Objective  To analyze the risk factors for adverse drug reactions (ADRs) caused by montelukast sodium in the treatment of children with community-acquired pneumonia (CAP), and to construct and verify prediction model for ADRs.

Methods  The clinical data of CAP children who received montelukast sodium treatment in Suzhou Hospital Affiliated to Anhui Medical University from April 2023 to June 2024 were retrospectively collected. The patients were randomly divided into modeling group and verification group according to the 3∶2 ratio, and the modeling group were divided into the ADR subgroup and non-ADR subgroup based on the presence or absence of ADR. The modeling group data was used for model construction, and multivariate Logistic analysis were used to analyze the influencing factors of ADR and establish a predictive model. The verification group data was used for model validation. The model’s predictive ability, calibration, and clinical net benefits were evaluated using the receiver operating characteristic (ROC) analysis, calibration curves, and decision curves.

Results  A total of 241 pediatric patients were included, including 144 in the modeling group and 97 in the validation group. A total of 50 children in the modeling group developed ADR, with an incidence rate of 34.72%. Multivariate Logistic regression results indicated that nebulized inhalation [OR=2.370, 95%CI (1.099, 5.111), P=0.028], use of methylprednisolone [OR=2.481, 95%CI (1.057, 5.824), P=0.037], and extrapulmonary complications [OR=7.411, 95% CI (1.382, 39.738), P=0.019] were independent risk factors for montelukast sodium related ADRs in children with CAP. The areas under the curve of the modeling group and validation group were 0.964 and 0.869, respectively. The calibration curve and decision curve showed good consistency between the predicted and actual values of the model, indicating good clinical net benefits.

Conclusions  Aerosol inhalation, methylprednisolone use, and extrapulmonary complications were independent risk factors for the occurrence of montelukast sodium-related adverse reactions in children with CAP. This model could help screen and identify ADR high-risk children.

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