| Purpose:to evaluate the efficacy and safety of Chinese medicine prescribed by treating determination based on the spleen on treating functional diarrhea and the change of VIPã€SS and NPY in serum and from the brain-gut axis way to explore the mechanism of Chinese medicine prescribed by treating determination based on the spleen against functional diarrhea.Material and method:60 cases of functional diarrhea patients were hierarchically,groupingly and randomly divided into the observation group with 35 cases and the control group with 25 cases.The participants in the control group were given placebo and those in the observation group were given Chinese medicine prescribed by treating determination based on the spleen.The ones with insufficiency of the spleen-Qi and obstruction of damp were given the â…£ spleen-deficiency formulas and the others with insufficiency of the spleen-Yang were given the â…¤ spleen-deficiency formulas,3 times a day and 1 bag each time.The period of treatment was for 4 weeks respectively.The samples of the blood and the urine were collected before and after the treatment,and detected collectively.The D-xylose discharge rate of urine and the content of D-xylose in serum were detected by phloroglucinol method,the expression of VIP,SS,NPY in serum were measured respectively by Elisa.After the treatment,the efficacy was evaluated according to the stool frequency,the syndrome scores,the hospital anxiety and depression(HAD) scale,the excretion of D-xylose in urine,the content of D-xylose in serum, the change of VIPã€SSã€NPY in serum and observed the adverse event.Results:1. 67 cases were participated in this clinical trial who were patients in theclinc or the ward of the hospital of Liaoning University of Traditional Chinese Medicine from January to May in the year 2014. 60 cases diagnosed with functional diarrhea patients were randomly divided into the observation group with 35 cases and the control group with 25 cases.The baseline of both groups was no statistically significant(P>0.05). 2.After four weeks of medication,there were 6 patients dropped off who were in the observation group and at the end,the observation group with 29 cases and the control group with 25 cases.By taking the intention-to-treat method,the total effective rate of the observation group was 65.71% and the control group was 16.0%,the difference of both groups was statistically significant(P<0.01). 3.The stool frequency in both groups were decreased,and the changes in the observation group was respectively higher than that in the control group(P<0.01). 4.Compared before and after treatment, the total syndrome scores in both groups were decreased,and the changes in the observation group was respectively higher than that in the control group(P<0.01). 5.Before the treatment,the difference of the hospital anxiety and depression(HAD)scores in both groups was not statistically significant(P>0.05);Compared before and after treatment,the hospital anxiety and depression(HAD)scores in both groups were decreased,and the changes in the observation group was respectively higher than that in the control group(P<0.01). 6.Compared before and after treatment,The observation group in the excretion of D-xylose in urine and the content of D-xylose in serum were higher than before(P<0.01),the difference of the control group was not statistically significant(P>0.05),and the changes in the observation group was respectively higher than that in the control group(P<0.01). 7.The D-xylose discharge rate of urine in the ones with insufficiency of the spleen-Qi and obstruction of damp was higher than that in the others with insufficiency of the spleen-Yang(P<0.01).8.After treatment,the level of NPY in serum in both groups were increased,the level of VIP and SS in serum in both groups were decreased,the changes of the level of VIP and NPY in the observation group was respectively higher than that in the control group(P<0.05). 9.The relation between the content of D-xylose in serum and the excretion of D-xylose in urine was positive correlation(Spearman r=0.961,P<0.01). 10.The relation between the content of NPY and the hospital anxiety and depression(HAD)scores was negative correlation(Spearman r=-0.653,P<0.01). 11.The difference of the level of VIPã€SS and NPY in serum between the ones with insufficiency of the spleen-Qi and obstruction of damp and the others with insufficiency of the spleen-Yang was not statistically significant(P>0.05). 12.In terns of gender,the difference of the level of VIPã€SS and NPY in serum between men and women was not statistically significant(P>0.05). 13.During the trial,no adverse event appeared in this two groups.Conclusion:1.Chinese medicine prescribed by treating determination based on the spleen has reliable and safe effect on functional diarrhea. 2. Chinese medicine prescribed by treating determination based on the spleen can promote the content of D-xylose in serum and the excretion of D-xylose in urine and improve the clinical symptoms of functional diarrhea. 3. The mechanism may has close effect on the promotion of the expression of NPY,the inhibition of the expression of VIP and SS, regulating the expression of the abnormal brain-gut peptide may be the key to the therapeutic effects of Chinese medicine prescribed by treating determination based on the spleen against functional diarrhea. |
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