N-乙酰氨基葡萄糖治疗腹泻型肠易激综合征多中心临床研究

目的 评估N-乙酰氨基葡萄糖治疗腹泻型肠易激综合征(D-IBS)的有效性和安全性.方法 采用多中心、随机、双盲、安慰剂对照设计.入选受试者共430例,试验组323例、对照组107例.经2周基线期后,试验组连续4周三餐前予N-乙酰氨基葡萄糖100 mg口服,对照组则给予安慰剂,停药后随访2周.主要疗效指标为总体感觉视觉模拟评分(VAS评分)和总体症状感觉评分,次要疗效指标包括腹部不适/疼痛、腹泻严重程度,胃肠胀气程度、排便次数、粪便性状、排便急迫感、紧急用药情况.同时记录试验期间的不良事件.结果 治疗4周后,试验组主要疗效指标改善,明显优于对照组(P<0.01),两组有效率分别为65.16%、34.29%.在治疗第1周后,两组除使用止泻药次数差异无统计学意义外(P=1.00),其他次要疗效指标的改善试验组均优于对照组(P<0.01).试验组不良反应发生率为0.96%,对照组为0.95%,两组间差异无统计学意义(P=1.00).结论 N-乙酰氨基葡萄糖通过改善肠黏膜局部的生态环境、避免肥大细胞激活等机制,治疗D-IBS有效而安全.

Treatment of diarrhea-predominant irritable bowel syndrome with N-acetyl-D-glucosamine: A randomized, double-blind, placebo-controlled multi-center study Coorperative group.

Objective To evaluate the efficacy and safety of N-acetyl-D-glucosamine in treatment of diarrhea-predominant irritable bowel syndrome (D-IBS). Methods A multi-center, randomized, double-blind, placebo-controlled clinical study was performed in 430 patientswith D-IBS. After 2-week baseline period, eligible subjects were randomly either received 100 mg of N-acetyl-D-glucosamine (treated group,n=323) or placebo (control group,n= 107) 3 times a day for consecutive 4 weeks, followed by 2-week withdrawal follow-up. The major parameters were assessed by visual analogue scale (VAS) score and Common Symptom Sensation score. The minor parameters included abdominal pain or discomfort, severity of diarrhea, bloating, urgency, defecation frequencies with consistency per bowel movement which was judged by bristol stool scale and utilization of Smect. The evidence of adverse events was reeoded. Results The major parameters were singnifieantly improved in the treated group with effective rate of 65.16 % at the fourth week of treatment in comparison with control group (effective rate of 34. 29% ,P<0.01). Except the utilization of Smect (P= 1.00), the other minor parameters were significantly improved in treated group compared with control group (P< 0.01) after 1 week treatment. The occurrence of adverse events was 0.96% in the treated group and 0. 95% in the control group (P = 1. 00). Conclusions The results indicate that N-acetyl-D-glucosamine is effective and safe in the treatment of D-IBS by improving ecological environment and preventing activation of mast cells.