珍素痛泻要方治疗肝郁脾虚型功能性腹泻的临床疗效观察

Observation on the Clinical Efficacy of Zhen Su Tongxie Prescription for the Treatment of Functional Diarrhea with Liver Depression and Spleen Deficiency Syndrome

【目的】探讨珍素痛泻要方(痛泻要方加珍珠母、素馨花、草豆蔻、草果、山药、甘草等组方而成)治疗肝郁脾虚型功能性腹泻的临床疗效。【方法】将60例肝郁脾虚型功能性腹泻患者随机分为试验组和对照组,每组各30例。对照组给予双歧杆菌三联活菌胶囊治疗,试验组给予珍素痛泻要方治疗,疗程为4周。观察2组患者治疗前后中医证候积分、生活质量健康调查简表(SF-36)评分、医院焦虑与抑郁量表(HAD)评分的变化情况,并评价2组患者的中医证候疗效和安全性。【结果】(1)治疗4周后,试验组的总有效率为83.33%(25/30),对照组为56.67%(17/30),组间比较,试验组的中医证候疗效明显优于对照组,差异有统计学意义(P<0.05)。(2)治疗后,2组患者SF-36量表的日常工作、精力、健康自评、情感职能、精神健康评分均较治疗前明显改善(P<0.01),且试验组在改善日常工作、精力、健康自评、情感职能、精神健康评分方面均明显优于对照组(P<0.05);而2组患者治疗前后的疼痛反应、社交活动、生理活动评分比较,差异均无统计学意义(P>0.05)。(3)治疗后,2组患者的中医证候积分和HAD评分均较治疗前明显改善(P<0.05或P<0.01),且试验组在改善中医证候积分和HAD评分方面均明显优于对照组(P<0.05或P<0.01)。(4)治疗过程中,2组患者均未出现明显的不良反应,且患者的生命体征、肝肾功能和血、尿、大便常规等安全性指标均无明显异常变化。【结论】对比双歧杆菌三联活菌胶囊,珍素痛泻要方治疗肝郁脾虚型功能性腹泻的临床疗效更加显著,能够更有效地改善患者腹泻症状,缓解焦虑抑郁状态,提高患者生活质量。

Objective To investigate the clinical efficacy of Zhen Su Tongxie Prescription(mainly composed of the ingredients of Important Formula for Relieving Diarrhea with Pain together with Concha Margaritifera,Flos Jasmini,Semen Alpiniae Katsumadai,Fructus Tsaoko,Rhizoma Dioscoreae,and Radix Glycyrrhizae)for the treatment of functional diarrhea(FD)with liver depression and spleen deficiency syndrome type.Methods Sixty FD patients with liver depression and spleen deficiency syndrome type were randomly divided into a trial group and a control group,with 30 cases in each group.The control group was treated with Enteric-coated Bifid Triple Viable Capsules and the trial group was treated with Zhen Su Tongxie Prescription.The course of treatment lasted for4 weeks.The changes in the scores of traditional Chinese medicine(TCM)syndrome,36-item short-form health survey(SF-36)scores and hospital anxiety and depression(HAD)scores in the two groups were observed before and after treatment.Meanwhile,the TCM syndrome efficacy and clinical safety in the two groups were also evaluated.Results(1)After 4 weeks of treatment,the total effective rate of the trial group was 83.33%(25/30)and that of the control group was 56.67%(17/30).The intergroup comparison showed that the TCM syndrome efficacy of the trial group was significantly superior to that of the control group,and the difference was statistically significant(P<0.05).(2)After treatment,the SF-36 scale scores of daily work,vitality,health selfassessment,emotional role functioning,and mental health in both groups were significantly improved compared with those before treatment(P<0.01),and the trial group was more effective on improving the scores of daily work,vitality,health self-assessment,emotional role functioning and mental health than the control group(P<0.05).However,while the differences in pain response,social role functioning,and physical role functioning of the two groups before and after treatment were not statistically significant(P>0.05).(3)After treatment,the TCM syndrome scores and HAD scores of both groups were significantly improved compared with those before treatment(P<0.05 or P<0.01),and the trial group was more effective on improving the TCM syndrome scores and HAD scores than the control group(P<0.05 or P<0.01).(4)During the treatment,no significant adverse reactions were found in the two groups,or no significant abnormal changes were found in the patients’vital signs,and safety indicators of liver and kidney function,and routine test of blood,urine,and stool.Conclusion Compared with Enteric-coated Bifid Triple Viable Capsules,the clinical efficacy of Zhen Su Tongxie Prescription exerts significant effect in treating FD of liver depression and spleen deficiency syndrome type,which is effective on improving diarrhea symptoms,relieving anxiety and depression,and improving patients’quality of life.