目的 基于美國FDA不良事件報告系統(tǒng)（FAERS），評估和比較不同抗腫瘤單克隆抗體和細胞因子釋放綜合征之間的關系，以期為該類藥物的安全合理使用提供參考。方法 收集FAERS建庫至2024年第一季度以抗腫瘤單克隆抗體作為首要懷疑藥物，細胞因子釋放綜合征作為首選術語的病例報告。采用報告比值比（ROR）和綜合標準法（MHRA）研究抗腫瘤單克隆抗體與細胞因子釋放綜合征之間的關系，并進一步研究細胞因子釋放綜合征導致的嚴重結局和死亡率。結果 共收集到3 182份細胞因子釋放綜合征的報告，上報國家以美國為主（23.79%），上報人員以醫(yī)務人員為主（95.76%）?；颊吣挲g以18～64歲占比最高（35.42%），男性占比較女性高（49.31% vs 34.54%）。細胞因子釋放綜合征最常見報道為利妥昔單抗治療（865例）；莫妥珠單抗在抗腫瘤單克隆抗體治療中信號最強[ROR＝972.56，95% CI＝665.75～1 420.78；比例報告比值比法（PRR）＝748.85，χ²＝25 161.11]；細胞因子釋放綜合征相關死亡率以奧加伊妥珠單抗最高（31.25%）。結論 抗腫瘤單克隆抗體相關細胞因子釋放綜合征后果較為嚴重，臨床在使用抗腫瘤單克隆抗體時應警惕患者發(fā)生細胞因子釋放綜合征的可能，尤其是患有血液系統(tǒng)腫瘤的患者。

Objective To evaluate and compare the relationship between different anti-tumor monoclonal antibodies and cytokine release syndrome based on the data of FAERS, and to provide a reference for the safe clinical use of anti-tumor monoclonal antibodies. Methods Case reports were collected from FAERS database construction to the first quarter of 2024, with anti-tumor monoclonal antibodies as the primary suspected drug and cytokine release syndrome as the preferred term. The relationship between anti-tumor monoclonal antibodies and cytokine release syndrome was studied using reporting odds ratio (ROR) method and medicines and healthcare products regulatory agency (MHRA) method, and further investigation was conducted on the severe outcomes and mortality caused by cytokine release syndrome. Results A total of 3 182 reports of cytokine release syndrome were included. The reporting country was mainly the United States (23.79%), and the reporting personnel were mainly medical personnel (95.76%). The highest proportion of people aged 18-64 (35.42%). Males accounting for a higher proportion than females (49.31% vs 34.54%). The most common reports of cytokine release syndrome are the treatment with rituximab (865 cases); Mosunetuzumab has the strongest signal in anti-tumor monoclonal antibodies therapy [(ROR=972.56, 95%CI=665.75-1 420.78; PRR=748.85, χ²=25 161.11)]. The mortality rate associated with cytokine release syndrome was highest with the treatment of inotuzumab ozogamicin (31.25%). Conclusion The consequences of cytokine release syndrome related to anti-tumor monoclonal antibodies are relatively serious. When using anti-tumor monoclonal antibodies in clinical practice, patients should be alert to the possibility of cytokine release syndrome, especially those with hematological tumors.

安徽醫(yī)科大學?；鹳Y助項目（2023xkj091）；亳州市人民醫(yī)院院級科研項目（by2023006）