痛泻安肠方治疗腹泻型肠易激综合征肝郁脾虚证随机对照、双盲双模拟的临床研究
Randomized controlled,double-blind and double-simulation clinical study of Tongxie Anchang Formula in the treatment of diarrhea irritable bowel syndrome with liver stagnation and spleen deficiency
焦瑶 1陈慧慧 1张烨 2薛晓轩 2毛堂友 2韩海啸 2陈润花 2胡立明 2李军祥 2袁亚利 1史瑞 2谢春娥2
作者信息
- 1. 北京中医药大学,北京 100029
- 2. 北京中医药大学东方医院,北京 100078
- 折叠
摘要
目的:明确痛泻安肠方对肝郁脾虚证腹泻型肠易激综合征(IBS-D)的疗效.方法:纳入2019年11月至2022年1月就诊于北京中医药大学东方医院的IBS-D肝郁脾虚证患者72例,随机分为治疗组和对照组,各36例,治疗组给予痛泻安肠方配方颗粒合匹维溴铵片模拟剂口服,对照组给予痛泻安肠方配方颗粒模拟剂合匹维溴铵片口服,均治疗4周,观察主要结局指标(总体有效率、主要症状)、次要结局指标[肠易激综合征严重程度评测(IBS-SSS)、中医证候量表、肠易激综合征患者生活质量(IBS-QOL)]和安全性指标.结果:治疗组有效率[81.25％(26/32)]优于对照组[66.67％(20/30)],但差异无统计学意义.主要症状中治疗组腹痛总有效率[93.75％(30/32)]显著优于对照组[66.67％(20/30)](P＜0.05).治疗组在改善中医证候各项症状如腹痛、情志抑郁或焦躁易怒、两胁胀满、口渴等方面显著优于对照组(P＜0.05).两组患者治疗后均未诉不适,各理化指标检查正常.结论:痛泻安肠方治疗IBS-D肝郁脾虚证的总体疗效与匹维溴铵相当,在改善腹痛及情志抑郁或焦躁易怒、两胁胀满和口渴等症状方面优于匹维溴铵,药物安全性较高.
Abstract
Objective:To determine the efficacy of Tongxie Anchang Formula on diarrhea irritable bowel syndrome(IBS-D)patients with liver stagnation and spleen deficiency.Methods:Seventy-two patients with liver stagnation and spleen deficiency who visited Dongfang Hospital,Beijing University of Chinese Medicine from November 2019 to January 2022 were included to this study.The patients were randomly divided into the treatment group and the control group,with 36 patients in each group.The patients in the treatment group were given the Tongxie Anchang Formula and Pinaverium Bromide simulant(oral),and the control group was given the Tongxie Anchang Formula simulant and Pinaverium Bromide(oral),treating of 4 weeks.The main outcome indicators(overall effective rate,main symptoms),secondary outcome indicators[assessment of severity of irritable bowel syndrome(IBS-SSS),traditional Chinese medicine syndrome scale,and quality of life for irritable bowel syndrome patients(IBS-QOL)]and safety indexes were observed before and after treatment in both groups.Results:The effective rate in the treatment group was 81.25％(26/32),which was better than that in the control group[66.67％(20/30)],but there was no statistically significant difference between two groups.The overall effective rate of abdominal pain in the treatment group[93.75％(30/32)]was significantly better than that in the control group[66.67％(20/30)](P＜0.05).The treatment group was significantly better than the control group in improving abdominal pain,depression or agitation and irritability,fullness of two fanks,thirst,and so on(P＜0.05).Neither the treatment group nor the control group reported any discomfort after treatment,and all physical and chemical indicators physical and chemical indicators were normal.Conclusion:The overall efficacy of Tongxie Anchang Formula in the treatment of IBS-D with liver stagnation and spleen deficiency is equivalent to Pinaverium Bromide,it is superior to the Pinaverium Bromide in improving abdominal pain,depression or agitation and irritability,fullness of two flanks and thirst,Tongxie Anchang Formula have high safety.
关键词
痛泻安肠方/腹泻型肠易激综合征/肝郁脾虚证/双盲双模拟/临床研究Key words
Tongxie Anchang Formula/Diarrhoeal irritable bowel syndrome(IBS-D)/Liver stagnation and spleen deficiency syndrome/Double-blind and double-simulation/Clinical study引用本文复制引用
出版年
2024
NETL
NSTL
万方数据