补脾益肠丸治疗腹泻型肠易激综合征的临床随机对照研究

Efficacy of Bupiyichang pills on diarrhea-predominant irritable bowel syndrome: A double-blinded randomized controlled trial

[目的]评价补脾益肠丸(BPYC)治疗腹泻型肠易激综合征(IBS-D)的疗效和安全性。[方法]采用多中心、随机、双盲双模拟、平行对照临床试验设计。在2013年12月~2015年6月,共收集360例IBS-D患者随机分为BPYC组、匹维溴铵组和BPYC+匹维溴铵组3组。3组治疗疗程均为4周。主要疗效指标为患者腹痛程度评分,次要疗效指标为患者腹泻频率、大便性状评分和生活质量评分(IBS-QOL)。分别在治疗前基线时、治疗2周后、治疗4周后进行评价。[结果]3组患者经过4周治疗后,腹痛程度、腹泻频率、大便性状和生活质量均较治疗前明显缓解,组内比较治疗前与治疗后差异均有统计学意义(P<0.01)。治疗后3组组间比较,腹痛程度(P>0.05)、腹泻频率(P>0.05)、大便性状(P>0.05)和生活质量评分(P>0.05)比较差异均无统计学意义。3组均无与药物相关的严重不良事件发生。[结论]BPYC治疗IBS-D具有良好的临床疗效和安全性。BPYC在缓解腹痛、腹泻、便质及改善生活质量方面与匹维溴铵相比,治疗效果相当。BPYC联合匹维溴铵治疗IBS-D并不能增加临床疗效。

[Objective]To evaluate the the efficacy and safety of Bupiyichang pills（BPYC）for patients with diarrhea-predominant irritable bowel syndrome（IBS-D）.[Methods]The total of 360 participants with IBS-D were randomised to 3 groups between December 2013 and June 2015.A group：provision of BPYC（6 g,Tid）and simulant pinaverium bromide（50 mg,Tid）;B group：provision of pinaverium bromide（50 mg,Tid）and simulant BPYC（6 g,Tid）;C group：provision of pinaverium bromide（50 mg,Tid）and BPYC（6 g,Tid）,for 4 consecutive weeks.Primary outcome was abdominal pain severity,secondary outcomes were stool frequency,stool consistency and quality of life.They were measured at baseline,week 2 and 4.[Results]When analyzing data within groups,significant improvements of all above（abdominal pain,abnormalities in stool frequency or form and quality of life）in the three groups were observed after treatment（All P=0.000）.After treatment no significant difference in effect of three groups on abdominal pain（P=0.5498）,stool frequency（P=0.3692）,stool consistency（P=0.7750）and quality of life（P=0.3270）.There were no serious adverse in each group during the treatment period.[Conclusion]BPYC was safe and effective in the management of IBS-D.There was no difference between BPYC and pinaverium bromide in relieving the symptoms of abdominal pain,abnormalities in stool frequency or form and improving quality of life.Combination of BPYC and pinaverium bromide did not increase the efficacy.