| 摘要: |
| 摘要 目的 本研究借助于FAERS数据库收录的药物相关AEs开展药物相关ADR信号的检测分析，旨在为FGFR抑制剂类药物的上市后安全性提供见解，并为临床医生、患者及监管机构提供个性化治疗决策依据。方法 通过FAERS数据库，使用在线平台Open Vigil 2.1对FGFR抑制剂类药物相关AEs进行检索。该查询覆盖2019年1月1日至2025年3月31日期间，提取所有关于英菲格拉替尼、佩米替尼、厄达替尼和富巴替尼的AEs报告，并进行了回顾性定量分析。采用ROR与PRR两种方法，对四种FGFR抑制剂类药物的AEs进行对比分析。结果 共识别到67份英菲格拉替尼AEs报告、662份佩米替尼报告、1049份厄达替尼报告及132份富巴替尼报告；除厄达替尼报告中男性明显多于女性，其他三类药物女性患者略多于男性，其中提交的报告来自于美国的数量最多；药物AEs涉及年龄分组主要以18-64岁与65-85岁两个年龄段；胃肠道疾病是四种药物最常见的AE类别，但各药物在该分类下的占比存在显著差异，占比大小依次为英非替拉尼＞富巴替尼＞佩米替尼＞厄达替尼；英菲格拉替尼共筛选出30个ADR阳性信号，其中腹泻、肌痛和脱发信号强度最为显著。佩米替尼筛选出84个阳性信号，厄达替尼筛选出82个阳性信号，富巴替尼筛选出20个阳性信号，三者信号强度最高的PT均为高磷酸盐血症、血磷升高和甲松离。结论 四种FGFR抑制剂类药物AEs涉及多个系统，包括胃肠道、皮肤及皮下组织疾病、代谢和营养障碍性疾病等。临床实践中尤其应当注意此类药物导致的高磷酸盐血症、皮肤毒性、眼部疾病以及可能会导致的钙沉积障碍。 |
| 关键词: FGFR抑制剂类药物 不良事件 美国食品药品管理局不良反应监测系统 高磷酸盐血症 皮肤毒性 |
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| FGFR Inhibitors Adverse Drug Reaction Signal Detection and Analysis Based on FAERS |
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曹单单1,2,3, YANG Xiaojuan4
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1.Xiaoxian People'2.'3.s Hospital;4.Wanbei Coal-electricity Group General Hospital
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| Abstract: |
| Abstract Objective This study aims to provide insights into the post-marketing safety of FGFR inhibitor drugs and offer personalized treatment decision-making basis for clinicians, patients, and regulatory agencies by detecting and analyzing drug-related adverse drug reactions (ADRs) using the FDA Adverse Event Reporting System (FAERS) database. Methods The FAERS database was accessed through the online platform Open Vigil 2.1 to retrieve AEs related to FGFR inhibitors. The query covered reports from January 1, 2019, to March 31, 2025, extracting all AEs reports on Infigratinib, Pemigatinib, Erdafitinib, and Futibatinib for retrospective quantitative analysis. ROR and PRR methods were employed to compare and analyze the AEs of the four FGFR inhibitors. Results A total of 67 Infigratinib AE reports, 662 Pemigatinib reports, 1049 Erdafitinib reports, and 132 Futibatinib reports were identified. Except for Erdafitinib reports, where males significantly outnumbered females, the other three types of drugs had slightly more female patients, with the majority of reports coming from the United States. The age distribution of drug AEs mainly involved two age groups: 18-64 years and 65-85 years. Gastrointestinal diseases were the most common AE category for all four drugs, but the proportion varied significantly among them, ranked as Infigratinib > Futibatinib > Pemigatinib > Erdafitinib. Infigratinib identified 30 ADR positive signals, with diarrhea, myalgia, and alopecia being the most significant. Pemigatinib identified 84 positive signals, Erdafitinib identified 82 positive signals, and Futibatinib identified 20 positive signals, with the highest signal strength PT for all three being hyperphosphatemia, elevated blood phosphorus, and onycholysis. Conclusion The AEs of the four FGFR inhibitor drugs involve multiple systems, including the gastrointestinal tract, skin and subcutaneous tissue diseases, metabolic and nutritional disorders, etc. In particular, attention should be paid to hyperphosphatemia, skin toxicity, eye disease and possible calcium deposition disorders caused by these drugs in clinical practice. |
| Key words: FGFR inhibitor drugs/ Adverse events/ FDA Adverse Event Reporting System/ Hyperphosphatemia/ Skin toxicity |