| Objective:1.To evaluate the clinical efficacy and safety of Yizi Tang in patients with heat syndrome of constipation using a randomized controlled study method;2.To observe the effect of Yizi Tang on gut microbiota of patients with heat syndrome of constipation to speculate the possible mechanism of its action in the treatment of functional constipation.Methods:A random number table was generated by using EXCEL,and 60 patients with hot constipation who met the inclusion criteria were divided into 30 patients in the observation group and 30 patients in the control group according to the order of consultation,and the observation group was given oral Yizi Tang while the control group was given oral polyethylene glycol 4000 dispersedly.Data analysis were completetel using statistical software spss22.0(results are expressed as mean ± SDs).Results:1.Before treatment,there was no statistically significant difference in the general condition,constipation severity score(CSS)condition,heat syndrome of constipation quantification scale condition,and intestinal flora count between the two groups(P>0.05).2.After treatment,there were statistically significant differences in the changes of constipation severity score(CSS),quantification of heat syndrome of constipation symptoms and intestinal flora between the two groups compared with those before treatment(P<0.05).3.Statistical results of constipation severity score(CSS):In terms of overall score and frequency of defecation and other 8 groups of clinical symptoms,both the observation group and the control group were significantly improved compared with the pre-treatment period.There was a statistical difference between the two groups only in the improvement of the overall score and the nature of stool(P<0.05).There was no statistically significant difference between the two groups in the improvement of 7 groups of clinical symptoms,including frequency of defecation(P>0.05).4.Statistical results of the quantitative points of the heat-secret symptoms:there was a statistical difference between the two groups in terms of the overall points and the two clinical symptoms of dry mouth and red face(P<0.05).No statistically significant differences were found between the two groups for the 2 symptoms of bad breath and short red urine(P>0.05).The observation group showed statistically significant differences in overall score and four clinical symptoms such as dry mouth after treatment compared to before treatment(P<0.05),while the control group did not show statistically significant differences(P>0.05).The observation group showed statistically significant differences in overall score and four clinical symptoms such as dry mouth after treatment compared to before treatment(P<0.05),while the control group did not show statistically significant differences(P>0.05).5.Statistical results on the number of intestinal flora:the numberof bifidobacteria and other 5 types of flora in both groups were statistically different after treatment than before treatment(P<0.05).Statistically significant differences(P<0.05)were observed between the two groups in terms of the number of 2 types of flora affecting Bifidobacterium and Enterococcus,while no statistically significant differences(P>0.05)were seen between the two groups in terms of the number of 3 types of flora affecting Lactobacillus,Escherichia coli and Bacteroidetes.Conclusion:1.Yizi Tang has good clinical efficacy in the treatment of heat syndrome of constipation,and no serious adverse effect.2.In improving clinical symptoms(nature of stool,dry mouth,bad breath,red face and short red urine)in patients with heat constipation type constipation,YiziTang is superior to polyethylene glycol 4000 powder.3.Interms of improving intestinal flora,Yizi Tang was better than Polyethylene glycol 4000,and it is assumed that the mechanism of action of Yizi Tang in treating functional constipation may be related to the regulation of intestinal flora(especially bifidobacteria and enterococci). |
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