信迪利单抗致药品不良反应文献分析

Literature analysis of adverse drug reaction induced by sintilimab

目的:探讨信迪利单抗所致药品不良反应(ADR)的发生规律及特点,为临床安全用药提供参考。方法:检索2018年12月-2022年6月中国知网、万方、维普、PubMed数据库中关于信迪利单抗致ADR的个案报道,对数据进行整理分析。结果:共收集49篇符合条件的文献,51例信迪利单抗致ADR的个案报道,男女患者比例为2∶1,≤65岁的患者较多(62.75%);ADR多发生在给药的第1个周期(37.25%);ADR主要累及内分泌系统(31.81%)、皮肤及其附件(15.15%)、消化系统(15.15%)和呼吸系统(10.60%)等。结论:信迪利单抗所致ADR累及多个系统/器官,潜伏周期长,临床使用时应进行全程用药监测,尤其需关注首次用药的患者,确保用药安全。

Objective:To explore the occurrence and characteristics of adverse drug reaction(ADR)induced by sintilimab,and provide references for safety drug use in clinic.Methods:Case reports of ADR induced by sintilimab were collected and analyzed from databases including CNKI,Wanfang,VIP and PubMed from December 2018 to June 2022.Results:A total of 51 case reports of ADR induced by sintilimab were collected from 49 qualified literature,in which the male to female ratio was 2 to 1 and 62.75%of the patients aged equal or below 65 years old.37.25%of ADRs occurred within the first cycle of the treatment.ADRs mainly involved the endocrine system(31.81%),skin and its accessories(15.15%),digestive system(15.15%)and respiratory system(10.60%),etc.Conclusion:ADRs induced by sintilimab involved multiple systems/organs with a long incubation period.It was suggested to carry out the whole-course pharmaceutical care during the course of treatment and pay more attentions to patients who take sintilimab for the first time to ensure the drug safety.