| 苏珊,刘加葳,王春敏,等.基于美国 FDA不良事件报告系统数据库的普拉替尼不良事件信号挖掘与分析[J].安徽医药,2025,29(7):1478-1484. |
| 基于美国 FDA不良事件报告系统数据库的普拉替尼不良事件信号挖掘与分析 |
| Mining and analysis of ADE signals of pralsetinib based on FDA adverse event reporting system database |
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| DOI：10.3969/j.issn.1009-6469.2025.07.043 |
| 中文关键词: 药品不良事件 药物相关性副作用和不良反应 普拉替尼 信号挖掘 美国 FDA不良事件报告系统(FAERS) 药物警戒 |
| 英文关键词: Adverse drug event Drug-related side effects and adverse reactions Pralsetinib Data mining US FDA adverse event reporting system database(FAERS) Pharmacovigilance |
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| 中文摘要: |
| 目的挖掘并分析普拉替尼上市后的药物不良事件(ADE)信号，为临床安全使用普拉替尼提供参考。方法收集美国 FDA不良事件报告系统( FAERS)数据库中 2020年第 4季度至 2023年第 4季度的普拉替尼的 ADE报告，采用报告比值比(ROR)、比例报告比值比( PRR)、贝叶斯置信传播神经网络法( BCPNN)法和多项伽马 -泊松压缩估计法( MGPS)进行数据挖掘与分析。结果共检测到 ADE风险信号 83个，累及 19个系统和器官分类( SOC)。发生例次较多的 ADE信号与药品说明书基本一致，如高血压、乏力、白细胞计数降低等；临床需重点关注的新的 ADE风险信号主要有血降钙素升高、心肌坏死标志物升高、乙型肝炎、肺结核等。结论对于普拉替尼发生例次较高且已载入药品说明书的 ADE(如高血压、乏力、白细胞计数降低等)，在用药前应做好充分评估，尤其是伴有基础高血压的病人；对于信号强度高的、新的 ADE信号，如血降钙素升高、心肌坏死标志物增加、乙型肝炎、肺结核等，临床医生及药师应高度警惕，用药过程中若发现相关症状，应及时做好鉴别诊断，积极治疗，以保证病人用药安全。 |
| 英文摘要: |
| Objective To mine and analyze adverse drug event (ADE) signals after the marketing of pralsetinib and to provide refer-ence for clinically safe medication.Methods ADE data for pralsetinib drug event were collected from the US FDA Adverse Event Re-porting System (FAERS) database from the fourth quarter of 2020 to the fourth quarter of 2023. The data were mined and analyzed by uti-lizing the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) andmulti-item gamma Poisson shrinker (MGPS).Results A total of 83 ADE risk signals were detected including 19 system and organ clas-sifications (SOC). ADE risk signals that occurred more frequently were generally consistent with what was included in the drug instruc-tion, such as hypertension, asthenia and lowered white blood cell count, etc. The new ADE risk signals requiring clinical attention were elevated blood calcitonin, elevated markers of myocardial necrosis, hepatitis B and tuberculosis. Conclusions For ADEs that occur more frequently with pralsetinib and have been included in the drug instruction (e.g. hypertension, asthenia and lowered white blood cellcount), they should be adequately evaluated before administration, especially for patients with underlying hypertension; for new ADE sig-nals with high signal intensity, such as elevated blood calcitonin, increased myocardial necrosis markers, hepatitis B, tuberculosis, etc.,clinicians and pharmacists should be highly vigilant. If relevant symptoms are found during medication administration, differential diag-nosis should be done in a timely manner and active treatment should be carried out to ensure patients' medication safety. |
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