莫沙必利联合氟哌噻吨美利曲辛治疗便秘型肠易激综合征的临床观察

Clinical Observation on Mosapride Combined with Flupentixol-melitracen in Treating Irritable Bowel Syndrome with Constipation

背景：肠易激综合征（IBS）是一种临床常见的功能性肠病,目前治疗方法虽较多,但疗效不甚理想.目的：观察莫沙必利联合抗焦虑抑郁药氟哌噻吨美利曲辛治疗便秘型IBS（IBS-C）的疗效和安全性.方法：68例IBS-C患者随机分人联合治疗组（35例）和对照组（33例）,对照组口服枸橼酸莫沙必利胶囊5 mg tid,联合治疗组在对照组的基础上加用氟哌噻吨美利曲辛片0.5 mg＋10 mg qn,疗程4周.治疗前后行IBS-C症状评分和精神心理量表HAMA、HAMD、SCL-90评分,根据治疗后症状总评分改善情况评价临床疗效,观察治疗过程中不良事件发生情况.结果：4周疗程结束后,两组腹痛/不适、排便频率、粪便性状评分和症状总评分以及各精神心理量表评分均较治疗前显著降低（P〈0.05）,联合治疗组降低更为明显,总有效率显著高于对照组（88.6%对75.8%,P＜0.05）.治疗过程中未发生严重不良事件.

Background： Irritable bowel syndrome （IBS） is a commonly seen functional bowel disorder. There are many treatment modalities for IBS, but none of them has a perfect efficacy. Aims： To investigate the efficacy and safety of mosapride combined with flupentixol-melitracen, an antianxiety and antidepressant agent, in treating IBS with constipation （IBS-C）. Methods： In a randomized trial, 68 cases of IBS-C were divided into control group （n =33） and combination group （n=35）, receiving oral mosapride citrate capsule 5 mg rid alone or combined with flupentixol-melitracen tablets, 0.5 mg＋10 mg qn, respectively for 4 weeks. Scores of clinical symptoms and three mental scales （HAMA, HAMD and SCL-90） were assessed before and after treatment, the clinical efficacy was estimated by analyzing the changes of total symptoms score. Adverse events during the treatment course were observed. Results： Compared with those before treatment, the scores of abdominal pain/discomfort, stool frequency, stool form and total symptoms, as well as the scores of three mental scales, were significantly decreased after 4-week treatment in both the two groups （P〈0.05）, especially in combination group. The overall efficacy rate of combination group was superior to that of control group （88.6% vs. 75.8%, P〈0.05）. No severe adverse events were observed during the treatment course. Conclusions： Mosapride combined with flupentixol-melitracen is effective in relieving the clinical symptoms and improving the mental status of IBS-C patients without obvious side effects, and is worthy to be used widely in clinical practice.