79例替雷利珠单抗相关不良反应分析

doi:10.19803/j.1672-8629.20240261

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (10): 1148-1153.
DOI: 10.19803/j.1672-8629.20240261

79例替雷利珠单抗相关不良反应分析

汪滢¹, 黄珊¹, 沈钦勇¹, 连霞¹, 常颖¹, 江彦¹, 林兵^2#, 黄爱文^1,*

¹中国人民解放军联勤保障部队第九〇〇医院临床药学科,福建福州 350025;
²中国人民解放军联勤保障部队第九〇〇医院药剂科,福建福州 350025

收稿日期:2024-04-24 出版日期:2024-10-15 发布日期:2024-10-14
通讯作者: ^*黄爱文,女,博士,副主任药师,临床药学。E-mail: Hawen83@sina.com ^#为共同通信作者。
作者简介:汪滢,女,硕士,主管药师,临床药学与药物警戒。
基金资助:
福建省科技创新联合资金项目（2020Y9041）

Seventy-nine cases of tislelizumab-related adverse reactions

WANG Ying¹, HUANG Shan¹, SHENG Qinyong¹, LIAN Xia¹, CHANG Ying¹, JIANG Yan¹, LIN Bing^2#, HUANG Aiwen^1,*

¹Department of Clinical Pharmacy, the 900th Hospital of the Joint Logistic Support Force of Chinese PLA, Fuzhou Fujian 350025, China;
²Department of Pharmacy, the 900th Hospital of the Joint Logistic Support Force of Chinese PLA, Fuzhou Fujian 350025, China

Received:2024-04-24 Online:2024-10-15 Published:2024-10-14

摘要/Abstract

摘要： 目的分析替雷利珠单抗相关药品不良反应（ADR）的发生规律及临床表现特点,为临床安全合理使用提供参考。方法回顾性分析本院上报的79例替雷利珠单抗相关ADR报告（2020年1月1日至2024年3月31日）,对患者基本情况、药物使用情况、ADR发生时间、累及系统-器官、临床表现、严重程度、处置与转归、关联性评价等信息进行统计分析。结果 79例替雷利珠单抗相关ADR报告中,88.61%的ADR发生在替雷利珠单抗治疗1~5个周期后,累及多个系统-器官,主要表现为骨髓抑制、皮肤毒性、甲状腺功能异常、肝功能异常、肌炎、肺炎等,其中重症肌无力样综合征和过敏性休克为说明书未载明的严重ADR。经停药和对症治疗后大部分ADR逐渐好转。结论替雷利珠单抗少数严重ADR可危及生命,临床应合理使用,加强用药监护,及时对症处理,减少严重ADR的发生。

关键词: 替雷利珠单抗, 免疫检查点抑制剂, 药品不良反应, 骨髓抑制, 重症肌无力样综合征, 过敏性休克, 安全性

Abstract: Objective To analyze the regularity and clinical characteristics of adverse drug reactions (ADR) induced by tislelizumab in order to provide references for safe and rational drug use. Methods Seventy-nine reports of adverse reactions related to tislelizumab submitted by our hospital to the national ADR Monitoring System from January 1, 2020 to March 31, 2024 were retrospectively analyzed, involving patients' demographics, types of drugs used, times of adverse reactions, clinical presentations, organs and/or systems involved, severity, management and outcomes, causality assessment, and off-label use. Results Among these cases of tislelizumab-related adverse reactions, 88.61% occurred after one to five medication cycles. Affecting multiple organs and systems, the main manifestations included bone marrow suppression, skin toxicity, thyroid dysfunction, and liver function abnormalities. Myasthenic syndrome and anaphylactic shock were serious ADR not specified in drug instructions. After discontinuation of the drug and symptomatic treatment, most of the cases improved. Conclusion A few severe adverse reactions of tislelizumab can lead to life-threatening consequences. Close monitoring during clinical use is recommended, with timely symptomatic treatment to reduce severe adverse reactions.

Key words: tislelizumab, immune checkpoint inhibitors, adverse drug reaction, bone marrow suppression, myasthenic syndrome, anaphylactic shock, safety

中图分类号:

汪滢, 黄珊, 沈钦勇, 连霞, 常颖, 江彦, 林兵, 黄爱文. 79例替雷利珠单抗相关不良反应分析[J]. 中国药物警戒, 2024, 21(10): 1148-1153.

WANG Ying, HUANG Shan, SHENG Qinyong, LIAN Xia, CHANG Ying, JIANG Yan, LIN Bing, HUANG Aiwen. Seventy-nine cases of tislelizumab-related adverse reactions[J]. Chinese Journal of Pharmacovigilance, 2024, 21(10): 1148-1153.

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79例替雷利珠单抗相关不良反应分析

Seventy-nine cases of tislelizumab-related adverse reactions

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