OBJECTIVE To investigate the effects of Xiao’er Zhike Pingchuan syrup on immune inflammation and gut microbiota in children with phlegm heat resistant pulmonary asthma based on the “lung gut axis” analysis.

METHODS Eighty children with acute asthma who came to our hospital for treatment from January 1, 2023 to June 30, 2024 were randomly divided into a traditional Chinese medicine treatment group(TCM group) of 40 cases and a placebo treatment group(placebo group) of 40 cases using a random number table method. The TCM group was treated with Xiao’er Zhike Pingchuan syrup, while the placebo group was treated with placebo syrup orally. Comparing the clinical efficacy of two groups, including asthma control test(ACT) questionnaire, lung functionmeasuring forced expiratory volume in first second(FEV1), forced vital capacity(FVC), peak expiratory flow(PEF), immune cell content(Th1, Th2, Treg, Th17, Th22), serum cytokines and mediators(IFN - γ, IL-4, IL-10, periostin, eotaxin, ADAM33). Analyzing the composition of gut microbiota in patient fecal samples using 16S rRNA gene sequencing technology, and analyzing changes in beneficial bacteria(such as Bifidobacterium and Lactobacillus) and potential harmful bacteria(such as Bacteroides and Clostridium). Pearson analysis was used to investigate the correlation between immune inflammatory markers and gut microbiota structure.

RESULTS The total effective rate in the TCM group (90.00%) was significantly higher than that in the placebo group(P<0.01). After treatment, the ACT scores, FEV1, FEV1/FVC, Th1, Treg, IFN-γ, and the abundances of beneficial bacteria(Bifidobacterium and Lactobacillus) were significantly increased in both groups; specifically, the ACT scores, FEV1, FEV1/FVC, Treg, and IFN-γ in the TCM group were significantly higher than those in the placebo group(P<0.001), and Th1 and the abundances of beneficial bacteria were also significantly higher than those in the placebo group(P<0.05). The PEF difference rate, Th2, Th17, Th22, IL-4, IL-10, periostin, eotaxin, ADAM33, and the abundances of potential harmful bacteria(Bacteroides and Clostridium) were significantly decreased in both groups; specifically, the PEF difference rate, Th17, Th22, IL-4, IL-10, periostin, eotaxin, and ADAM33 in the TCM group were significantly lower than those in the placebo group(P<0.001), and Th2 and the abundances of potential harmful bacteria were also significantly lower than those in the placebo group(P<0.05). Pearson analysis showed that IFN-γ was positively correlated with Bifidobacterium and Lactobacillus, and negatively correlated with Bacteroides and Clostridium(P<0.05). IL-4, IL-10, periostin, eotaxin, and ADAM33 were positively correlated with Bacteroides and Clostridium, and negatively correlated with Bifidobacterium and Lactobacillus(P<0.001).

CONCLUSION The clinical effect of Xiao’er Zhike Pingchuan syrup in treating children with phlegm heat resistance pulmonary asthma is significant. It may improve clinical symptoms by regulating immune inflammatory response and gut microbiota, providing new ideas for the treatment of asthma.