Analysis of the interventional effects of ambroxol hydrochloride and ontelukast sodium combined with azithromycin on immune function and C-reactive protein serum expression in children with severe Mycoplasma pneumoniae pneumonia.
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OBJECTIVE: The aim of the study was to investigate the clinical effects of ambroxol hydrochloride and montelukast sodium combined with azithromycin on immune function, inflammatory cytokines, and pulmonary function in children with severe Mycoplasma pneumoniae pneumonia (SMPP). METHODS: A retrospective cohort study was conducted on 103 children with SMPP treated at Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science & Technology, from February 2023 to February 2025. On the basis of different treatment regimens recorded in the electronic medical record system, the children were divided into a control group (n = 50, montelukast sodium combined with azithromycin) and an observation group (n = 53, ambroxol hydrochloride added to the control regimen). To address the selection bias inherent in the retrospective design, a propensity score analysis based on inverse probability of treatment weighting (IPTW) was performed; a logistic regression model incorporating age, sex, disease duration, only-child status, paternal and maternal education levels, and place of residence as covariates was used to derive the propensity scores, and stabilized weights were applied so that all 103 patients contributed to the weighted analysis without exclusion. Clinical data were collected and compared, including baseline characteristics, symptoms and signs (time for cough to subside, time for body temperature to normalize, time for sputum to disappear, and time for rales to disappear), immune function (CD3+, CD4+, CD8+, CD4+/CD8+), inflammatory cytokines [tumor necrosis factor-alpha (TNF-α), interferon-gamma (IFN-γ), interleukin-2 (IL-2), interleukin-4 (IL-4), and C-reactive protein (CRP)], pulmonary function [forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and maximal mid-expiratory flow (MMEF)], clinical efficacy, and adverse reactions. The total clinical efficacy rate was pre-specified as the primary outcome, and all remaining endpoints were treated as secondary or exploratory; a Bonferroni-corrected significance threshold of α = 0.003 was applied across the 16 secondary continuous outcomes. Effect sizes (Cohen's d) and 95% confidence intervals (CIs) were computed for all between-group comparisons. RESULTS: After treatment, the observation group showed significantly greater improvement in symptoms and signs, immune function, inflammatory cytokines, and pulmonary function compared with the control group (all P < 0.05). The total clinical efficacy rate of the observation group was significantly higher than that of the control group [96.23% vs. 82.00%; χ 2 = 5.459, P = 0.019; odds ratio (OR) = 5.59, 95% CI: 1.14-27.38; the wide confidence interval, driven by the small number of ineffective cases, indicates that the magnitude of the efficacy advantage should be interpreted with caution]. The total incidence of adverse reactions was comparable between the observation group and the control group (11.32% vs. 10.00%; χ 2 = 0.047, P = 0.828), indicating acceptable safety. CONCLUSION: The triple combination of ambroxol hydrochloride, montelukast sodium, and azithromycin is associated with improved inflammatory status, enhanced immune function, and better pulmonary function in children with SMPP, with a favorable safety profile. These findings warrant confirmation in prospective, multicenter randomized controlled trials.