周雨婷 朱斌 马雁

摘 要 双特异性抗体现已成为肿瘤免疫治疗药物的热点，而其诱发的与免疫相关的细胞因子释放综合征（CRS）可能危及生命，已成为当前关注的焦点。我院Ⅰ期临床试验1例乳腺癌患者，首次输注重组人源化双功能单克隆抗体MBS301在11 min后出现胸闷、气急渐加重、周身湿冷、血氧下降等症状，考虑为CRS。予以甲泼尼龙琥珀酸钠抗炎，哌拉西林钠舒巴坦钠及利奈唑胺抗感染、化痰等对症治疗，患者症状好转。及时应用糖皮质激素可以治疗双特异性单克隆抗体引起的CRS。

关键词 重组人源化双功能单克隆抗体 细胞因子释放综合征 糖皮质激素

中图分类号：R979.19； R965.3 文献标志码：B 文章编号：1006-1533（2021）09-0036-03

A case report of recombinant humanized bispecific monoclonal antibodyinduced cytokine release syndrome

ZHOU Yuting*， ZHU Bin， MA Yan* *

（Department of Pharmacy， Shanghai Cancer Center， Fudan University， Shanghai 200032， China）

ABSTRACT The bispecific monoclonal antibody （mAbs） has been recently becoming a hotspot in cancer immunotherapy. Meanwhile， the immune-related fatal cytokine release syndrome （CRS） triggered by bispecific mAbs may be life-threatening and has become the focus of current attention. We reported a case that a female patient with relapse and metastatic breast cancer who underwent an initial infusion of MBS301 developed such symptoms as chest distress， dyspnea， clammy body， hypoxemia and so on 11 minutes after infusion. Methylprednisolone sodium succinate， piperacillin sodium and sulbactam sodium as well as linezolid were subsequently administered and her symptoms were improved. Therefore， glucocorticoid combined with antibiotics can be timely used for the treatment of CRS caused by bispecific antibody.

KEy WORDS recombinant humanized bispecific monoclonal antibody； cytokine release syndrome； glucocorticoid

近年来，随着生物技术的迅速发展，双特异性抗体（bispecific antibody，biAb）已经成为肿瘤免疫治疗的关注热点。重组人源化双功能单克隆抗体MBS301是一种岩藻糖全敲除的双特异性抗人表皮生长因子受体-2（human epidermal growth factor receptor 2，HER-2）抗体，目前处于Ⅰ期临床试验，用于治疗HER-2阳性乳腺癌和胃癌。随着双特异性抗体临床应用经验的积累，其固有的和潜在的致命性不良反应尤其是细胞因子释放综合征（CRS）备受重视。CRS是免疫治疗中多种因素触发的全身性炎症反应。其特征是细胞因子的显著升高并且伴有以下相关症状：呼吸困难、发热、头痛、低血压、恶心、皮疹、心动过速、低氧血症。本文报道我院1例复发转移的乳腺癌患者首次使用MBS301时发生CRS的案例，以期为临床提供参考。

1 临床资料

患者，女，58岁，左乳腺癌术后（ER-，PR-，HER-2+），左胸壁复发，肺﹑淋巴结转移。……