目的 系統(tǒng)分析順鉑治療非小細(xì)胞肺癌（NSCLC）的真實(shí)世界安全性，通過(guò)挖掘美國(guó)食品藥品監(jiān)督管理局不良事件報(bào)告系統(tǒng)（FAERS）長(zhǎng)達(dá)20年（2004—2024年）的數(shù)據(jù)，以識(shí)別常規(guī)臨床試驗(yàn)中易被忽視的罕見(jiàn)或長(zhǎng)期不良事件。方法 共納入995份不良反應(yīng)報(bào)告，采用描述性統(tǒng)計(jì)及報(bào)告比值比（ROR）等4種比例失調(diào)分析方法進(jìn)行信號(hào)檢測(cè)，并通過(guò)敏感性分析與加拿大警戒不良反應(yīng)數(shù)據(jù)庫(kù)（CVAROD）進(jìn)行外部驗(yàn)證。結(jié)果 除已知的骨髓抑制與腎毒性外，還識(shí)別出多個(gè)藥品說(shuō)明書(shū)未詳盡列出的潛在安全信號(hào)，如肺栓塞、感染性休克及房顫。亞組分析提示65歲及以上患者更易發(fā)生心血管系統(tǒng)并發(fā)癥。肺栓塞等關(guān)鍵信號(hào)在敏感性分析和外部驗(yàn)證中均得到支持，增強(qiáng)了其與順鉑的關(guān)聯(lián)性。結(jié)論 順鉑在真實(shí)世界中的安全風(fēng)險(xiǎn)譜比既往認(rèn)知更為廣泛。為臨床實(shí)踐中制定個(gè)體化的風(fēng)險(xiǎn)管理策略、優(yōu)化高危人群用藥方案提供了重要的循證依據(jù)。

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

吉林省科技廳發(fā)展計(jì)劃項(xiàng)目（YDZJ202501ZYTS267）