中国药物警戒 ›› 2023, Vol. 20 ›› Issue (10): 1134-1140.
DOI: 10.19803/j.1672-8629.20230011

• 安全与合理用药 • 上一篇    下一篇

528例卡瑞利珠单抗治疗的免疫相关不良反应及风险因素分析

余敏1,2, 李歆2,3,*   

  1. 1南京医科大学第一附属医院药学部,江苏 南京 210029;
    2南京医科大学药学院,江苏 南京 211166;
    3南京医科大学全球健康中心,江苏 南京 211166
  • 收稿日期:2023-01-05 出版日期:2023-10-15 发布日期:2023-10-16
  • 通讯作者: *李歆,男,博士,教授·博导,临床药学与药物经济学。E-mail：xinli@njmu.edu.cn
  • 作者简介:余敏,女,硕士,主管药师,临床药学。
  • 基金资助:
    国家自然科学基金资助项目（72074123）

Immunerelated adverse events and risk factors of carrelizumab in 528 cases of cancer patients

YU Min1,2, LI Xin2,3,*   

  1. 1Department of Pharmacy, the First Affiliated Hospital with Nanjing Medical University, Nanjing Jiangsu 210029, China;
    2School of Pharmacy, Nanjing Medical University, Nanjing Jiangsu 211166, China;
    3Center for Global Health, School of Public Health, Nanjing Jiangsu Medical University, Nanjing Jiangsu 211166, China
  • Received:2023-01-05 Online:2023-10-15 Published:2023-10-16

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摘要： 目的 对卡瑞利珠单抗在肿瘤患者免疫治疗中安全性进行回顾性研究,并分析其免疫相关不良事件（immune-related adverse events, irAEs）的影响因素,为临床安全用药提供参考。方法 收集南京医科大学第一附属医院2021年7月1日至2022年6月30日使用卡瑞利珠单抗的肿瘤患者住院病例,统计并分析患者基本信息、用药信息及免疫相关不良事件发生情况等,评价其临床用药安全性,并探讨 irAEs 发生的影响因素。结果 收集528例使用卡瑞利珠单抗的患者,其中184例（34.85%）患者发生218例次irAEs,累及系统-器官10种,发生率最高的分别是内分泌系统132例次（60.55%）,皮肤和皮下组织50例次（22.94%）。大部分irAEs为G1~G2级,其中G1级 117例次（53.67%）,G2级86例次（39.45%）, G3级12例次（5.50%）,经对症治疗后可以好转,未出现致死性不良事件,其他级别3例次（1.37%）。基础疾病乙肝、肿瘤类型、治疗方案、免疫检查点抑制剂(immune checkpoint inhibitors, ICIs)治疗周期是卡瑞利珠单抗发生irAEs的单危险因素,具有统计学意义（P<0.05）;对多危险因素进行二项Logistic回归分析,仅有治疗方案与ICIs治疗周期具有统计学意义（P<0.05）。在卡瑞利珠单抗致反应性皮肤毛细血管增生症(reactive cutaneous capillary endothelial proliferation, RCCEP)的影响因素中联合使用抗血管生成药物具有统计学意义（P<0.05）。结论 卡瑞利珠单抗在肿瘤中使用广泛,irAEs 发生较多,但程度较轻,且在不同肿瘤中发生率不同,及时发现、早期干预非常重要。

关键词: 卡瑞利珠单抗, 肿瘤, 免疫检查点抑制剂, 免疫相关不良事件, 免疫, 不良反应, 风险因素

Abstract: Objective To retrospectively analyze immunerelated adverse events and risk factors of carrelizumab among cancer patients, and provide reference for its clinical applications. Methods The clinical data of patients treated with carrilizumab was collected from Jiangsu Province Hospital between July 1, 2021 and June 30, 2022. The safety of clinical medication was assessed by analyzing the clinical pathological features and the incidence of immune-related adverse events (irAEs) among patients with carrilizumab administration. The correlations between irAEs and clinical pathological features were explored. Results Oner hundred and eighty-four out of a total of 528 patients (34.85%) experienced irAEs involving dysfunction of 10 organ systems. The most common adverse reactions were observed in the endocrine system and the skin and soft tissue system. No fatal adverse events were observed. Most of the irAEs were G1~G2 grade, including 117 cases (53.67%) of G1 grade, 86 cases (39.45%) of G2 grade, 12 cases (5.50%) of G3 grade and 3 cases (1.37%) of other grades. The risk factors for irAEs of carrelizumab were identified as hepatitis B infection, tumor type, treatment schemes and the courses of treatment with immune checkpoint inhibitors ICIs (P<0.05). Multivariate analysis suggested that significant factors related to irAEs were the treatment schemes and coursed of treatment (P<0.05). In addition, reactive cutaneous capillary endothelial proliferation RCCEP related to incarrellizumab administration was statistically related to the co-administration of antiangiogenic drugs by multivariate analysis (P<0.05). Conclusion The symptoms of irAEs related to carrilizumab administration are moderate despite the high incidence. Early detection and interventions are of great importance for these patients.

Key words: carrelizumab, tumor, immune checkpoint inhibitors, ICIs, immune-related adverse events, irAEs, immunerelated, adverse drug reaction, risk factors

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