| Objective: To evaluate the clinical efficacy and safety of Shugan Jieyu capsule combined with trimebutine maleate tablets in the treatment of diarrhea-predominant irritable bowel syndrome complicated with depressive state.Method: Patients with irritable bowel syndrome who met the criteria were randomly divided into two groups.the experimental group was given Shugan Jieyu capsule and trimebutine maleate tablets orally,while the control group was given Shugan Jieyu capsule simulator and trimebutine maleate tablets orally.The course of treatment was 8 weeks.after 4 weeks of withdrawal,the changes of IBS symptom severity scale(IBS-SSS),Hamilton-17 depression scale and quality of life score(IBS-QOL)were observed before and after treatment,and the occurrence of adverse reactions was recorded.Results:1.A total of 60 cases were completed,29 cases in the experimental group and 31 cases in the control group.IBS symptom severity scale: the scores of the two groups after treatment were lower than those before treatment,and there was significant difference between the two groups before and after treatment(P < 0.01),The effect after treatment is better than before treatment.There was significant difference between the two groups at 4weeks and 8 weeks after treatment(P < 0.05),The experimental group was better than the control group.The cure rate was 13.79%,the total effective rate was 86.21%,and the recurrence rate was 20% in the experimental group.In the control group,the cure rate was9.68%,the total effective rate was 74.13%,and the recurrence rate was 34.78%.There was significant difference in the total effective rate and recurrence rate between the two groups(P < 0.05),The experimental group was better than the control group.2.Hamilton-17 depression scale: the scores of the two groups after treatment were lower than those before treatment,and there was significant difference between the two groups before and after treatment(P < 0.01),The effect after treatment is better than before treatment.There was significant difference between the two groups at 4 weeks and 8 weeks after treatment(P < 0.01),The experimental group was better than the control group.Follow-up after medication,there was significant difference between the two groups(P <0.01).Adding with Shugan Jieyu capsule,long-term effect is better.3.The score of quality of life in the two groups after treatment was lower than that before treatment,and there was significant difference between the two groups before and after treatment(P < 0.01),The effect after treatment is better than before treatment.At 4 and 8weeks after treatment,there was significant difference between the two groups(P <0.01),The experimental group was better than the control group.Follow-up after medication,there was significant difference between the two groups(P < 0.01).Adding with Shugan Jieyu capsule,long-term effect is better.4.There were no adverse events in both groups during the trial.Conclusion:1.Shugan Jieyu capsule combined with trimebutine maleate tablets can effectively improve the severity of abdominal pain,depressive state,quality of life and reduce the recurrence rate.it is suggested that the drug should be used for at least 4 weeks.2.Shugan Jieyu capsule is safe in clinical use,and it is suggested that it should be popularized and used in clinic. |