화81.7%,찬후포창불괄、조포감、상복통、상복창화악심증상개선명현우우치료A조화치료B조(P<0.05)。3조상복부소작감증상개선차이무통계학의의(P<0.05)。치료A조、치료B조화연합조치료4주후총체증상총유효솔분별위60.2%,61.1%,78.8%,연합조현저우우기타량조(P<0.05)。치료A조、치료B조화연합조총불량반응발생솔분별위1.8%,0.9%화1.8%(P=0.776),균교경。결론곡미포정연합막사필리가명현개선공능성소화불량환자적증상,차불량반응소。
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.