中国药物警戒 ›› 2026, Vol. 23 ›› Issue (3): 307-311.
DOI: 10.19803/j.1672-8629.20250439

• 安全与合理用药 • 上一篇    下一篇

注射用卡瑞利珠单抗致严重不良反应及风险因素分析

蒋艳林1, 邓俊刚1, 陈薇1, 张晶晶1, 方春霞1, 覃忠于2, 彭英知2, 郭冰1, 廖儒佳1,*   

  1. 1桂林医科大学第一附属医院药学部,广西 桂林 541001;
    2广西壮族自治区药品不良反应监测中心,广西 南宁 530029
  • 收稿日期:2025-07-04 出版日期:2026-03-15 发布日期:2026-03-17
  • 通讯作者: *廖儒佳,男,博士,副教授,药理学与临床药学。E-mail: liaorujia@hotmail.com
  • 作者简介:蒋艳林,女,主管药师,临床药学。
  • 基金资助:
    广西药品安全科研项目（桂药监科直属〔2023〕008 号）; 广西卫生健康委自筹经费科研课题（Z-C20240863）

Serious Adverse Reactions and Risks Caused by Camrelizumab for Injection

JIANG Yanlin1, DENG Jungang1, CHEN Wei1, ZHANG Jingjing1, FANG Chunxia1, QIN Zhongyu2, PENG Yingzhi2, GUO Bing1, LIAO Rujia1,*   

  1. 1Department of Pharmacy, the First Affiliated Hospital of Guilin Medical University, Guilin Guangxi 541001, China;
    2Guangxi Zhuang Autonomous Region Adverse Drug Reaction Monitoring Center, Nanning Guangxi 530029, China
  • Received:2025-07-04 Online:2026-03-15 Published:2026-03-17

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摘要： 目的 基于真实世界数据分析注射用卡瑞利珠单抗不良反应发生的特点及影响因素,为合理用药提供参考。方法 收集广西壮族自治区2021年5月1日至2025年3月31日上报至中国医院药物警戒系统中使用注射用卡瑞利珠单抗的肿瘤患者发生不良反应的住院病例,统计并分析患者基本信息、用药信息及不良事件发生严重程度等。结果 共纳入481例患者,严重不良反应占64.03%,男性患者高发,中老年患者比例突出,原患疾病主要为食管癌、肝癌及肺癌,累及系统-器官中血液及淋巴系统损害最常见,不良反应主要为骨髓抑制综合征、皮肤毛细血管增生、肝毒性三联征等。单因素分析显示年龄、治疗方案等存在显著差异,多因素Logistic回归分析显示年龄、治疗方案等是严重不良反应的独立危险因素,单因素ANOVA进一步提示食管癌、肝癌和鼻咽癌患者严重反应风险显著增高。结论 临床应用卡瑞利珠单抗时,应关注患者的年龄、治疗方案、肿瘤类型等,必要时进行用药监护,保障患者的用药安全。

关键词: 卡瑞利珠单抗, 食管癌, 肝癌, 肺癌, 药品不良反应, 骨髓抑制综合征, 皮肤毛细血管增生, 肝毒性

Abstract: Objective To retrospectively analyze real-world data on adverse drug reactions (ADR) associated with camrelizumab, characterize the profile, and identify contributors in order to provide evidence for rational drug use. Methods Reports about adverse reactions from hospitalized cancer patients treated with camrelizumab for injection between May 2021 and March 2025 in Guangxi Zhuang Autonomous Region were retrieved from the China Hospital Pharmacovigilance System. The demographics of patients, medications, and severity of ADR were statistically analyzed. Results Among the 481 camrelizumab-treated patients, Serious ADR accounted for over half of the reported cases. ADR were much more prevalent in males than in females. The proportion of middle-aged and elderly patients was relatively large. Primary malignancies were predominantly esophageal cancer, hepatocellular carcinoma and lung cancer. ADR primarily involved the hematopoietic/lymphatic systems, with such major manifestations as myelosuppression syndrome, reactive cutaneous capillary endothelial proliferation, and hepatotoxicity. Univariate analysis disclosed significant differences in age and treatments. Multivariate logistic regression confirmed age and combination therapy as independent risk factors for serious ADR. One-way ANOVA pointed to significantly higher proportions of serious ADR in patients with esophageal cancer, hepatocellular carcinoma, and nasopharyngeal carcinoma. Conclusion Clinical use of camrelizumab requires heightened vigilance regarding the patients’ age, treatment regimens (particularly combination chemotherapy), and specific tumor types (esophageal, hepatic, nasopharyngeal). Drugs should be monitored when necessary to ensure the safety of medication.

Key words: Camrelizumab, Esophageal Cancer, Hepatocellular Carcinoma, Lung Cancer, Adverse Drug Reactions, Myelosuppression Syndrome, Reactive Cutaneous Capillary Endothelial Proliferation, Hepatotoxicity

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