六味安消胶囊联合枯草二联杆菌胶囊治疗便秘型肠易激综合征的疗效研究

Efficacy of Liuwei anxiao capsule combined with probiotics in treatment of constipation-predominant irritable bowel syndrome

目的 评估六味安消胶囊联合微生态制剂枯草二联杆菌胶囊治疗便秘型肠易激综合征（IBS）的效果和安全性.方法 采用完全随机方法将100例便秘型IBS患者分为治疗组和对照组,各50例.治疗组给予六味安消胶囊,4粒/次,3次/d;枯草二联杆菌胶囊500 mg/次,3次/d.对照组给予莫沙必利,5mg次,3次/d,餐前15～30 min服用.试验期为6周：1周基线期,4周治疗期,1周随访期,对患者全部IBS症状进行总体评估,对患者每个IBS参数的改善程度以及安全性进行评估.结果 治疗后治疗组和对照组患者的大便性状评分均比治疗前明显改善[（4.34±1.00）分比（1.56±0.61）分,（3.28±0.67）分比（1.64±0.63）分,均P＜0.05].2组治疗前后大便评分增加值比较差异有统计学意义（P＜0.05）.治疗组和对照组症状总积分治疗前后自身比较差异有统计学意义[（6.72±1.43）分比（ 13.30±1.34）分,（9.10±1.94）分比（13.28±1.43）分,均P＜0.05],且治疗组症状改善较对照组更明显（P＜0.05）.治疗组和对照组生活质量评价总评分治疗前后自身比较差异有统计学意义[（7.72±1.43）分比（19.30±1.34）分,（15.10±1.94）分比（19.28±1.43）分,均P＜0.05],且治疗组对生活质量改善更明显（P＜0.05）.安全性分析结果显示,2组间不良事件、不良反应等指标的差异均无统计学意义（P＞0.05）.结论 六味安消胶囊联合枯草二联杆菌胶囊能有效改善便秘型IBS患者的症状,效果稳定,并且具有良好的安全性和耐受性.

Objective To evaluate the clinical therapeutic effects and safety of Liuwei anxiao capsule combined with probiotics（ bacillus subtilis and enterococcus faecim,Medilac-s） in treating constipation-predominant irritable bowel syndrome（IBS）.Methods One hundred patients who met the Rome Ⅲ criteria for constipation-predominant irritable bowel syndrome （C-IBS） were divided into treatment group and control group randomly （50 patients in each group）.Patients in treatment group took Liuwei anxiao （4 caps,tid） and Medilac-s （500 mg,rid） ;control group took mosapride citrate （5 mg,tid） for 4 weeks.The study consisted of a 1-week baseline period,a 4-week randomized and control treatment period,followed by a 1-week withdraw period.Efficacy was assessed by patient＇s perception of overall symptoms of C-IBS,improvement degree of individual constipation-predominant IBS variable,safety of Liuwei anxiao capsule and Medsilac-s.Results Stool score of treatment group and control group after treatment improved significantly[ （4.34 ± 1.00 ） scores vs （ 1.56 ± 0.61 ） scores,（ 3.28 ± 0.67 ） vs （ 1.64 ± 0.63 ） scores,P 〈0.05 ],showing a statistically significant difference between two groups（ P 〈 0.05 ）.The symptom score of the two groups patients had significant differences between the two groups before treatment and after treatment [ （6.72 ± 1.43 ） scores vs （ 13.30 ± 1.34） scores,（ 9.10 ± 1.94 ） scores vs （ 13.28 ± 1.43 ） scores,P 〈0.05 ].The changes of treatment group were more significant than those of control group.Likewise,the scales of life quality of treatment group had a significant improvement compared with control group [ （ 7.72 ± 1.43 ） scores vs （ 19.30 ± 1.34） scores,（ 15.10 ± 1.94） scores vs （ 19.28 ± 1.43 ） scores,P 〈 0.05 ].Safety analysis indicated that there were no significant differences between two groups regarding side-effects and other examining indexes.Conclusions Liuwei anxiao capsule combined with probiotics（Medilac-s） is an effective and stable to treat constipation-oredominant IBS.It has good safety as well as tolerability.