替雷利珠单抗致患者严重免疫相关性不良事件的文献分析  

Literature Analysis of Serious Immune-related Adverse Events Caused by Tislelizumab in Patients

作　　者：石金芳[1] 蒋玲[1] SHI Jin-fang;JIANG Ling(The First Affiliated Hospital of Soochow University,Suzhou Jiangsu 215006,China)

机构地区：[1]苏州大学附属第一医院,江苏苏州215006

出　　处：《抗感染药学》2023年第8期805-809,共5页Anti-infection Pharmacy

摘　　要：目的:分析替雷利珠单抗(BGB-A317)致患者发生史蒂文斯-约翰逊综合征(Stevens-Johnson syndrome,SJS)、中毒性表皮坏死溶解症(toxic epidermal necrolysis,TEN)等严重免疫相关性不良事件(immune-related adverse events,irAEs)的临床特点,为临床BGB-A317的安全、合理使用提供参考。方法:以“替雷利珠单抗(tislelizumab)”“蒂文斯-约翰逊综合征(Stevens-Johnson syndrome)“”中毒性表皮坏死溶解症(toxic epidermal necrolysis)“”药物不良反应(adverse drug reaction)“”免疫相关性不良事件(immune-related adverse events)“”案例报道(case report)”等中英文检索词,在Embase、PubMed、中国知网和中国生物医学文献服务系统等国内外数据库中检索截至2022年11月的有关BGB-A317致SJS/TEN的案例报道文献,分析BGB-A317致SJS/TEN的临床特点。结果:在相关数据库中共检索到5篇质量较高的案例报道文献,涉及病例5例,其中致TEN的有4例,致SJS的有1例;5例患者(男3例,女2例)年龄为55~93岁,其BGB-A317的用法用量均为“200 mg,q3w”,其发生SJS/TEN距离第一次使用BGBA317的时间为54~127 d(中位数值为63 d);5例患者中,BGB-A317致SJS/TEN的皮肤毒性反应表现为黏膜受累(均为口腔黏膜)和前驱性皮疹;其中,发生SJS的患者同时出现黏膜受累和前驱性皮疹;而4例发生TEN的患者中有1例未出现皮肤毒性反应,其余3例均出现前驱性皮疹,但出现黏膜受累的仅有1例;5例发生SJS/TEN的患者经对症治疗后均好转或痊愈。结论:癌症患者在使用BGB-A317治疗过程中发生SJS/TEN等irAEs是需要受到高度关注的,一旦出现黏膜受累或前驱性皮疹等表现时,临床应积极排查和诊断,确保患者的用药安全。Objective:To analyze the clinical characteristics of serious immune-related adverse events(irAEs)such as Stevens-Johnson syndrome(SJS)and toxic epidermal necrolysis(TEN)occurring in patients caused by tislelizumab(BGB-A317),and provide reference for the safe and rational use of BGB-A317.Methods:The case reports and literature related to SJS/TEN caused by BGB-A317 as of November 2022 were searched from domestic and foreign databases such as Embase,PubMed,CNKI,SinoMed using"tislelizumab","Stevens-Johnson syndrome","toxic epidermal necrolysis","adverse drug reaction","immune-related adverse events"and"case report"as the search terms,to analyze the clinical characteristics of SJS/TEN caused by BGB-A317.Results:Five high-quality case reports were searched from relevant databases,involving 5 medical cases,including 4 TEN cases and 1 SJS case;5 patients(3 males and 2 females)were aged from 55 to 93 years,and the dosage and administration of BGB-A317 was"200 mg,q3w".The period from the first use of BGB-A317 to the onset of SJS/TEN was 54 to 127 days(median:63 days).Among the 5 patients,the skin toxic reactions of SJS/TEN caused by BGB-A317 were manifested as mucosal involvement(all oral mucosa)and prodromal rash;among them,patients who developed SJS had mucosal involvement and prodromal rash;while 1 of the 4 patients who developed TEN had no skin toxic reaction and 3 of them developed prodromal rash,but only 1 patient had mucosal involvement.All of the 5 patients who developed SJS/TEN improved or recovered after symptomatic treatment.Conclusion:The irAEs such as SJS/TEN occurring in cancer patients during treatment with BGB-A317 shall be highly concerned;once manifestations such as mucosal involvement or prodromal rash have occurred,clinical investigation and diagnosis shall be performed actively to ensure the medication safety of patients.

关 键 词：替雷利珠单抗 免疫相关性不良事件 史蒂文斯-约翰逊综合征 中毒性表皮坏死溶解症 文献分析 

分 类 号：R969[医药卫生—药理学]