1例信迪利单抗注射液导致严重皮肤免疫毒性的病例及文献回顾分析  

Sintilimab Injection-Induced Severe Cutaneous Immunotoxicity:A Case Report and Review of the Literature

作　　者：田雪梅 卢立山[1] 李俊义[1] 史存发 罗昆[1] 刘敏[1] 殷波 TIAN Xue-mei;LU Li-shan;LI Jun-yi;SHI Cun-fa;LUO Kun;LIU Min;YIN Bo(Pharmaceutical Preparation Section,Ordos Central Hospital,Ordos 017020,China)

机构地区：[1]鄂尔多斯市中心医院药剂科,鄂尔多斯017020

出　　处：《中国合理用药探索》2022年第9期94-101,共8页Chinese Journal of Rational Drug Use

基　　金：内蒙古自治区自然科学基金面上项目(2020MS08177)。

摘　　要：目的:通过1例使用信迪利单抗注射液导致严重皮肤免疫相关性毒性反应的病例分析,总结分析程序性死亡蛋白1/程序性死亡分子配体1(PD-1/PD-L1)抑制剂相关皮肤毒性,为临床合理用药提供参考。方法:跟踪随访患者治疗经过,同时检索中国知网、万方数据库、维普数据库、UpToDate、PubMed关于信迪利单抗皮肤免疫相关不良反应(irAE)的相关文献并进行统计分析。结果:本例患者使用信迪利单抗注射液治疗1个月出现皮疹,未重视,皮疹逐渐加重,入院后经过激素治疗逐渐好转。通过文献检索信迪利单抗所致皮肤irAE共8例,男性患者(6/8,75%)多于女性;皮肤相关ADR多发生于用药后4周期内;有6例经过激素对症治疗,1例抗组胺类药物治疗,1例未采取治疗措施。结论:irAE发生率较低且多为轻中度,具有可逆性,但严重者可致死。因此,医生和临床药师应重视irAE、风险因素、特殊人群的识别、治疗药物不良反应监测,同时积极参与随访,降低肿瘤患者的不良反应风险,延长生存期。Objective:To analyze the skin toxicity related to programmed cell death 1/programmed cell death ligand 1(PD-1/PD-L1)inhibitor by a case of severe skin immune-related toxicity caused by sintilimab injection,and to provide references for clinical rational drug use.Methods:The treatment process of patients were tracked and followed up.At the same time,the relevant literature on skin-related immune-related adverse reactions(irAE)of sindilizumab injection was retrieved from CNKI,Wanfang,VIP database,UpToDate and PubMed database for statistics and analysis.Results:In this case,the patient developed rash after 1 month of treatment with sindilizumab injection,which was not paid attention to,and the rash gradually worsened.After admission,the patient gradually improved after hormone treatment.A total of 8 cases of skin irAE caused by sindilizumab injection were retrieved from the literature,male patients were significantly more than female patients(6/8,75%).Skin-related irAE mostly occurred within 4 cycles after medication.Six cases were treated with hormone,1 case with antihistamines,and 1 case without treatment.Conclusion:The incidence of adverse reactions in immunotherapy is low and mostly mild to moderate,which is reversible,but in severe cases it can lead to death.Therefore,physicians and clinical pharmacists should pay more attention to patients and pay more attention to the identification of immune-related adverse reactions,risk factors,identification of special populations,and monitoring of therapeutic adverse reactions.Meanwhile,they should actively participate in follow-up to reduce the prognostic risk of adverse reactions in tumor patients and prolong their survival.

关 键 词：信迪利单抗注射液 PD-1/PD-L1抑制剂 病例报道 免疫相关不良反应 文献分析 皮肤毒性 

分 类 号：R969.3[医药卫生—药理学]