摘要
目的分析本院自发上报的严重药品不良反应(SADR)数据,为临床药品安全性评价和药物风险预警提供参考依据。方法采用回顾性分析方法,收集2019年1月至2024年12月通过中国医院药物警戒系统(CHPS)上报的SADR报告,对报告数量、报告者、患者基本信息、药品品种、不良反应类型等进行描述性统计分析。结果共纳入379例SADR报告,男女比例约3∶2,1岁以下患儿占比18.73%。给药途径以静脉滴注为主(78.91%),抗感染药物(32.78%)是仅次于抗肿瘤药物(52.39%)主要怀疑药物。其中,头孢曲松相关SADR表现较为突出,共观察到5例严重速发型过敏样反应及3例结石相关不良反应。不良反应累及系统器官分类的前5位依次为皮肤及皮下组织疾病、血液及淋巴系统疾病、胃肠系统疾病、神经系统疾病及肝胆系统疾病。结论抗肿瘤药物和抗感染药物是引起儿童SADR的主要致因,其不良反应主要表现为皮肤及皮下组织损害、血液及淋巴系统异常。临床实践中应重点强化这两类药物,特别是头孢曲松等高风险药物的用药监测,以有效降低SADR对患者的危害。
OBJECTIVE To analyze the data of serious adverse drug reactions(SADR)spontaneously reported in our hospital to provide a reference basis for clinical drug safety evaluation and drug risk early warning.METHODS A retrospective analysis was used to collect SADR reports reported through the China Hospital Pharmacovigilance System(CHPS)from January 2019 to December 2024,and descriptive statistics were analyzed for the number of reports,reporters,basic information of patients,drug species,and types of adverse reactions.RESULTS A total of 379 SADR reports were included,with a male-to-female ratio of approximately 3∶2 and 18.73%of children under 1 year of age.The route of administration was predominantly intravenous(78.91%),and anti-infective drugs(32.78%)were the main suspected drugs after antineoplastic drugs(52.39%).Among them,ceftriaxone-related SADR was more prominent,with five cases of severe rapid-onset anaphylactic-like reactions and three cases of stone-related adverse reactions observed.The top 5 classifications of system and organ involved in adverse reactions were skin and subcutaneous tissue diseases,blood and lymphatic system diseases,gastrointestinal system diseases,neurological system diseases,and hepato-biliary system diseases,in that order.CONCLUSION Anti-tumor drugs and anti-infective drugs are the main causes of SADR in children,and their adverse reactions are mainly manifested as skin and subcutaneous tissue damage and blood and lymphatic system abnormalities.Clinical practice should focus on strengthening the medication monitoring of these two types of drugs,especially high-risk drugs such as ceftriaxone,in order to effectively reduce the harm of SADR to patients.
作者
宋颖
王幼鸿
林金香
胡高声
SONG Ying;WANG You-hong;LIN Jin-xiang;HU Gao-sheng(Xiamen Children's Hospital,Children's Hospital of Fudan University(Xiamen Branch),Xiamen 361006,China)
出处
《海峡药学》
2025年第12期110-114,共5页
Strait Pharmaceutical Journal
基金
厦门市医疗卫生指导性项目(3502Z20224ZD1269)。
关键词
儿童
抗感染药物
抗肿瘤药物
药品不良反应
Children
Anti-infective Drugs
Antineoplastic Drugs
Adverse Drug Reactions
