中国药物警戒 ›› 2022, Vol. 19 ›› Issue (3): 292-295.
DOI: 10.19803/j.1672-8629.2022.03.13

• 安全与合理用药 • 上一篇    下一篇

73例临床应用卡瑞利珠单抗的安全性分析

黄灿1, 齐腊梅1, 李多慧1, 陈昭琳2,#, 居靖3,*   

  1. 1安徽医科大学附属安庆医院药事管理科,安徽 安庆 246000;
    2中国科学技术大学附属第一医院（安徽省立医院）药剂科,安徽 合肥 230001;
    3安徽医科大学附属安庆医院设备科,安徽 安庆 246000
  • 收稿日期:2021-06-07 出版日期:2022-03-15 发布日期:2022-03-16
  • 通讯作者: *居靖,男,博士,主任药师·硕导,临床药学与肿瘤药理学。E-mail：ju051205@126.com
  • 作者简介:黄灿,女,硕士,主管药师,临床药学与肿瘤药理学。#为共同通信作者。
  • 基金资助:
    国家自然科学基金资助项目（81602344）; 安徽省高校自然科学研究项目（KJ2020ZD21）

A analysis of safety of 73 users of carrelizumab

HUANG Can1, QI Lamei1, LI Duohui1, CHEN Zhaolin2,#, JU Jing3,*   

  1. 1Department of Pharmacy Management, Affiliated Anqing Hospital of Anhui Medical University, Anqing Anhui 246000, China;
    2Department of Pharmacy, the First Affiliated Hospital of University of Science and Technology of China, Hefei Anhui 230001, China;
    3Department of Equipment, Affiliated Anqing Hospital of Anhui Medical University, Anqing Anhui 246000, China
  • Received:2021-06-07 Online:2022-03-15 Published:2022-03-16

PDF (PC)

155

摘要： 目的 对卡瑞利珠单抗在肿瘤患者临床使用中的安全性进行回顾性研究,为临床合理用药提供参考。方法 收集安徽医科大学附属安庆医院2020年1月1日至12月31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（irAEs）发生情况等,评价其临床用药安全性。探讨irAEs与性别、年龄、基础疾病及肿瘤类型等因素之间的关系。结果 收集73例使用卡瑞利珠单抗的肿瘤患者,共计264次化疗。41例患者为超说明书适应证用药;39例患者发生irAEs,其中6例同时出现累及3个及以上系统的不良反应;1~2级毒性29例,3级毒性9例,4级毒性1例,主要包括内分泌毒性、皮肤及黏膜毒性和肝脏毒性等。irAEs在不同类型肿瘤中发生率不同,在肝癌中发生率最高,在肺癌中发生率最低,且差异具有统计学意义。结论 卡瑞利珠单抗在临床超适应证使用较普遍,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: 肿瘤, 卡瑞利珠单抗, 超适应证用药, 药品不良反应, 安全性

Abstract: Objective To retrospectively analyze the safety of carrelizumab in clinical use among cancer patients and to provide reference for rational use of this drug. Methods The clinical data on inpatients who had received carrilizumab in the Affiliated Anqing Hospital of Anhui Medical University between January 1 and December 31, 2020 was collected. The basic information on these patients, medications and the incidence of immune-related adverse events (irAEs) were recorded and analyzed to evaluate the safety of clinical medication. The relationships between irAEs and gender, age, preexisting diseases and cancer types were explored. Results Carrelizumab was used by seventy-three tumor patients for 264 times, and forty-one of these patients experienced off-label drug use. irAEs occurred in thirty-nine of these patients, six of whom had adverse reactions involving three or more systems. Among the cases of adverse reactions, twenty-nine were of grade 1~2 toxicity, nine of grade 3 toxicity, and one of grade 4 toxicity, including endocrine toxicity, skin and mucosal toxicity and liver toxicity. The incidence of irAEs varied according to types of tumors, being the highest with liver cancer and the lowest with lung cancer, and the difference was statistically significant. Conclusion The off-label drug use of carrelizumab is common. The incidence of irAEs is high, but symptoms are not severe. Early detection and interventions are of great importance.

Key words: tumor, carrelizumab, off-label drug use, adverse drug reactions, safety

中图分类号: