马来酸曲美布汀治疗功能性消化不良与腹泻型肠易激综合征重叠的随机对照研究  

A randomized and case-control clinical study on trimebutine maleate in treating functional dyspepsia coexisting with diarrhea-dominant irritable bowel syndrome

作　　者：钟英强[1] 朱军[2] 郭佳念[1] 颜蓉[1] 李惠君[1] 林燕华[1] 曾志勇[1] 

机构地区：[1]中山大学附属第二医院消化内科,广州510120 [2]中山大学附属第二医院药学部,广州510120

出　　处：《中华内科杂志》2007年第11期899-902,共4页Chinese Journal of Internal Medicine

摘　　要：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 drug reaction of trimebutine maleate in treating patients with functional dyspepsia （FD） coexisting with diarrhea dominant irritable bowel syndrome （IBS-D）. Methods 129 patients were enrolled in this randomized, case-control and prospective study and divided into 3 groups. Group A was treated with trimebutine maleate and bacillus licheniformis, Group B with trimebutine maleate and Group C with bacillus licheniformis. The symptoms of the patients were described with grading score and efficacy of treatment assessed according to the changes of grading score of symptoms. Results There was a significant decrease in the scores of postprandial fullness （4. 55 ± 0. 85, 1.26±0.52;4.36±0.66,1.48±0.61）, early satiation （4.05 ±0.96,1.01 ±0.51;3.89±0.81,1.25 ± 0. 76 ）, abdominal pain （ 9. 26 ± 0. 68,0. 68 ± 0. 43 ; 9.57 ± 1.60,0.76 ± 0. 54 ） and total symptom score （20. 00 ± 1.25,3.06 ± 0. 91 ; 19. 05 ± 2. 28,3. 89 ± 2. 12） before and after treatment in Group A and B （P 〈0. 05）, but there was no such significance in Group C （P 〉0. 05）. There was a significant decrease in diarrhea score before and after treatment in the 3 groups （ A：4. 78 ± 0.76,0. 65 ± 0. 53 ; B：4. 13 ± 0. 65, 1.25 ± 0. 62 ; C ：4. 65 ± 0. 88,1.45 ± 0. 70） （ P 〈 0. 05 ）. After treatment for 4 weeks, there was significant difference in the scores of postprandial fullness, early satiation, abdominal pain and total symptom score as well as the effective rate of every symptom and total effective rate between Group A or B and Group C （P 〈0. 05）. The ratio of cost and effect was 4. 07, 1.19 and 6. 65 in Group A, B and C respectively, the Group B being the best. The rate of adverse drug reaction was 22. 9% and 23.7% in Group A and B, and the main adverse drug reactions were mild thirst and constipation. Conclusions In treating patients with functional dyspepsia coexisting with diarrhea dominant irritable bowel syndrome, trimebutine maleate has

关 键 词：消化不良 结肠疾病 功能性 曲美布汀 地衣芽孢杆菌 

分 类 号：R57[医药卫生—消化系统] R574[医药卫生—内科学]