黄厚止泻滴丸治疗腹泻型肠易激综合征临床研究OA

Objective To observe the effectiveness and mechanism of Huanghou Zhixie Dripping Pills(HZDP)in treating diarrhea-predominant irritable bowel syndrome(IBS-D).Methods A randomized controlled trial design was adopted to include 72 patients with IBS-D.Patients were randomly assigned to the treatment group(given HZDP for oral use)and the control group[given Combined Bifidobacterium,Lactobacillus,Enterococcus and Bacillus cereus Tablets,(live)for oral use],with 36 cases in each group.Additionally,20 healthy volunteers were enrolled as the healthy control group.Evaluation indicators included clinical efficacy,intestinal flora structure(assessed via 16S rRNA sequencing),bile acid profiles(analyzed by targeted metabolomics),serum inflammatory factors and markers of intestinal barrier function(measured by ELISA).Results After 4 weeks of treatment,the total effective rate of the treatment group(97.2％)was significantly higher than that of the control group(45.7％,x2=20.79,P＜0.01).Moreover,it also showed superior improvements in the Numerical Rating Scale(NRS)for abdominal pain,Bristol Stool Form Scale,and IBS Symptom Severity Scale(IBS-SSS)compared to the control group(P＜0.05).The analysis showed that HZDP could regulate the intestinal flora structure,manifested as increased in abundance of Bacteroidota and Prevotella_9,and decreased abundance of Firmicutes and pro-inflammatory genera(e.g.,Escherichia_Shigella),Additionally,it markedly reduced the concentration of 3-dehydrocholic acid(3-DHCA),a secondary bile acid,and significantly lowered the levels of serum pro-inflammatory factors(TNF-α,IL-6),5-hydroxytryptamine(5-HT),and markers of intestinal barrier damage(Zonulin and Calprotectin)(P＜0.01).Conclusions The total effective rate and symptom improvement effect of HZDP were both superior to those of Combined Bifidobacterium,Lactobacillus,Enterococcus and Bacillus cereus Tablets(live).Its therapeutic effect may be related to the coordinated regulation of the intestinal flora-bile acid metabolism-immune barrier network.