120例肝癌患者使用替雷利珠单抗致免疫相关不良事件分析

doi:10.19803/j.1672-8629.20240987

摘要/Abstract

摘要： 目的分析肝癌患者使用替雷利珠单抗致免疫相关不良事件（irAEs）的特点,为临床安全用药提供参考。方法分析广西壮族自治区2022年2月1日至2024年6月30日收集并报告的肝癌患者使用替雷利珠单抗致irAEs病例的患者性别、年龄分布、用药指征、合并用药情况、临床表现、毒性分级、处理措施及转归情况,总结irAEs的规律和特点。结果共收集120例irAEs,男性患者数量为女性的4倍,45~64岁中年期患者居多,irAEs类别主要为血液系统、肝脏系统、皮肤系统等。≥G3级的irAEs 61例（50.83%）,未出现致死亡的G5级irAEs。发生irAEs后,经对症治疗后,78例（65%）的患者好转或痊愈。结论替雷利珠单抗致irAEs虽累及多个系统-器官,但经及时治疗,大多数患者的转归情况较好。临床应对其重点监测,尽早发现irAEs并采取干预措施,以防严重irAEs危及患者生命健康。

Abstract: Objective To analyze the characteristics of immune-related adverse events (irAEs) of tislelizumab in patients with hepatocellular carcinoma and provide data for safe clinical use of the drug. Methods The irAEs caused by tislelizumab in the treatment of patients with liver cancer in Guangxi Zhuang Autonomous Region from February 2022 to June 2024 were collected. The data on gender of the patients, age distribution, indications for use, concomitant medications, clinical manifestations, toxicity grading, treatments, outcomes, and the characteristics of irAEs was statistically analyzed. Results A total of 120 cases of irAEs were collected. There were four times as many male patients as female ones, and most of the patients ranged from 45 to 64 in age. The systems and organs involved in irAEs were mostly the blood system, liver system and the skin system. There were 61 cases (50.83%) of irAEs ≥G3, but no death due to G5 irAEs occurred. Seventy-eight patients (65%) showed improvement or recovery after symptomatic treatment. Conclusion Although irAEs caused by tislelizumab involve multiple systems and organs, most patients have good outcomes if treated promptly. During clinical use of tislelizumab, irAEs should be detected as early as possible, and precautions have to be taken to ensure the safety and health of patients.

Key words: Tislelizumab, Immune-related Adverse Events, Hepatocellular Carcinoma, Immune Checkpoint Inhibitors, Blood System, Liver System, Skin System

中图分类号:

梁方林, 陈玲园, 胡丹荔, 韦玲云, 韦铁猛, 张发恩, 韦亚娜. 120例肝癌患者使用替雷利珠单抗致免疫相关不良事件分析[J]. 中国药物警戒, 2025, 22(6): 659-663.

LIANG Fanglin, CHEN Lingyuan, HU Danli, WEI Lingyun, WEI Tiemeng, ZHANG Faen, WEI Yana. Immune-Related Adverse Events of Tislelizumab in 120 Patients with Hepatocellular Carcinoma[J]. Chinese Journal of Pharmacovigilance, 2025, 22(6): 659-663.

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