社区获得性肺炎患儿孟鲁司特钠相关不良反应预测模型的构建与验证  

Construction and validation of a predictive model for montelukast sodiumrelatedadverse reactions in children with community-acquired pneumonia

作　　者：孙萌萌 朱琳[1] 王宗燕 周碧 SUN Mengmeng;ZHU Lin;WANG Zongyan;ZHOU Bi(Department of Pediatric Infectious Diseases,Suzhou Hospital Affiliated to Anhui Medical University,Suzhou 234000,Anhui Province,China;Department of Pediatrics,Suzhou Hospital Affiliated to Anhui Medical University,Suzhou 234000,Anhui Province,China)

机构地区：[1]安徽医科大学附属宿州医院儿童感染科,安徽宿州234000 [2]安徽医科大学附属宿州医院儿科,安徽宿州234000

出　　处：《药物流行病学杂志》2025年第2期136-143,共8页Chinese Journal of Pharmacoepidemiology

基　　金：宿州市科技局自筹资金项目(SZZCZJ202328)。

摘　　要：目的分析孟鲁司特钠治疗社区获得性肺炎(CAP)患儿导致药品不良反应(ADR)的影响因素,构建并验证相关ADR发生的风险预测模型。方法回顾性收集2023年4月—2024年6月于安徽医科大学附属宿州医院接受孟鲁司特钠治疗的CAP患儿临床资料,按照3∶2的比例将患儿随机分为建模组与验证组,并根据是否出现ADR将建模组分为ADR亚组和非ADR亚组。建模组数据用于模型构建,采用多因素Logistic回归模型分析ADR的影响因素并建立预测模型,验证组用于模型验证。应用受试者工作特征曲线分析、校准曲线和决策曲线评估模型的预测能力、校准能力和临床净获益。结果共纳入241例患儿,其中建模组144例,验证组97例。建模组中50例患儿发生ADR,发生率为34.72%,多因素Logistic回归分析结果显示,雾化吸入[OR=2.370,95%CI(1.099,5.111),P=0.028]、使用甲泼尼龙[OR=2.481,95%CI(1.057,5.824),P=0.037]、肺外并发症[OR=7.411,95%CI(1.382,39.738),P=0.019]是CAP患儿孟鲁司特钠相关ADR发生的独立危险因素。基于上述危险因素构建列线图预测模型,建模组和验证组曲线下面积分别为0.964和0.869,校准曲线和决策曲线显示该模型预测值与实际值一致性良好,具有良好的临床净获益。结论雾化吸入、使用甲泼尼龙、肺外并发症是CAP患儿孟鲁司特钠相关ADR发生的独立危险因素,基于此建立的预测模型有助于筛选和识别ADR风险较高的患儿。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 r

关 键 词：孟鲁司特钠 社区获得性肺炎 药品不良反应 影响因素 预测模型 

分 类 号：R974.3[医药卫生—药品]