| Objective: In this study,the clinical effect of Wenwei Jianpi Yishen Decoction in the treatment of diarrhea predominant irritable bowel syndrome(IBS-D)with spleen kidney yang deficiency was observed by comparing with oral trimebutine maleate tablets.The objective of the study is to evaluate the efficacy and safety of Wenwei Jianpi Yishen Decoction in the treatment of this disease,explore its pathogenesis,and provide scientific basis for its further research and clinical application.Methods: In this study,60 patients with IBS-D(spleen kidney yang deficiency type)in the Department of spleen and stomach of Baoding First Hospital of traditional Chinese medicine from September 2019 to October 2020 were randomly divided into two groups.The experimental group was treated with Wenwei Jianpi Yishen Decoction,and the control group was treated with trimebutine maleate tablets.After 14 days of treatment,the efficacy of Wenwei Jianpi Yishen Decoction was evaluated according to the difference of TCM syndrome efficacy,total TCM syndrome score,IBS-SSS,single symptom score,safety and recurrence rate after stopping taking medicine.Results:(1)The results of comparison of the efficacy of TCM syndromes before and after treatment: After evaluation and comparison,there is a statistical difference(P<0.05),the total effective rate of the test group is 96.67%,and the total effective rate of the control group is 63.33%.It shows that the TCM clinical treatment effect of Wenwei Jianpi Yishen Decoction is significant.(2)Comparison results of the total scores of TCM syndromes before and after treatment: The comparison before treatment showed no statistical difference(P>0.05);after treatment,there was a difference,which was statistically significant(P<0.05).The score of the test group was significantly lower than that of the control group.Wenwei Jianpi Yishen Decoction has a significant effect in reducing this score and can significantly improve clinical symptoms.(3)Comparison results of IBS-SSS scores before and after treatment: Calculated and compared between the two groups,there is no statistical difference before treatment(P>0.05)and can be compared;there is a difference after treatment,with statistical significance(P<0.05),the test group score Lower than the control group.It shows that Wenwei Jianpi Yishen Decoction is effective in improving the severity of the overall symptoms.(4)Comparison of curative effect of main symptoms:After treatment abdominal cold pain,abdominal distension,chilly limbs,diarrhea in the morning,pain reduction after diarrhea,mental fatigue,weakness of waist and knee,and numbness(P<0.05).The therapeutic effect of Wenwei Jianpi Yishen Decoction was better than that of the control group.(5)The recurrence rate of the two groups was significantly different(P<0.05).The recurrence rate was 16.00% in the experimental group and 53.33% in the control group.It shows that the recurrence rate of Wenwei Jianpi Yishen Decoction is better than that of the control group.(6)Safety comparison: The physical condition,routine examination of blood,urine and stool,and ECG of the two groups had no obvious abnormal changes.After statistical observation,the liver and kidney function indexes(AST,alt,DBIL,ibil,CRE,BUN)of the two groups were not significantly abnormal.Conclusion: Wenwei Jianpi Yishen Decoction,based on the idea of "strengthening the spleen first warming the stomach",is simple in medication and reasonable in compatibility.It can simultaneously solve the functional damage of stomach,spleen and kidney from the perspective of traditional Chinese medicine,and treat the clinical symptoms of IBS-D(spleen kidney yang deficiency type)from the overall point of view.Wenwei Jianpi Yishen Decoction has a significant therapeutic effect on each observation item,and there is no obvious adverse reaction,and it has a clear clinical advantage over the temporary relief treatment of Western medicine in a certain period of time. |