Study Of Curative Effect On Diarrhea-predominant Irritable Bowel Syndrome And Effect Of Intestinal Flora Treated By Shenling Baizhu Powder

OBJECT:1 Doing clinical observation proved the effectiveness of the spleen-strengthing herd and offered a reliable treatment and basis to IBS-D.2 Using 16SrRNA technology compared the differences of changes in the structure of intestinal microflora in IBS-D patients,before taking spleen-strengthing medicine,taking 4 weeks and 8 weeks.That provided basis relative revelance of intestinal microflora and traditional Chinese medicine.Methods:1 According to inclusion criteria and ruling out standard,we included IBS-D patients.Let them take spleen-strengthing medicine one bag every time,tid for 8 weeks.2 We included IBS-D patients according to inclusion criteria and ruling out standard and we took fecal specimens according to Standard Operating Procedure.Compare the a-diversity,?-diversity,differences of intestinal microflora structure before taking spleen-strengthing medicine,taking 4 weeks and 8 weeks with 16SrRNA technology.Results:1 We included 32 patients.Among them,there were 13 women and 19 men.The youngest was 24 years old and the oldest was 70 years old.before taking sple en-strengthing medicine,taking 4 weeks and 8 weeks.The results were as follow s:(1)Primary outcomesIrritable bowel syndrome severity score(IBS-SSS)average score of the IBS-D patients before taking medicine,after taking medicine 4 weeks and 8 weeks were 213.11±79.01?164.00±76.40?141.57±80.11.The differences were statistically significant with before taking medicine,taking medicine 4 weeks or 8 weeks.The differences of the degrees and frequency of abdominal pain dimensions were statistically significant with before taking medicine,taking medicine 4 weeks and 8 weeks.The differences of the degrees of abdominal distention and defecatory satisfaction dimensions were statistically significant with before taking medicine,taking medicine 4 weeks and 8 weeks.Impact of life distention was statistically significant between before taking medicine and after 8 weeks,but not statistically significant between before taking medicine and after 4 weeks.(2)Secondary outcomesSecondary outcomes included the ranked improvement of IBS-SSS,alteration in irritable bowel syndrome-quality of life questionnaire(IBS-QOL)total score and subscale score,patient reported outcome(PRO)total score and subscale score,TCM symptoms score.1)Ranked improvement of IBS-SSSAccording to the ranked improvement of IBS-SSS standard,recovery rate was 24.24%and effective rate was 69.67%.2)IBS-QOL total score and subscale scoreIrritable bowel syndrome-quality of life questionnaire(IBS-QOL)total score was statistically significant between before taking medicine and after 8 weeks,but not statistically significant between before taking medicine and after 4 weeks.Dysthymia,behavior disorder and health concern distension were statistically significant between before taking medicine and after 8 weeks,but not statistically significant between before taking medicine and after 4 weeks.Self image,social accommodation,sexual behavior,relationship development and food avoidance were not statistically significant between before taking medicine and after 4 weeks.3)PRO total score and subscale scorePatient reported outcome(PRO)total score was statistically significant between before taking medicine and after 8 weeks,but not statistically significant between before taking medicine and after 4 weeks.Differences of physical status and defecation were statistically significant with before taking medicine,taking medicine 4 weeks or 8 weeks.Differences of reflux degree,defecation,psychological health dimension were statistically significant with before taking medicine,taking medicine 4 weeks or 8 weeks.Differences of dyspepsia degree and social accomodation dimension were not statistically significant before or after taking medicine.(3)Assessment of safetyThere were no specific adverse events and laboratory test concerned research drug happened.2 There were 33 patients recruited.Among them there were 17 men and 16 wo men.There were no distinct differences with intestinal bowel microflora a-divers ity and P-diversity taking medicine before,after 4 weeks and 8 weeks.In Firmic utes,Mitsuokella and Defluviitaleaceae increased and Bacillus decreased.In Pr-oteobacteria,Alcaligenaceae and Neisseriaceae increased and Succinivibrio decre ased.In Bacteroidetes,an unclassified bacteria increased and Rhodothermaceae d ecreased.Fusobacterium increased in Fusobacteria.Bryobacter increased in Acid obacteria.