目的:对儿童使用替加环素发生不良反应(ADR)进行主动监测与风险因素评估。方法:通过医院信息系统(HIS)抽取我 院2023-2024 年使用替加环素的患儿信息、药物信息、用药前后的检验结果等进行ADR 主动监测,建立多因素回归模型探索替 加环素所致ADR 的风险因素。结果:我院2023-2024 年共有237 例患儿使用替加环素,其中85 例(35. 86%) 在替加环素应用 期间发生ADR。发生ADR 组和未发生ADR 组的替加环素用药疗程、是否合并血液系统疾病、是否联用抗肿瘤药物情况比较差 异有统计学意义(P<0. 05);进一步二元logistic 回归分析显示,替加环素用药疗程>7 d 和联用抗肿瘤药物是发生替加环素相关 ADR 的危险因素。结论:真实世界中,替加环素ADR 主动监测的儿童人群应为替加环素用药疗程>7 d,尤其是诊断血液系统疾 病且有可能联用抗肿瘤药物的患儿。
Objective: To perform active monitoring and risk factor assessment of adverse drug reactions (ADR) associated with tigecycline in children. Methods: The data on children administered tigecycline from 2023 to 2024 were extracted from the hospital information system (HIS), including general information, drug details, and laboratory results before and after administration. A multivariate regression model was established to assess risk factors for tigecycline-induced ADR. Results: A total of 237 children were treated with tigecycline in our hospital from 2023 to 2024, and 85 cases (35. 86%) developed ADR during tigecycline treatment. Significant differences were observed in tigecycline treatment course, presence of hematologic diseases, and combined use of anti-tumor drugs (P<0. 05). Further binary logistic regression analysis revealed that treatment course >7 d with tigecycline and the combined use of anti-tumor drugs were risk factors for tigecycline-induced ADR. Conclusion: In the real world, pediatric patients receiving tigecycline for >7 d, particularly those diagnosed with hematologic diseases and potentially requiring anti-tumor drugs should be prioritized for active ADR monitoring.