Abstract
BACKGROUND: Mycoplasma pneumoniae pneumonia (MPP) is a common respiratory infection in children, current treatments are limited by resistance and side effects. This study aims to evaluate the clinical efficacy and safety of combining Qingke Mixture with azithromycin for treating MPP in children. METHODS: This prospective, randomized, double-blind, controlled trial included 92 children diagnosed with MPP. The treatment group received Qingke Mixture and azithromycin, while the control group received azithromycin alone. Outcomes assessed included clinical symptoms, inflammatory markers, immune response, pulmonary function, and adverse events. RESULTS: The treatment group showed significantly higher clinical efficacy (95.65% vs 80.43%, P < 0.05). The treatment group showed faster resolution of pulmonary symptoms, shorter hospital stays, and greater improvements in pulmonary function and TCM symptom scores (P < 0.05). Inflammatory markers (WBC, CRP, IL-6, IL-8) were significantly lower, while immunoglobulin levels (IgA, IgG, IgM) and T lymphocyte subsets (CD3+, CD4+/CD8+ ratio) were higher in the treatment group compared to the control group (P < 0.05). The incidence of adverse events was low in both groups, with no statistically significant difference. CONCLUSION: Qingke Mixture combined with azithromycin significantly improves clinical outcomes in children with MPP, enhancing efficacy while maintaining safety.