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目的观察马来酸曲美布汀片(曲美布汀)治疗功能性消化不良(FD)与腹泻型肠易激综合征(IBS-D)重叠的疗效和不良反应。方法采用随机、病例对照的前瞻性研究,129例患者随机分为 A 组(曲美布汀和地衣芽孢杆菌)、B 组(曲美布汀)和 C 组(地衣芽孢杆菌)。各症状采用分级记分进行描述,疗效评价参照症状积分的变化。结果 A、B 组治疗前后的评分,分别为腹胀[A 组(4.55±0.85)分,(1.26±0.52)分;B 组(4.36±0.66)分,(1.48±0.61)分]、早饱[A 组(4.05±0.96)分,(1.01±0.51)分;B 组(3.89±0.81)分,(1.25±0.76)分]、腹痛[A 组(9.26±0.68)分,(0.68±0.43)分;B 组(9.57±1.60)分,(0.76±0.54)分],症状总积分[A 组(20.00±1.25)分,(3.06±0.91)分;B 组(19.05±2.28)分,(3.89±2.12)分],治疗后较治疗前均有显著下降(P<0.05),而 C 组治疗前后差异无统计学意义(P>0.05);3组治疗前后的腹泻评分[A 组(4.78±0.76),(0.65±0.53);B 组(4.13±0.65),(1.25±0.62);C 组(4.65±0.88),(1.45±0.70)]均有显著性下降(P<0.05)。治疗4周后,腹胀、早饱、腹痛的评分和症状总积分,A、B 组与 C 组比较,差异有统计学意义(P<0.05)。A、B 组的各症状的疗效和总疗效均优于 C 组(P<0.05)。3组的费用-效果比(C/E)分别为4.07、1.19、6.65,以 B 组最佳。A、B 组的不良反应发生率分别为22.9%和23.7%,主要为轻度的口干和便秘。结论曲美布汀治疗 FD 与 IBS-D 重叠的患者,具有疗效高,价席,不良反应少的特点。
Objective To observe the efficacy and adverse reactions of trimebutine maleate tablets (Trimebutine) in the treatment of overlap of functional dyspepsia (FD) and diarrhea-predominant irritable bowel syndrome (IBS-D). Methods A randomized, case-control prospective study of 129 patients randomized to A (Trimebutine and Bacillus licheniformis), B (Trimebutine) and C (Bacillus licheniformis). The symptoms were graded scoring description, efficacy evaluation reference symptom score changes. Results The scores before and after treatment in group A and group B were abdominal distension (4.55 ± 0.85 points and 1.26 ± 0.52 points respectively in group A, 4.36 ± 0.66 points and 1.48 ± 0.61 points in group B) Group A (4.05 ± 0.96), (1.01 ± 0.51); Group B (3.89 ± 0.81), (1.25 ± 0.76), abdominal pain [Group A (9.26 ± 0.68), (0.68 ± 0.43) ; Group B (9.57 ± 1.60), (0.76 ± 0.54) points, total symptom score [20.00 ± 1.25 points in group A (3.06 ± 0.91), (19.05 ± 2.28) points in group B, (3.89 ± (P <0.05). However, there was no significant difference between before and after treatment in group C (P> 0.05). The score of diarrhea before and after treatment in group A [4.78 ± 0.76 ), (0.65 ± 0.53) in group B (4.13 ± 0.65) and (1.25 ± 0.62) in group C (4.65 ± 0.88 and 1.45 ± 0.70 respectively) (P <0.05). After 4 weeks of treatment, the total score of abdominal distension, early fullness and abdominal pain and the total score of symptoms were statistically significant (P <0.05). The curative effect and total curative effect of each symptom of group A and group B were better than group C (P <0.05). The cost-effect ratio (C / E) of the three groups were 4.07, 1.19 and 6.65, respectively, which was the best in group B. Adverse reactions in groups A and B were 22.9% and 23.7% respectively, mainly mild dry mouth and constipation. Conclusion Trimebutine treatment of FD and IBS-D overlap in patients with high efficacy, the price of seats, fewer adverse reactions.