乌灵胶囊联合匹维溴铵治疗肠易激综合征的临床研究

Treating Irritable Bowel Syndrome by Wuling Capsule Combined Pinaverium Bromide: a Clinical Research

目的观察乌灵胶囊联合匹维溴铵治疗肠易激综合征(irritable bowel syndrome,IBS)的疗效和安全性。方法 64例IBS患者按随机数字表法分为治疗组(32例)和对照组(32例)。治疗组给予口服乌灵胶囊(0.33 g/粒),1次3粒,每日3次,并联合口服匹维溴铵片(50 mg/片),1次1片,每日3次;对照组仅口服匹维溴铵片(50 mg/片),1次1片,每日3次;两组疗程均为6周。观察两组治疗前后各项IBS症状评分和IBS生活质量评价量表(IBS-Quality of Life,IBS-QOL)评分的变化,应用抑郁自评量表(Self-Rating Depression Scale,SDS)和焦虑自评量表(Self-Rating Anxiety Scale,SAS)进行心理评估,观察患者不良反应发生的情况。结果与对照组比较,治疗组腹痛、大便次数、大便性状症状改善,积分变化率高于对照组,差异有统计学意义(P<0.05);治疗组IBS-QOL烦躁不安、身体意象、健康忧虑、饮食限制的评分改善,评分变化率高于对照组,差异有统计学意义(P<0.05);治疗组SDS和SAS的评分改善,评分变化率高于对照组,差异有统计学意义(P<0.05)。两组患者均未发现严重不良反应。结论乌灵胶囊联合匹维溴铵治疗IBS,能够进一步改善IBS患者腹痛及排便症状,减轻抑郁焦虑,且安全性高。

Objective To evaluate the efficacy and safety of Wuling Capsule combined with Pinaverium Bromide in treatment of irritable bowel syndrome （IBS）. Methods Sixty-four IBS patients were randomized into two groups, the treatment group and the control group, 32 in each group. Patients in the treatment group took Wuling Capsule （0.33 g/capsule, 3 times per day） and Pinaverium Bromide （50 mg/tablet, one tablet each time, 3 times per day）, while those in the control group only took Pinave- rium Bromide （50 rag/tablet, one tablet each time, 3 times per day）. The therapeutic course for all was 6 weeks. IBS symptom score questionnaire, IBS-Quality of Life （IBS-QOL）, Self-Rating Depression Scale （SDS）, and Self-Rating Anxiety Scale （SAS） were assessed before and after treatment. Adverse reac- tions were also observed. Results The improvement of abdominal pain, stool frequency, and stool properties, as well as changing rates of integrals were significantly higher in the treatment group than in the control group （P 〈0, 05）. The improvement of dysphoria, body image, concerns for health, and dieta- ry restriction of IBS-QOL, as well as changing rates of integrals were significantly higher in the treatment group than in the control group （P 〈0.05）. The improvement of SDS and SAS, as well as changing rates of integrals were significantly higher in the treatment group than in the control group （P 〈0.05）. No se- vere adverse reaction occurred in either group. Conclusion Combination therapy of Wuling Capsule and Pinaverium Bromide could improve abdominal pain and defecation, attenuate depression and anxiety of IBS patients with higher safety.