注射用芦康沙妥珠单抗致序贯性超敏反应1例分析

doi:10.19803/j.1672-8629.20250854

中国药物警戒 ›› 2026, Vol. 23 ›› Issue (8): 938-940.
DOI: 10.19803/j.1672-8629.20250854

注射用芦康沙妥珠单抗致序贯性超敏反应1例分析

谢华丽^1,2, 关碧茜³, 卓羽波¹, 何洁丽¹, 陈喆^2,*

¹香港大学深圳医院药学部,广东深圳 518000;
²国家癌症中心,国家肿瘤临床医学研究中心,中国医学科学院北京协和医学院肿瘤医院药剂科,北京 100021;
³香港大学深圳医院临床肿瘤中心,广东深圳 518000

收稿日期:2025-12-01 出版日期:2026-08-15 发布日期:2026-08-17
通讯作者: ^*陈喆,女,硕士,副主任药师,临床药学。E-mail: gigichen79@126.com
作者简介:谢华丽,女,本科,主管药师,临床药学。

One case of sequential delayed-to-immediate hypersensitivity reaction caused by sacituzumab tirumotecan for injection

Xie Huali^1,2, Guan Bixi³, Zhuo Yubo¹, He Jieli¹, Chen Zhe^2,*

¹Department of Pharmacy, the University of Hong Kong-Shenzhen Hospital, Shenzhen Guangdong 518000, China;
²Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China;
³Clinical Oncology Medical Center, the University of Hong Kong-Shenzhen Hospital, Shenzhen Guangdong 518000, China

Received:2025-12-01 Online:2026-08-15 Published:2026-08-17

摘要/Abstract

摘要： 目的分析注射用芦康沙妥珠单抗（Sacituzumab Tirumotecan for Injection, sac-TMT）诱发序贯性超敏反应（Hypersensitivity Reactions, HSRs）病例,为安全用药提供参考。方法分析1例晚期乳腺癌患者接受sac-TMT治疗后发生的序贯性HSRs,结合文献分析其临床表现、实验室检查结果及治疗。结果患者首次用药后第4天出现迟发型皮疹、瘙痒伴发热（Ⅳ型HSRs）,第2次用药后13 min发生过敏性休克（Brown 3级,Ⅰ型HSRs）。实验室检查显示总免疫球蛋白E（IgE）及白介素-6（IL-6）升高,因果关系评定为“很可能”。经停药及抢救后,患者恢复并永久停用该药。结论 sac-TMT可诱发由Ⅳ型向再暴露后Ⅰ型HSRs演变的序贯性反应,提示免疫原性风险。对存在HSRs危险因素或既往有HSRs史患者,用药前应充分评估、做好抢救准备,严格遵循指南与说明书规范管理。

关键词: 注射用芦康沙妥珠单抗, Ⅳ型超敏反应, Ⅰ型超敏反应, 序贯性反应, 药品不良反应

Abstract: Objective To analyze one case of sequential hypersensitivity reactions (HSRs) caused by sacituzumab tirumotecan for injection (sac-TMT) and provide a reference for safe clinical use. Methods One case of sequential HSRs in a patient with advanced breast cancer treated with sac-TMT was analyzed. Clinical manifestations, laboratory findings, and treatment regimens were analyzed with reference to literature. Results Delayed rash, pruritus, and fever occurred 4 days after the first dose, which was consistent with type Ⅳ HSR. During the second infusion, anaphylactic shock (typeⅠHSR) occurred 13 minutes after initiation and was classified as Brown grade 3. Total immunoglobulin E and interleukin-6 levels were elevated. Causality was determined as “probable”. After drug withdrawal and emergency treatment, the patient recovered. Sac-TMT was permanently discontinued. Conclusion Sac-TMT can induce sequential HSRs progressing from typeⅣ to typeⅠupon re-exposure, suggesting immunogenicity risks. For patients with risk factors for HSRs or a history of HSRs, comprehensive pre-treatment assessment and emergency preparedness are recommended in accordance with clinical guidelines and prescribing information.

Key words: Sacituzumab Tirumotecan for Injection, TypeⅣ Hypersensitivity Reaction, TypeⅠHypersensitivity Reaction, Sequential Reaction, Adverse Drug Reaction

中图分类号:

谢华丽, 关碧茜, 卓羽波, 何洁丽, 陈喆. 注射用芦康沙妥珠单抗致序贯性超敏反应1例分析[J]. 中国药物警戒, 2026, 23(8): 938-940.

Xie Huali, Guan Bixi, Zhuo Yubo, He Jieli, Chen Zhe. One case of sequential delayed-to-immediate hypersensitivity reaction caused by sacituzumab tirumotecan for injection[J]. Chinese Journal of Pharmacovigilance, 2026, 23(8): 938-940.

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注射用芦康沙妥珠单抗致序贯性超敏反应1例分析

One case of sequential delayed-to-immediate hypersensitivity reaction caused by sacituzumab tirumotecan for injection

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