抑肝扶脾汤治疗腹泻型肠易激综合征的随机对照临床研究

目的评价抑肝扶脾汤治疗腹泻型肠易激综合征（irritable bowel syndrome with diarrhea， IBS-D）的有效性和安全性。方法将患者按随机数字表法分为治疗组和对照组，每组58例。治疗组给予抑肝扶脾汤治疗，对照组给予口服匹维溴铵片，2组疗程均为4周。分别采用IBS症状尺度表（IBS bowel symptom severity scale， IBS-BSS）、IBS大便性状问卷（IBS defecation state questionnaire， IBS-DSQ）、IBS生活质量问卷（IBS quality of life questionnaire， IBS-QOL）和中医证候疗效评分表（traditional Chinese medicine pattern curative effect scoring system， TCM-PES）评估两组患者治疗后总体临床疗效、大便性状情况、生活质量及中医证候疗效。结果治疗组与对照组IBS-BSS总有效率（分别为82.76%、77.59%）比较，差异无统计学意义（P〉0.05），IBS-BSS总积分比较，治疗组低于对照组（P〈0.05）；两组大便性状总有效率（分别为81.03%、 72.41%）比较，差异有统计学意义（P〈0.05），且治疗组在10天中排便的急迫天数短于对照组（P〈0.05）；两组IBS-QOL总积分、中医证候总有效率（分别为84.48%、70.69%）及中医证侯总积分方面均有改善，且治疗组优于对照组（P〈0.05）。结论抑肝扶脾汤能有效缓解IBS-D肝气乘脾证患者肠道症状，改善大便性状及频率，提高患者生活质量，改善肝气乘脾证候，且有良好的安全性和依从性。

Treating Irritable Bowel Syndrome with Diarrhea Patients by Yigan Fupl Decoction： a Randomized Controlled Trial

Objective To evaluate the efficacy and safety of Yigan Fupi Decoction （YFD） in the treatment of irritable bowel syndrome with diarrhea （IBS-D） patients. Methods A randomized controlled clinical trail was carried out in patients with IBS-D. All patients were randomly assigned to the treatment group （58 cases, treated with YFD） and the control group （58 cases, treated with Pinaverium Bromide Tablet）. The treatment course was 4 weeks for all patients. The total effective rate, the stool property and state, the quality of life （QOL）, and TCM syndrome efficacy were assessed by IBS bowel symptom severity scale （IBS-BSS）, IBS defecation state questionnaire （ IBS-DSQ）, IBS quality of life questionnaire （IBS-QOL）, and traditional Chinese medicine pattern curative effect scoring system （TCM-PES） before and after treatment. Results There was no statistical difference in the total effective rate between the two groups （82.76% vs 77.59%, P 〉0.05）. The treatment group was superior in the total IBS-BSS integral to the control group （P 〈0.05）. The total effective rate of improving the stool property was better in the treatment group than in the control group （81.03% vs 72.41%, P 〈0.05）. Besides, the number of days for emergent defecation among 10 days was less in the treatment group than in the control group （P 〈0.05）. The improvement of the total IBS-QOL integral and the total integral of TCM syndrome were better in the treatment group than in the control group （P 〈0.01 ）. The total effective rate of TCM-PES was better in the treatment group than in the control group （84.48% vs 70.69%, P 〈0.05）. Conclusion YFD was effective in the treatment of IBS-D patients of Gan-qi invading Pi syndrome, and could effectively relieve bowel symptoms, improve the stool property and the defecation frequency, elevate their QOL, and attenuate Gan-qi invading Pi syndrome with favorable safety and compliance.