摘要
目的 基于美国食品药品监督管理局不良事件呈报系统(FAERS),挖掘药物在0~18岁儿童临床使用中引起血小板减少症的警戒信号,为判断和治疗临床不明原因血小板减少提供参考。方法 用Open Vigil 2.1软件对FAERS数据库进行药源性血小板减少症不良反应数据挖掘,以“thrombocytopenia”为首选术语进行检索,采用比例报告比(PRR)和报告比值比法(ROR)对药源性血小板减少症警戒信号进行数据分析和处置。结果 根据预定义的纳入标准,2 510例不良事件(ADE)报告涉及鉴定出435种疑似药物,经过数据挖掘,生成54种药源性血小板减少症的阳性风险信号,其中36种是抗肿瘤药物。报告最多的药物是甲氨蝶呤(n=113)、其次是丙戊酸(n=67)、多柔比星(n=52)、阿糖胞苷(n=51)和依托泊苷(n=46)。地西他滨(PRR=27.18,ROR=32.5)、硫鸟嘌呤(PRR=22.96,ROR=26.62)、吉西他滨(PRR=17.85,ROR=19.94),和奥沙利铂(PRR=16.79,ROR=18.63)与血小板减少的关系比其余的药物更强。结论 引起儿童药源性血小板减少症的药物主要包括抗肿瘤药物、神经系统药物及抗感染药物3大类,关注其引起儿童药源性血小板减少症的特点,对相关药物风险进行识别与比较,持续监测该ADE,进而有效降低临床用药风险。
Objective To explore the risk assessment of drugs use in children aged 0—18 years induced thrombocytopenia in the clinical,and provide a reference for judgment and treatment of clinical thrombocytopenia of unknown cause using the data of the US Food and Drug Administration’s Adverse Event Reporting System(FAERS).Methods Drug induced thrombocytopenia data mining was performed in FAERS database by OpenVigil 2.1 software,“thrombocytopenial”were used as the preferred terms for retrieval,and the thrombocytopenia caused by antitumor and antiepileptic medicines was detected by proportional reporting ratio(PRR)and reported ratio method(ROR).Results Based on predefined inclusion criteria,2510 ADE reports involving 435 suspected drugs were identified.After data mining,54 drugs generated positive risk signals for drug-induced thrombocytopenia,of which 36 were antitumors for systemic use.The top reported drug was methotrexate(n=113),followed by valproic acid(n=65),doxorubicine(n=51),cytarabine(n=48)and etoposide(n=44).Decitabine(PRR=27.18,ROR=32.5),thioguanine(PRR=22.96,ROR=26.62),gemcitabine(PRR=17.85,ROR=19.94)and oxaliplatin(PRR=16.79,ROR=18.63)showed stronger associations with DIT than the remaining drugs.Conclusion Through the mining and analysis of FAERS date,it was found that drugs causing thrombocytopenia in children include antitumor drugs,nervous system drugs and antibacterial drugs.Pay attention to the characteristics of drug induced thrombocytopenia in children,identify and compare the risks of related drugs,and continuously monitor the adverse events,so as to effectively reduce the risk of clinical drug use.
作者
张静
郝丽娜
ZHANG Jing;HAO Lina(Department of Pharmacy,Children's Hospital Affiliated to Shandong University(Jinan Children's Hospital),Jinan 250022,China)
出处
《药物评价研究》
北大核心
2025年第4期964-970,共7页
Drug Evaluation Research
