马来酸曲美布汀治疗肠易激综合征的疗效和安全性研究

Efficacy and Safety Use of Trimebutine Maleate in Treatment of Irritable Bowel Syndrome

背景肠易激综合征(IBS)是一种常见的肠道功能性疾病,曲美布汀是一种具有胃肠道运动调节作用的药物,已广泛应用于IBS的治疗。目的评估马来酸曲美布汀治疗IBS的疗效和安全性。方法采用前瞻性、随机、对照、多中心临床研究,将符合罗马Ⅱ标准的79例便秘型IBS(C鄄IBS)患者和81例腹泻型IBS(D鄄IBS)患者分别随机分为马来酸曲美布汀组和匹维溴铵组。研究包括2周基线期、4周治疗期和随后的2周随访期。患者在治疗期内口服马来酸曲美布汀(200mgtid)或匹维溴铵(50mgtid)。主要疗效指标为每周总体症状的评分,次要疗效指标包括每周便秘/腹泻的严重程度评分、腹部胀气和其他IBS症状的严重程度评分。结果马来酸曲美布汀治疗后,C鄄IBS和D鄄IBS患者的总体症状评分均显著下降,分别由基线期的1.9和1.8下降至治疗期结束时的1.1和0.6(P<0.01),次要疗效指标也均显著改善;各症状的改善程度与匹维溴铵组比较均无显著差异。研究期间未发现明显不良反应。结论马来酸曲美布汀是一种安全、有效的缓解IBS症状的药物。

Background: Irritable bowel syndrome (IBS) is a common functional intestinal disorder. Trimebutine maleate has modulating effect on gastrointestinal motility and is widely used currently. Aims: To evaluate the efficacy and safety use of trimebutine maleate in the treatment of IBS patients. Methods: A prospective, randomized controlled, multicenter and clinical trial was designed. Seventy-nine constipation-predominant IBS (C-IBS) patients and 81 diarrhea-predominant IBS (D-IBS) patients consistent with Rome Ⅱ criteria were enrolled and divided randomly into trimebutine maleate group and pinaverium bromide group, respectively. This study consisted of a 2-week baseline period, a 4-week randomized treatment period with trimebutine maleate 200 mg tid or pinaverium bromide 50 mg tid, followed by a 2-week withdrawal follow-up observation period. The main efficacy variable was assessed by perception of overall symptom of IBS during the previous weeks. Secondary efficacy variables included severity of constipation/diarrhea during the previous weeks, abdominal distention and other IBS symptoms. Results: After treated with trimebutine maleate, the overall symptom score in C-IBS patients dropped significantly from 1.9 to 1.1 (P<0.01), and also decreased significantly from 1.8 to 0.6 in D-IBS patients (P<0.01). Other related symptoms were also ameliorated obviously. No significant difference was seen in the improvement of each IBS symptom between the two groups. No adverse effect was found in this study. Conclusions: Trimebutine maleate is an effective and safe medicine for alleviation of IBS symptoms.