Objective The patients with diarrhea-type irritable bowel syndrome(Gan Pi Bu He)were treated with Guchang Zhixie Pill combined with Jinshuangqi to verify and evaluate the clinical efficacy and safety.Method Seventy patients who met the inclusion criteria of this study were selected and divided into experimental group and control group(35in each group)according to the random number table.Among them,2 cases fell off in the experimental group and 1 case in the control group.In the treatment,the experimental group was treated with Guchang Zhixie Pill combined with Jinshuangqi tablets,and the control group was treated with trimebutine maleate dispersible tablets combined with Jinshuangqi tablets;the two groups were observed before treatment,after 1 week of treatment and after 2weeks of treatment.TCM symptom assessment,IBS symptom severity score,quality of life assessment and psychological status assessment,post-treatment syndrome evaluation,recurrence and safety indicators.Results1.Comparison of total scores of TCM symptoms: After 1 week of treatment,the total scores of the two groups were lower than that of the group before treatment,and the total scores of the two groups were decreased after 1 week of treatment.The total score of the experimental group was lower than that of the control group.The total score was low and the drop was significant(P<0.05).2.Comparison of individual TCM symptom scores: After 1 week of treatment,the symptom scores of the two groups were lower than before treatment(P<0.05),and the symptom scores of the experimental group were lower than the control group(P<0.05);after 2 weeks of treatment The scores of abdominal pain,diarrhea,poor appetite and emotional depression or irritability were lower than those in the previous stage(P<0.05),and the experimental group decreased significantly(P<0.05).The experimental group suffered from fatigue and weakness.The boring score decreased significantly(P<0.05),while the control group had no significant effect(P>0.05).Both groups had lower abdominal distension and defecation discomfort scores than the previous one(P<0.05).Significant(P<0.05).3.Evaluation of syndrome efficacy: After 1 week of treatment,the total effective rate of the experimental group was 87.7% higher than the total effective rate of the control group(82.3%),P<0.05;after 2 weeks of treatment,the total effective rate of the experimental group was 96.9%.The total effective rate(97.0%)was similar to the control group,P>0.05.4.Comparison of IBS Symptom Severity Scale: After treatment,the total scores of the two groups were lower than those of the previous stage,and the reduction of the scores of the experimental group in the same stage after treatment was significantly better than that of the control group(P<0.05).5.IBS-QOL evaluation: After treatment,the total scores of the two groups increased compared with the previous stage,while the total score of the experimental group increased significantly after 2 weeks of treatment(P<0.05).6.Psychological state evaluation: After treatment,the HAMA score and HAMD score of the two groups were lower than those of the previous stage(P<0.05),and the experimental group was significantly lower(P<0.05).The anxiety and depression status of the experimental group after treatment.The decline was significantly greater than the control group.7.Recurrence rate: 4 weeks after drug withdrawal,the recurrence rate of 4 patients in the experimental group(12.1%)was lower than that of 6 patients in the control group(17.6%),P < 0.05.8.Safety assessment: There were no grade 4 adverse reactions in either group.Conclusion Guchang Zhixie Pill combined with Jinshuangqi has a good overall effect on hepatosplenic dysfunction type IBS-D treatment;in improving individual symptoms(abdominal pain,diarrhea,poor appetite,defecation and emotion)Depression or irritability,fatigue,and two flaccid sputum have obvious curative effect;can improve the quality of life of patients;also have a good effect on improving patients' depression and anxiety;and the medication is safe and reliable. |