目的 观察儿童服用孟鲁司特钠出现的不良反应（ADR），并确定其相关影响因素。方法 随访调查山东大学附属儿童医院门诊及住院2020年7月1日—12月31日530例患者服用孟鲁司特钠药物后出现ADR情况，对其影响因素进行分析。结果 530例调查对象中，有45例患者报告了ADR，ADR发生的最短时间为用药后1 h、最长时间为用药2年后，主要涉及精神系统紊乱、胃肠道功能紊乱、血液和淋巴系统紊乱、皮肤和皮下组织紊乱，检出率分别为5.85%、1.70%、1.32%、1.13%。患儿年龄、性别、服用剂量、服用剂型、是否联合用药与ADR发生无明显相关（P＞0.05），连续用药时间与ADR发生率存在显著性相关（P＜0.05），77.1%的儿童ADR发生在服药1个月内。结论 孟鲁司特钠ADR涉及全身多个系统，主要以精神症状为主，且未见严重不良反应。

Objective To observe the adverse reactions (ADRs) of children taking montelukast sodium and determine its related influencing factors. Methods A follow-up survey was conducted on 530 patients who developed ADR after taking montelukast sodium in the outpatient and inpatient departments of Shandong University Affiliated Children's Hospital from July 1, 2020 to December 31, 2020. The influencing factors were analyzed. Results Among the 530 survey subjects, 45 patients reported ADR. The shortest time for ADR occurrence was one hour after medication, and the longest time was two years after medication. It mainly involves nervous system disorders, gastrointestinal dysfunction, blood and lymphatic system disorders, skin and subcutaneous tissue disorders, with detection rates of 5.85%, 1.70%, 1.32%, and 1.13%, respectively. There was no significant correlation between the age, gender, dosage, dosage form, and combination therapy of the patient and the occurrence of ADR (P＞0.05). There was a significant correlation (P＜0.05) between the duration of continuous medication and the incidence of ADR, with 77.1% of children experiencing ADR within one month of medication. Conclusion Montelukast sodium ADR involves multiple systems throughout the body, mainly characterized by psychiatric symptoms, and no serious adverse reactions were observed.

R969.3

济南市临床医学科技创新计划（202134067，202225022）；济南市卫生健康委员会大数据科技计划项目（2022-BD-13，2023-YBD-1-06）；山东省儿童健康与疾病临床医学研究中心（SDPRC009）；山东省自然科学基金项目（ZR2021MH147）