芬氟拉明上市后药物警戒研究：基于美国食品药品监督管理局公共数据开放项目（openFDA）的不良事件数据挖掘与分析

IF 3.2 3区医学 Q2 CLINICAL NEUROLOGY

Pediatric neurology Pub Date : 2025-03-08 DOI:10.1016/j.pediatrneurol.2025.03.001

Tianyu Chen MNS , Qiying Chen BM , Yuezhen Zhang BM , Ting Liu BM

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引用次数: 0

摘要

使用美国食品和药物管理局的公开公共数据计划（openFDA）对芬氟拉明（FFA）相关的不良事件（ae）进行了上市后分析。方法查询openFDA数据库，检索FFA AE报告。采用报告优势比（ROR）和比例报告比两种算法检测潜在安全信号。结果在开放fda数据平台中，研究期间共收集AE报告6269521份；以FFA为主要嫌疑的AE报告数量为2386例。其中，消费者或非卫生专业人员报告1526例（63.96%），美国报告2009例（84.20%），适应症不明1053例（44.13%），严重ae报告1315例（55.11%）。共产生62个信号。十大信号包括清音癫痫(ROR 918.52, 95%可信区间[CI]: 670.65 - -1257.99),癫痫集群(ROR 787.02, 95%置信区间CI: 595.26 - -1040.56),二尖瓣增厚(ROR 773.94, 95%置信区间CI: 463.47 - -1292.38),肺动脉瓣无能(ROR 600.71, 95%置信区间CI: 432.09 - -835.13),超声心动图异常(ROR 417.13, 95%置信区间CI: 307.87 - -565.16),发作变化演示(ROR 287.55, 95%置信区间CI: 214.81 - -384.91),三尖瓣无能(ROR 221.42, 95%置信区间CI:179.68-272.84)、主动脉瓣功能不全（ROR为176.59,95% CI: 131.89-236.45）、强直性惊厥（ROR为173.68,95% CI: 110.28-273.54）和肌阵挛性癫痫（ROR为158.05,95% CI: 102.60-243.46）。本研究采用openFDA数据库识别与FFA相关的安全信号，从而为接受FFA治疗的患者的临床监测和风险识别提供重要见解。

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A Postmarketing Pharmacovigilance Study of Fenfluramine: Adverse Event Data Mining and Analysis Based on the US Food and Drug Administration Public Data Open Project (openFDA)

Background

A postmarketing analysis of the adverse events (AEs) associated with fenfluramine (FFA) was conducted using the US Food and Drug Administration's Open Public Data Program (openFDA).

Methods

The openFDA database was queried to retrieve FFA AE reports. Two algorithms, namely, the reporting odds ratio (ROR) and proportional reporting ratio, were employed for the purpose of detecting potential safety signals.

Results

From the openFDA data platform, a total of 6,269,521 AE reports were collected during the study period; the number of AE reports with FFA as the primary suspect was 2386. Of these, 1526 (63.96%) were reported by consumers or non–health professionals, 2009 (84.20%) were reported by the United States, 1053 (44.13%) were unknown indications, and serious AEs were reported in 1315 cases (55.11%). A total of 62 signals were generated. The top 10 signals included atonic seizures (ROR of 918.52, 95% confidence interval [CI]: 670.65-1257.99), seizure clusters (ROR of 787.02, 95% CI: 595.26-1040.56), mitral valve thickening (ROR of 773.94, 95% CI: 463.47-1292.38), pulmonary valve incompetence (ROR of 600.71, 95% CI: 432.09-835.13), echocardiogram abnormal (ROR of 417.13, 95% CI: 307.87-565.16), change in seizure presentation (ROR of 287.55, 95% CI: 214.81-384.91), tricuspid valve incompetence (ROR of 221.42, 95% CI: 179.68-272.84), aortic valve incompetence (ROR of 176.59, 95% CI: 131.89-236.45), tonic convulsion (ROR of 173.68, 95% CI: 110.28-273.54), and myoclonic epilepsy (ROR of 158.05, 95% CI: 102.60-243.46).

Conclusions

This study employed the openFDA database to identify safety signals associated with FFA, thereby offering significant insights for clinical monitoring and risk identification in patients undergoing FFA therapy.

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来源期刊

Pediatric neurology 医学-临床神经学

CiteScore

4.80

自引率

2.60%

发文量

176

审稿时长

78 days

期刊介绍： Pediatric Neurology publishes timely peer-reviewed clinical and research articles covering all aspects of the developing nervous system. Pediatric Neurology features up-to-the-minute publication of the latest advances in the diagnosis, management, and treatment of pediatric neurologic disorders. The journal''s editor, E. Steve Roach, in conjunction with the team of Associate Editors, heads an internationally recognized editorial board, ensuring the most authoritative and extensive coverage of the field. Among the topics covered are: epilepsy, mitochondrial diseases, congenital malformations, chromosomopathies, peripheral neuropathies, perinatal and childhood stroke, cerebral palsy, as well as other diseases affecting the developing nervous system.