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目的 分析真实世界中儿童使用达沙替尼发生药物不良事件（ADE）的相关情况，为临床合理用药提供参考。方法 检索FDA不良事件报告系统（FAERS）数据库中2006年第2季度至2024年第2季度的18岁以下儿童数据，采用报告比值比（ROR）法和比例报告比（PRR）法对达沙替尼相关ADE进行信号挖掘，并按照报告数和信号强度排序。结果 共收集1 060份以达沙替尼为首要怀疑药物的ADE报告，涉及患儿424例。挖掘出达沙替尼相关首选术语（PT）50个，累及系统器官分类（SOC）12个。其中3个ADE信号未被药品说明书收载，分别为低钠血症（9例）、生长迟缓（10例）和脑积水（4例）。在记录有详细的服药时间信息的132例病例中，42例（占31.8%）ADE发生在达沙替尼使用后的1个月内，ADE中位诱发时间为53 d。与成人相比，胸腔积液在患儿中信号强度较低，报告数较少。结论 警惕达沙替尼说明书中未提及的ADE信号，尤其须关注生长发育迟缓。儿童相关ADE的风险在治疗早期增加。与成人相比，患儿胸腔积液的发生率更低。
Abstract：AIM To mine and analyze dasatinib-associated adverse drug events(ADEs) of pediatric patients in real-world scenatios, informing clinical strategies for safer pharmacotherapy. METHODS Cases of dasatinib for pediatric patients were retrieved based on the FDA adverse event reporting system(FAERS) data from Q2/2006 to Q2/2024. The reporting odds ratio(ROR) method and the proportional reporting ratio(PRR) from disproportionality analysis were used to detect the signal of ADEs. ADE signals were prioritized through signal frequency and signal intensity. RESULTS A total of 1060 ADE reports(including 424 pediatric cases) with 50 preferred terms(PT) involving 12 system organ classes(SOCs) were identified. Undocumented ADEs like hyponatremia(9 cases), growth retardation(10 cases) and hydrocephalus(4 cases) were observed. Temporal analysis revealed 31.8%(42/132) of ADEs occurred within the first treatment month, with a median time-to-onset of 53 days. Pharmacovigilance analysis revealed significantly attenuated signal intensity and fewer reported cases for pleural effusion in pediatric populations compared to adults. CONCLUSION During clinical use of dasatinib, attention should be paid to non-labeled ADEs associated with dasatinib therapy, particularly growth retardation parameters. The risk of pediatric ADEs associated with dasatinib increases in the early stages of treatment and requires more attention in clinical treatment. Compared with adults, the incidence of pleural effusion was lower in pediatric patients.
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基本信息:
DOI：10.19577/j.1007-4406.2025.06.005
中图分类号:R969.3
引用信息:
[1]耿娜,刘博宇,张晓红,等.基于FAERS数据库的儿童达沙替尼不良事件信号挖掘与分析[J].中国临床药学杂志,2025,34(06):431-436.DOI:10.19577/j.1007-4406.2025.06.005.
基金信息:
北京市自然科学基金面上项目（编号7242210）