Efficacy of azithromycin sequential therapy combined with montelukast in the treatment of pediatric mycoplasma pneumonia: A meta-analysis.

backgroundMycoplasma pneumoniae pneumonia (MPP) stands as a predominant cause of community-acquired respiratory infections in children. With the increasing prevalence of macrolide-resistant Mycoplasma pneumoniae strains, the therapeutic efficacy of azithromycin monotherapy has become a growing concern in clinical practice. Montelukast sodium, a selective leukotriene receptor antagonist, has emerged as a promising adjunctive agent, as it can effectively alleviate airway inflammation and reduce airway hyperresponsiveness. This meta-analysis was designed to systematically evaluate the efficacy and safety of azithromycin sequential therapy combined with montelukast in the management of pediatric MPP.

methodsA comprehensive literature search was conducted across PubMed, Embase, Web of Science Core Collection, Wanfang Data, Variant Impact Predictor database, and Chinese National Knowledge Infrastructure from the establishment of each database up to November 2025. Eligible studies were randomized controlled trials (RCTs) that compared azithromycin sequential monotherapy with azithromycin sequential therapy plus montelukast in pediatric patients diagnosed with MPP. Primary outcome measures included overall clinical efficacy, resolution time of key clinical symptoms (cough, wheezing, pulmonary rales, and fever), and the incidence of adverse events.

resultsThirty-six RCTs involving 3450 pediatric patients (1726 in the combination group and 1724 in the azithromycin group) met the inclusion criteria. Compared with azithromycin sequential therapy, combination therapy significantly improved overall clinical efficacy (odds ratio = 4.75, 95% confidence interval [CI]: 3.70-6.10). The addition of montelukast also shortened the resolution time of cough (mean difference [MD] = -3.63, 95% CI: -4.27 to -2.99), wheezing (MD = -1.48, 95% CI: -1.82 to -1.14), pulmonary rales (MD = -2.06, 95% CI: -2.54 to -1.57), and fever (MD = -1.43, 95% CI: -1.89 to -0.96). No significant difference in adverse event rates was observed between groups.

conclusionsAzithromycin sequential therapy combined with montelukast may provide additional therapeutic benefits for the treatment of pediatric MPP, characterized by higher overall clinical efficacy and more rapid resolution of clinical symptoms, without a statistically significant increase in short-term adverse events. Despite the encouraging findings, the included studies were predominantly single-center trials with moderate methodological quality. Therefore, well-designed, large-scale, multicenter RCTs are urgently needed to validate these results and provide more reliable evidence for guiding clinical decision-making.