| ObjectiveTo evaluate the clinical efficacy and safety of GegenQinlian Pill in the treatment of children with NoV acute gastroenteritis and provide scientific basis for the treatment of NoV acute gastroenteritis with traditional Chinese medicine.Through the histological study and functional analysis of gut microbiota in children with NoV acute gastroenteritis,as well as the change of gut microbiota and the influence of related immune function after GegenQinlian Pill treatment of children with NoV acute gastroenteritis,new targets are provided for the study of pathogenic mechanism of NoV based on gut microbiota and the mechanism of action of anti-NoV drugs.MethodsIn this study,60 children with NoV acute gastroenteritis admitted to the hospital were randomly divided into GegenQinlian Pill group(GQP group)and treatment control group(TC group),with 30 cases in each group.The TC group was treated with oral montmorillonite powder,and the GQP group was treated with oral GegenQinlian Pill.The course of treatment was 3 days,with a follow-up of 7 days.The observation indicators of clinical efficacy mainly include the improvement of clinical symptoms(time to relieve fever,time to stop vomiting,time to stop diarrhea),the total effective rate of treatment and the level of viral load.Meanwhile,compare the changes in serum inflammatory cytokine levels(IL-2,IL-10,IFN-γ)between the two groups,in order to preliminarily explore their potential regulatory effects on immune function in children with NoV acute gastroenteritis.After the treatment,5 patients in the treatment control group(TC group)and 5 patients in the GegenQinlian Pill group(GQP group)were randomly selected,5 patients who had not been treated on the first day of diagnosis of NoV acute gastroenteritis were selected as the norovirus group(NV group),and 5 healthy children were selected as the healthy control group(HC group).Fecal samples were collected for the analysis of metagenomic of gut microbiota,and the species and functional distribution and changes of gut microbiota in each group were compared.ResultsAfter treatment with GegenQinlian Pill,the time to stop diarrhea in GQP group was 4.00(3.00-4.25)days,which was significantly shorter than that in TC group.The time to relieve fever in GQP group was 2.00(2.00-3.00)days,which was significantly shorter than that in TC group.And the difference was statistically significant(P<0.001).However,there was no significant difference between the two groups in the time to stop vomiting(P=0.307,P>0.05).The total effective rate of GQP group was 86.67%,significantly higher than that of TC group(56.67%).The difference between the two groups was statistically significant(P=0.002,P<0.01).The viral load measurement showed that the virus copies in both groups decreased significantly after treatment compared to before treatment,and the GQP group was significantly lower than the TC group after treatment(P<0.01).On the level of serum cytokines,The levels of IL-2 and IFN-γ after treatment in both groups were significantly lower than those before treatment in the same group(P<0.001).In the level of IL-10,there was no significant difference in the same group before and after treatment(P>0.05),and the difference between the two groups was not statistically significant(P>0.05).The results of macrogenome sequencing analysis of gut microbiota showed that the relative abundance of Firmicutes in GQP group was significantly lower than that in HC group in terms of species analysis;The abundance of Euryarchaeota in GQP group was significantly lower than that in NV group and TC group,but there was no significant difference between GQP group and HC group.At the level of genus,the distribution differences of the top 10 major bacteria with relative abundance were not statistically significant.At the bacterial level,the relative abundance of Faecalibacterium prausnitzii in GQP group was significantly lower than that in HC group(P<0.05).Through the difference discrimination analysis among multiple groups,it was found that the abundance of Clostridia,Eubacteriales,Lachnospiraceae,Eubacteriaceae,Roseburia,Eubacterium,Blautia,Coprococcus and unknown bacteria belonging to Lachnospiraceae in HC group was significantly higher than the other three groups.In NV group,the abundance of Ruminococcus was significantly higher than that of the other three groups.The abundance of Dorea belonging to Lachnospiraceae in TC group was significantly higher than that in other three groups(above LDA score>3,P<0.05).In terms of functional analysis of gut microbiota,no significant difference was found between groups based on Level 1.Based on the analysis of Level 2,it was found that the abundance of four seed functions in HC group was significantly higher than that in other three groups.The abundance of carbohydrate metabolism and metabolism of other amino acids in GQP group was significantly higher than that in other three groups(LDA score>3,P<0.05).Based on Level 3,there were also significant differences in some metabolic pathways between the groups(LDA Score>2,P<0.05).ConclusionThrough clinical research,gut microbiota metagenomics,and LEFSe analysis,it is suggested that GegenQinlian Pill can promote upregulation of glucose metabolism and amino acid metabolism(degradation),downregulate the abundance of Firmicutes and Euryarchaeota,reduce the stimulation effect of NoV on intestinal epithelial cell infection in children,and lead to the level of IL-2 and IFN-γ decreases,thereby decreasing the viral load and improving clinical symptoms such as diarrhea and fever in NoV acute gastroenteritis.The research results provide a preliminary theoretical basis for further exploring the anti NoV mechanism of GegenQinlian Pill based on gut microbiota metabolism function. |
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