目的:研究中药肠舒颗粒联合认知-行为疗法(CBT)治疗腹泻型肠易激综合征肝郁脾虚证的临床疗效及安全性。方法:将80例腹泻型肠易激综合征肝郁脾虚证患者随机分为2组各40例。治疗组采用肠舒颗粒联合CBT治疗,对照组采用匹维溴铵片口服治疗,疗程均为1个月,观察比较2组临床疗效和安全性。结果:总有效率治疗组为92.5%,对照组为76.3%,2组比较,差异有统计学意义(P〈0.05);2组治疗后主要症状积分均较治疗前明显降低,且治疗组改善优于对照组,差异均有统计学意义(P〈0.05);2组生活质量评分比较,治疗组在焦虑不安、健康忧虑、挑食、社会功能及人际关系方面优于对照组,差异有统计学意义(P〈0.05)。结论:肠舒颗粒联合CBT治疗腹泻型肠易激综合征肝郁脾虚证在降低主要症状积分、改善患者生活质量及临床疗效方面优于匹维溴铵片治疗,且不良反应轻,是安全有效的方法,值得推广。
Objective :To investigate the clinical efficacy and safety of Changshu granules combined with cogni- tive- behavioral therapy(CBT) in the treatment of diarrhea- predominant irritable bowel syndrome with liver de- pression and spleen deficiency. Methods : A total of 80 patients suffering from diarrhea - predominant irritable bowel syndrome with liver depression and spleen deficiency were randomly and equally divided into two groups. The treat- ment group was treated with Changshu granules combined with CBT, and the control group was given oral adminis- tration of pinaverium bromide tablets. Both groups were treated for one month, and the clinical effect and safety were then compared. Results:The overall response rate was 92. 5% in the treatment group and 76.3% in the control group, with a significant difference between the two groups (P 〈 0. 05 ). Both groups showed a significant improve- ment in main symptom scores, and the treatment group had a significantly greater improvement than the control group ( P 〈 0. 05 ). The treatment group had a significantly better outcome than the control group in living quality scores of anxiousness,health concern, unbalanced diet, social function, and interpersonal relationship (P 〈 0.05). Conclusion : For diarrhea - predominant irritable bowel syndrome with liver depression and spleen deficiency, Chang- shu granules combined with CBT have better clinical efficacy than pinaverium bromide tablets in alleviating main symptoms and improving patients' quality of life, with little adverse effect;therefore it should be recommended in clinical practice.