Objective : To observe the changes of clinical symptoms,TCM syndromes,the long-term efficacy and stool(Bristol stool method)after the patients with functional constipation(Qi stagnation and intestinal dryness type)were treated with Tongyou Granule.At the same time,to evaluate its safety,to provide a new idea for clinical treatment of functional constipation,and to provide practical experience for the development of new drugs for the treatment of constipation.Methods : The 76 patients were numbered.Number based on the order of treatment.Then 76 patients were divided into two groups.The two groups were treatment group and control group.On the basis of general treatment,treatment group was treated with Tongyou granule treatment,the control group was given the treatment of Qirong Runchang oral liquid.The two groups were treated with a course of 1 months,observed the course of treatment for 1 months,and the patients were followed up for a period of 3 months after the end of the course of treatment in the two groups.Before and after treatment,two groups of patients with comprehensive efficacy,TCM syndrome efficacy,the improvement of symptoms,long-term efficacy and adverse events were evaluated,while at the same time to observe the recurrence rate of patients.Results :(1)Comprehensive curative effect: according to the comprehensive curative effect evaluation standard,the treatment group had 4 cases cured,30 cases improved,and the other 4 cases were invalid.The total effective rate was 89.5%.In the control group,1 cases were cured,27 cases were improved,and the other 10 cases were invalid.The total effective rate was73.7%.Rank sum test was used to analyze the results,Z=-2.102,P=0.036<0.05,with statistical difference.The curative effect of the two groups were compared,the treatment group was better than the control group(2)Chinese medicine syndrome efficacy: In the treatment group,5 cases were cured,and the curative effect of the treatment was significant in 20 cases,10 cases were effective,and 3 cases were invalid.The total effective rate was 92.1%.In the control group,2 cases were cured,10 cases were markedly improved,19 cases were effective,and 7 cases were invalid.The total effective rate was 81.6%.The results were analyzed by rank sum test,Z=-2.863,P=0.004<0.05,there were statistically significant differences.In the treatment of TCM syndrome,the treatment group was better than the control group.(3)Recurrence rate: after 3 months of treatment,the patients in the two groups were followed up.According to the criteria of disease recurrence,the recurrence rate of the treatment group was significantly lower than that of the control group.Statistical analysis was used to deal with the results,P=0.039<0.05.There was statistical difference.The treatment group was better than the control group in the control of disease recurrence rate.(4)Safety evaluation: Safety indicators before and after treatment of the 76 patients enrolled,including blood routine,urine routine,stool routine,fecal occult blood test,liver function,renal function,electrocardiogram,were in the normal range.Conclusion : The curative effect of Tongyou granule in the treatment of functional constipation(Qi stagnation and intestinal dryness type)is obvious.Tongyou granule can effectively improve the symptoms of patients,improve the quality of life of patients,reduce the recurrence of the disease.It has low cost and high safety,which is worthy of clinical application. |