目的 觀察兒童服用孟魯司特鈉出現(xiàn)的不良反應(yīng)（ADR），并確定其相關(guān)影響因素。方法 隨訪調(diào)查山東大學(xué)附屬兒童醫(yī)院門診及住院2020年7月1日—12月31日530例患者服用孟魯司特鈉藥物后出現(xiàn)ADR情況，對其影響因素進行分析。結(jié)果 530例調(diào)查對象中，有45例患者報告了ADR，ADR發(fā)生的最短時間為用藥后1 h、最長時間為用藥2年后，主要涉及精神系統(tǒng)紊亂、胃腸道功能紊亂、血液和淋巴系統(tǒng)紊亂、皮膚和皮下組織紊亂，檢出率分別為5.85%、1.70%、1.32%、1.13%?；純耗挲g、性別、服用劑量、服用劑型、是否聯(lián)合用藥與ADR發(fā)生無明顯相關(guān)（P＞0.05），連續(xù)用藥時間與ADR發(fā)生率存在顯著性相關(guān)（P＜0.05），77.1%的兒童ADR發(fā)生在服藥1個月內(nèi)。結(jié)論 孟魯司特鈉ADR涉及全身多個系統(tǒng)，主要以精神癥狀為主，且未見嚴重不良反應(yīng)。

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

濟南市臨床醫(yī)學(xué)科技創(chuàng)新計劃（202134067，202225022）；濟南市衛(wèi)生健康委員會大數(shù)據(jù)科技計劃項目（2022-BD-13，2023-YBD-1-06）；山東省兒童健康與疾病臨床醫(yī)學(xué)研究中心（SDPRC009）；山東省自然科學(xué)基金項目（ZR2021MH147）