健脾疏肝固本方治疗肝郁脾虚型腹泻型肠易激综合征多中心随机双盲双模拟对照研究

Clinical study on treating liver depression and spleen deficiency type irritable bowel syndrome with diarrhea patients by Jianpi Shugan Guben Formula:A multicenter randomized,double-blind,double-simulated controlled study

目的:评价健脾疏肝固本方治疗肝郁脾虚型腹泻型肠易激综合征(IBS-D)的临床疗效。方法:260例肝郁脾虚型IBS-D患者随机分为治疗组和对照组,每组130例。治疗组给予口服健脾疏肝固本方+匹维溴铵模拟片;对照组口服匹维溴铵片+健脾疏肝固本方模拟剂;两组疗程均为4周,停药后1、3个月随访。采用IBS症状尺度表(IBS-SSS)、中医证候疗效评分表(TCM-PES)、IBS大便性状问卷(IBS-DSQ)、IBS生活质量量表(IBSQOL),评估治疗后临床疗效及生活质量。结果:治疗4周后及停药1、3个月,两组患者IBS-SSS积分、TMC-PES积分、IBS-DSQ积分均较治疗前显著降低(P<0.01),IBS-QOL评分较治疗前显著升高(P<0.01),且治疗组IBS-SSS积分、TCM-PES积分、IBS-DSQ积分均低于对照组(P<0.05)。治疗4周后治疗组IBS-QOL躯体意念维度改善优于对照组(P<0.05),停药1个月治疗组IBS-QOL焦虑不安、行为障碍、躯体意念、健康忧虑、社会功能、人际关系6个维度改善优于对照组(P<0.05),停药3个月,治疗组8个维度改善均优于对照组(P<0.05)。两组试验期间均未发生不良事件。结论:健脾疏肝固本方治疗肝郁脾虚型IBS-D具有良好的临床疗效及安全性,能有效缓解患者腹痛、腹泻及改善生活质量,且疗效稳定、持续性强。

Objective:To evaluate the clinical efficacy of Jianpi Shugan Guben Formula in the treatment of liver depression and spleen deficiency type irritable bowel syndrome with diarrhea(IBS-D).Methods:A total of 260 patients with IBS were divided into treatment group and control group according to random number table,130 cases in each group.The treatment group was given oral Jianpi Shugan Guben Formula+Piviparium Bromide Simulation Tablet;Control group was given Piveronium Bromide Tablet+Jianpi Shugan Guben Formula simulation agent;The treatment course of both groups was 4 weeks,followed up 1 month and 3 months after drug withdrawal.IBS Symptom Severity Scale(IBS-SSS),traditional Chinese Medicine pattern curative effect scoring system(TCM-PES),IBS Defecation State Questionnaire(IBS-DSQ),IBS Quality of Life Questionnaire(IBS-QOL),evaluate the clinical efficacy and quality of life after treatment.Results:After 4 weeks of treatment and during 1 and 3 months of drug withdrawal,the IBS-SSS score,TMC-PES score and IBS-DSQ score of the two groups were significantly decreased compared with those before treatment(P<0.01),the IBS-QOL score was significantly higher than that before treatment(P<0.01),the IBS-SSS score,TMC-PES score and IBS-DSQ score of the treatment group were lower than those of the control group(P<0.05).After 4 weeks of treatment,the treatment group was better than the control group in IBS-QOL body ideation dimension improvement(P<0.05),after one month of drug withdrawal,the treatment group was better than the control group in the improvement of six dimentions such as IBS-QOL anxiety,behavior disorder,body ideation,health worry,social function and interpersonal relationship(P<0.05),after three months of drug withdrawal,the treatment group was better than the control group in the improvement of eight dimensions(P<0.05).There were no adverse events in both groups during the test.Conclusion:Jianpi Shugan Guben Formula has good clinical efficacy and safety in the treatment of liver depression and spleen deficiency type IBS-D,and can effectively relieve abdominal pain,diarrhea and improve the quality of life of patients,and the effect is stable and persistent.