目的 基于美国FDA不良事件报告系统（FAERS），评估和比较不同抗肿瘤单克隆抗体和细胞因子释放综合征之间的关系，以期为该类药物的安全合理使用提供参考。方法 收集FAERS建库至2024年第一季度以抗肿瘤单克隆抗体作为首要怀疑药物，细胞因子释放综合征作为首选术语的病例报告。采用报告比值比（ROR）和综合标准法（MHRA）研究抗肿瘤单克隆抗体与细胞因子释放综合征之间的关系，并进一步研究细胞因子释放综合征导致的严重结局和死亡率。结果 共收集到3 182份细胞因子释放综合征的报告，上报国家以美国为主（23.79%），上报人员以医务人员为主（95.76%）。患者年龄以18～64岁占比最高（35.42%），男性占比较女性高（49.31% vs 34.54%）。细胞因子释放综合征最常见报道为利妥昔单抗治疗（865例）；莫妥珠单抗在抗肿瘤单克隆抗体治疗中信号最强[ROR＝972.56，95% CI＝665.75～1 420.78；比例报告比值比法（PRR）＝748.85，χ²＝25 161.11]；细胞因子释放综合征相关死亡率以奥加伊妥珠单抗最高（31.25%）。结论 抗肿瘤单克隆抗体相关细胞因子释放综合征后果较为严重，临床在使用抗肿瘤单克隆抗体时应警惕患者发生细胞因子释放综合征的可能，尤其是患有血液系统肿瘤的患者。

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.

安徽医科大学校基金资助项目（2023xkj091）；亳州市人民医院院级科研项目（by2023006）