目的 系统分析顺铂治疗非小细胞肺癌（NSCLC）的真实世界安全性，通过挖掘美国食品药品监督管理局不良事件报告系统（FAERS）长达20年（2004—2024年）的数据，以识别常规临床试验中易被忽视的罕见或长期不良事件。方法 共纳入995份不良反应报告，采用描述性统计及报告比值比（ROR）等4种比例失调分析方法进行信号检测，并通过敏感性分析与加拿大警戒不良反应数据库（CVAROD）进行外部验证。结果 除已知的骨髓抑制与肾毒性外，还识别出多个药品说明书未详尽列出的潜在安全信号，如肺栓塞、感染性休克及房颤。亚组分析提示65岁及以上患者更易发生心血管系统并发症。肺栓塞等关键信号在敏感性分析和外部验证中均得到支持，增强了其与顺铂的关联性。结论 顺铂在真实世界中的安全风险谱比既往认知更为广泛。为临床实践中制定个体化的风险管理策略、优化高危人群用药方案提供了重要的循证依据。

Objective To systematically analyze the real-world safety of cisplatin for treating non-small cell lung cancer (NSCLC) by analyzing 20 years of data (from 2004 to 2024) from the FDA Adverse Event Reporting System (FAERS) to identify rare or long-term adverse events often overlooked in clinical trials. Methods A total of 995 adverse event reports were evaluated using descriptive statistics and four disproportionality analysis methods, including the reporting odds ratio (ROR). Sensitivity analysis was performed by excluding common concomitant medications, and external validation was conducted using CVAROD. Results In addition to wellknown adverse events such as myelosuppression and nephrotoxicity, potential new safety signals not fully detailed on the drug label were identified, including pulmonary embolism, septic shock, and atrial fibrillation. Subgroup analysis indicated that patients aged 65 years and older were at a higher risk of cardiovascular complications. Key signals such as pulmonary embolism were supported by both sensitivity analysis and external validation, strengthening their association with cisplatin. Conclusion The safety risk profile of cisplatin in a real-world setting is broader than previously understood. This study provides a critical evidence base for developing individualized risk management strategies and optimizing treatment plans for high-risk populations in clinical practice.

R979.1

吉林省科技厅发展计划项目（YDZJ202501ZYTS267）