| Objective:To observe the clinical efficacy and safety of Shenling Baizhu powder in the treatment of functional diarrhea(FDR)with spleen deficiency syndrome through clinical trials,and to explore the possible influence of the formula on the serum 5-HT concentration and fecal short chain fatty acids in FDR patients with spleen deficiency syndrome,hoping to provide new clues for the study of the therapeutic mechanism of Shenling Baizhu powder in the treatment of FDR.Method:From December 2018 to January 2020,60 patients with functional diarrhea diagnosed by western medicine and sPleen deficiency syndrome identified by traditional Chinese medicine were collected from the outpatient department of sPleen and stomach disease department of Xiyuan Hospital,Chinese Academy of traditional Chinese medicine.The patients were randomly divided into experimental group and control group with 30 cases in each group.The experimental group was given Chinese compound Shenling Baizhu granules The control group was treated with placebo,and the course of treatment is one month.The main efficacy indexes were Bristol Stool Scale,clinical global impressions scale,and the secondary efficacy indexes were TCM syndrome integral scale and the MOS item short from health survey.Serum and feces were collected before and after treatment.The level of 5-HT in serum of Patients was detected by enzyme-linked immunosorbent assay(ELISA),while the quantitative analysis of short chain fatty acids in feces was detected by lc-ms4 liquid chromatograPhy-mass spectrometry(lc-ms4).Then,the changes,interrelations and the role of Shenling Baizhu Powder were discussed.Result:1.Comparison of Bristol fecal character scale:there were significant differences in Bristol fecal character between the experimental group and before treatment(P<0.01)at 2 weeks,4 weeks and 4 weeks after drug withdrawal;there were also significant differences between the control group and before treatment at 2 weeks,4 weeks and 4 weeks after drug withdrawal(P<0.01).There was no significant difference between the experimental group and the control group before treatment(P>0.05),and there was no significant difference between the two group s after two weeks of treatment(P>0.05),but there was significant difference between the two groups after four weeks of treatment and four weeks of discontinuation(P<0.05).2.ComParison of clinical general impression scale:in the experimental group,there were 6 cases with obvious remission of symptoms of functional diarrhea,accounting for 24%of the total,16 cases with mild remission,accounting for 64%,3 cases without remission,accounting for 12%;after 4 weeks of treatment,there were 2 cases with complete remission,accounting for 8%of the total,8 cases with obvious remission,accounting for 32%,13 cases with mild remission,accounting for 52%,and 2 cases without remission,accounting for 8%.The scores of the two groups were statistically significant after 2 weeks of treatment(z=-2.154,P=0.031<0.05),and there was a significant difference after 4 weeks of treatment(z=-2.885,P=0.004<0.01).3.Comparison of TCM syndrome score:after 4 weeks of treatment,the total effective rate of the experimental group was 68%,and that of the control group was 28%.There was significant difference between the two groups(z=8.215,P=0.029<0.05).There was significant difference in TCM syndrome score between the experimental group and the pre-treatment group after 2 and 4 weeks of treatment(P<0.05);there was no significant difference between the control group and the Pre-treatment grouP after 2 and 4 weeks of treatment(P>0.05).There was no significant difference(P>0.05).between the experimental group and the control group before and after treatment for 2 weeks,and there was significant difference(P<0.05)between the four weeks and before treatment.In the experimental group,after 4 weeks of treatment,there were significant differences between the three items of asthenia of limbs,fear of cold and loose stools(P<0.05).4.SF-36 scale comparison:after 4 weeks of treatment,GH score of the experimental group was significantly different from that before treatment(P<0.05);there was no significant difference in other dimensions(P>0.05).There was no significant difference between the two groups before and after treatment(P>0.05).After 4 weeks of treatment,there were significant differences in VT and GH dimensions between the experimental group and the control group(P<0.05),but no significant differences in other dimensions(P>0.05).5.To compare the changes of faecal short chain fatty acids in FDR patients.After 4 weeks of treatment,the content of isovaleric acid in the experimental group was significantly different from that before treatment(P<0.05);there was no significant difference between butyric acid and acetic acid before and after treatment;the content of propionic acid,isobutyric acid,valeric acid,hexanoic acid and heptanoic acid decreased after treatment,but there was no significant difference.There was no significant difference in the content of short chain fatty acids in the control group before and after treatment(P>0.05).6.The change of serum 5-HT in FDR Patients:there was no significant difference between the experimental group and the control group before and after treatment(P>0.05);there was no significant difference between the two groups(P>0.05).There was a positive correlation between serum 5-HT and fecal valeric acid(r=0.492,P=0.017).7.During the follow-up period,the two groups of subjects did not have obvious adverse reactions related to the test drug.The safety inspection before and after treatment showed that there were no obvious abnormalities in the blood routine,liver and kidney function,fasting blood glucose,urine stool routine+occult blood test and ECG results,which had better safety.Conclusion:1.Shenling Baizhu Powder has a good effect on improving stool characteristics and diarrhea frequency of FDR patients,and its clinical effect is relatively stable and safety is high.After treatment,FDR symptoms of the patients developed in a better direction,the patients scores of general health perception increased significantly,and the improvement of energy was significantly different from that of the control group.2.In the treatment of FDR patients with Shenling Baizhu Powder,the symptoms of asthenia of limbs,fear of cold and loose stools,which belong to spleen dysfunction and cold dampness resistance,were significantly improved.3.Shenling Baizhu Powder treatment of FDR spleen deficiency syndrome,the total short chain fatty acid content in the feces of patients decreased;the content of isovaleric acid decreased significantly;the content of valeric acid,isobutyric acid,hexanoic acid,heptanoic acid decreased,but there was no significant effect on the serum 5-HT content of patients.There was a weak positive correlation between the content of valeric acid and the content of 5-HT.Shenling Baizhu Powder may regulate the short chain fatty acid synthesis of intestinal flora to achieve the therapeutic effect on FDR patients with spleen deficiency syndrome.Shenling Baizhu Powder may regulate the short chain fatty acid synthesis of intestinal flora to achieve the therapeutic effect on FDR Patients with spleen deficiency syndrome. |
PDF Full Text Request