目的 基于美國FDA不良事件報(bào)告系統(tǒng)（FAERS），評(píng)估和比較不同抗腫瘤單克隆抗體和細(xì)胞因子釋放綜合征之間的關(guān)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(xì)胞因子釋放綜合征作為首選術(shù)語的病例報(bào)告。采用報(bào)告比值比（ROR）和綜合標(biāo)準(zhǔn)法（MHRA）研究抗腫瘤單克隆抗體與細(xì)胞因子釋放綜合征之間的關(guān)系，并進(jìn)一步研究細(xì)胞因子釋放綜合征導(dǎo)致的嚴(yán)重結(jié)局和死亡率。結(jié)果 共收集到3 182份細(xì)胞因子釋放綜合征的報(bào)告，上報(bào)國家以美國為主（23.79%），上報(bào)人員以醫(yī)務(wù)人員為主（95.76%）。患者年齡以18～64歲占比最高（35.42%），男性占比較女性高（49.31% vs 34.54%）。細(xì)胞因子釋放綜合征最常見報(bào)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(hào)最強(qiáng)[ROR＝972.56，95% CI＝665.75～1 420.78；比例報(bào)告比值比法（PRR）＝748.85，χ²＝25 161.11]；細(xì)胞因子釋放綜合征相關(guān)死亡率以奧加伊妥珠單抗最高（31.25%）。結(jié)論 抗腫瘤單克隆抗體相關(guān)細(xì)胞因子釋放綜合征后果較為嚴(yán)重，臨床在使用抗腫瘤單克隆抗體時(shí)應(yīng)警惕患者發(fā)生細(xì)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(xué)?；鹳Y助項(xiàng)目（2023xkj091）；亳州市人民醫(yī)院院級(jí)科研項(xiàng)目（by2023006）