替雷利珠单抗不良反应病例报告及文献回顾

Case Reports of Adverse Drug Reactions Induced by Tislelizumab in A Hospital and the Literature Review

目的探索替雷利珠单抗导致药品不良反应(adverse drug reaction,ADR)的特点,为临床用药安全提供参考。方法回顾性分析首都医科大学附属北京友谊医院2021年7月—2022年12月使用替雷利珠单抗导致ADR的病例,检索自2019年1月至2022年12月PubMed、ScienceDirect、Embase、万方、维普数据库中替雷利珠单抗导致ADR的个案报道,对纳入病例的年龄、性别、原患疾病、ADR的发生时间、临床表现、处理及转归等进行特点分析。结果该院使用替雷利珠单抗导致ADR 8例患者,文献检索纳入22例患者,共计30例ADR,男性占比83.33%(25/30),60岁以上(21例,70.00%)占比最高,ADR多发生在1~2个用药周期内,以皮肤毒性(8例)、胃肠炎(6例)、肾损伤(4例)为主。经对症治疗后,29例患者好转,1例患者死亡。结论该药使用期间应警惕皮肤、胃肠道和肾脏的ADR,并密切监测相关指标变化。

Objective To investigate the characteristics of adverse drug reactions(ADRs)induced by tislelizumab and to provide reference for clinic drug safety.Methods The ADR of tislelizumab in Beijing Friendship Hospital Affiliated to Capital Medical Univeristy from July 2021 to December 2022 were retrospectively analyzed.The case reports of ADR induced by tislelizumab from January 2019 to December 2022 in PubMed,ScienceDirect,Embase,Wanfang,VIP databases were searched.Age,sex,original diseases,adverse reaction time,clinical manifestation,treatment measures and clinical outcome were analyzed.Results A total of 30 patients including 8 cases in hospital and 22 cases in literature were collected.Among these patients,male accounted for 83.33%(25/30),and the highest proportion was from patients over 60 years old(21 patients,70.00%).Most ADRs occurred in 1-2 dose cycles of medication,mainly including skin toxicity in 8 patients,digestive disease in 6 patients and kidney injury in 4 patients.After the symptomatic treatment,29 patients improved and 1 patient died.Conclusion During the medication with tislelizumab,ADRs of skin,gastrointestinal tract and renal should be vigilant,and the changes of relevant indicators should be closely monitored.