| アブストラクト | Head and neck cancers (HNCs) affect approximately 650,000 individuals annually worldwide, with cisplatin, docetaxel, and fluorouracil serving as cornerstone agents in the widely employed Taxane [docetaxel], Platinum [cisplatin], and Fluorouracil (TPF) regimen; however, despite their demonstrated survival benefits, a comprehensive comparative pharmacovigilance analysis quantifying the distinctive safety profiles and adverse drug reaction (ADR) burdens of these agents remains absent from the literature. This study aimed to conduct a systematic pharmacovigilance analysis using the EudraVigilance database to quantify drug-specific safety signals and characterize comparative toxicity profiles of cisplatin, docetaxel, and fluorouracil through rigorous disproportionality methodologies. Analysis of 244,769 ADR reports revealed markedly distinct toxicity profiles: cisplatin demonstrated the highest death reporting rate (0.56 %) and exhibited disproportionately elevated associations with renal and urinary disorders (ROR: 5.96, 95 % CI: 5.57-6.37) and ear and labyrinth disorders (ROR: 10.80, 95 % CI: 9.35-12.47), with nephrotoxicity, ototoxicity, neutropenia (4.19 %), and myelosuppression (4.07 %) representing its characteristic profile. Docetaxel revealed an extraordinary psychiatric burden previously underappreciated in clinical trials, showing a 20.67-fold increased signal for psychiatric disorders (95 % CI: 19.20-22.26) and 34.28-fold association with adverse social circumstances (95 % CI: 27.69-42.44), with alopecia (12.99 %), psychological trauma (5.82 %), and emotional distress (4.03 %) constituting the most common adverse reactions, alongside prominent skin and subcutaneous tissue disorders (18.55 %). Fluorouracil demonstrated distinctive cardiovascular toxicities including coronary arteriospasm and cardiogenic shock (ROR: 1.71, 95 % CI: 1.46-2.01), the highest bone marrow suppression rate (5.73 %), and extensive gastrointestinal manifestations including ischemic colitis and hemorrhagic diarrhea. Additionally, 116 common ADR signals were identified across all three agents, predominantly hematological toxicities distributed across 18 System Organ Classes (SOCs). These quantified safety signals provide clinically actionable intelligence for evidence-based risk stratification, enabling personalized treatment selection based on patient-specific vulnerability profiles, proactive implementation of targeted toxicity mitigation strategies including renal protection for cisplatin recipients, psychological support for docetaxel-treated patients, and cardiac monitoring for fluorouracil administration, ultimately transforming empirical clinical practice into precision pharmacovigilance for optimized therapeutic outcomes in HNC management. |
|---|
| 組織名 | Stomatological Hospital, School of Stomatology, Southern Medical University, S366;Jiangnan Boulevard, Haizhu District, Guangzhou, 510280, Guangdong Province,;China. Electronic address: simin.li.dentist@gmail.com.;China. Electronic address: zhangxiong2000@126.com.;China. Electronic address: 876246732@qq.com.;China. Electronic address: shaonan_hu@smu.edu.cn.;Department of Conservative Dentistry and Periodontology, Brandenburg Medical;School Theodor Fontane (MHB), Havel, Brandenburg, Germany. Electronic address:;deborah.kreher@mhb-fontane.de.;gerhard.schmalz@mhb-fontane.de.;China. Electronic address: zzmmxh@126.com. |
|---|
