美沙拉嗪联合马来酸曲美布汀治疗肠易激综合征患者的临床疗效观察

摘要

目的 评估美沙拉嗪联合马来酸曲美布汀治疗肠易激综合征(IBS)患者的临床疗效.方法 根据罗马Ⅲ诊断标准纳入2014年10月至2016年6月在上海市嘉定区中心医院就诊的腹泻型IBS(IBS-D)和便秘型IBS(IBS-C)患者各40例.40例IBS-D患者随机分为美沙拉嗪+马来酸曲美布汀组和马来酸曲美布汀组,每组各20例;40例IBS-C患者随机分为美沙拉嗪+马来酸曲美布汀组和马来酸曲美布汀组,每组各20例.同期选择20名健康体检者作为正常对照.治疗前后均使用肠易激严重程度评分系统(IBSSS)和医院焦虑抑郁量表(HADS)评估患者的临床疗效和情绪障碍的严重程度.结果 研究过程中未观察到严重的药物相关不良反应.在IBS-D患者中,美沙拉嗪+马来酸曲美布汀组经过4周治疗后,IBSSS总分由基线时的(194.5±62.6)分下降至(136.3±47.2)分(P<0.000 1),而马来酸曲美布汀单药组则由治疗前的(207.3±49.2)分下降至治疗后的(197.5±47.8)分(P=0.01);在IBS-C患者中,美沙拉嗪+马来酸曲美布汀组经过4周治疗后,IBSSS总分由基线时的(245.8±70.4)分下降至(231.3±65.0)分(P=0.005).基线状态时,IBS患者组的焦虑和(或)抑郁评分均高于健康对照组(P<0.000 1).在IBS-D患者中,美沙拉嗪+马来酸曲美布汀组经过4周治疗后,焦虑和抑郁评分分别由基线时的(11.9±4.1)分下降至(11.3±4.1)分(P=0.019)、(13.6±4.7)分下降至(12.5±4.5)分(P=0.002 6).%Objective This paper intends to evaluate the clinical effects of mesalazine and trimebutine maleate on irritable bowel syndrome patients (IBS).Methods Eighty patients with IBS diagnosed by Rome Ⅲ criteria and 20 healthy controls were enrolled from October 2014 to June 2016 in Shanghai Jiading District Central Hospital.Forty patients with IBS with diarrhea (IBS-D) were randomly divided into trimebutine maleate only (n=20) and mesalazine + trimebutine maleate (n=20) group.Forty patients with IBS with constipation (IBS-C) were also randomly divided into trimebutine maleate only (n=20) and mesalazine + trimebutine maleate (n=20) group.Irritable bowel severity scoring system (IBSSS) and hospital anxiety and depression scale (HADS) were used to evaluate the clinical efficacy and emotional disorderbetween different groups before and after treatment.Results No serious drug-related adverse events were reported during the study.In IBS-D patients, the total scores of the IBSSS inmesalazine + trimebutine maleate group and trimebutine maleate group were 194.5±62.6 and 207.3±49.2 at baseline, respectively.After treatment, they were 136.3±47.2 and 197.5±47.8, respectively.The difference remained statistically significant (P<0.000 1 and P=0.01).However, in IBS-C patients, the total scores of the IBSSS inmesalazine + trimebutine maleate group before and after treatment were 245.8±70.4 and 231.3±65.0, respectively (P=0.005).At baseline, the HADS scores were significantly higher in IBS patients than those in healthy groups (P<0.000 1).In IBS-D patients, the anxiety and depression scores of mesalazine +trimebutine maleategroup at baseline were 11.9±4.1 and 13.6±4.7, respectively.However, after a 4-week treatment, those scores were significantly lower (11.3±4.1, P=0.019;12.5±4.5, P=0.002 6).Conclusions IBS patients have psychological abnormalities.Mesalazine combined with trimebutine maleate therapy may improve clinical symptoms and psychological abnormalities in IBS patients, especially in IBS-D.