某三级医院79例纳武利尤单抗不良反应分析及安全性研究

Analysis of adverse reactions and safety study of 79 cases of nivolumab in a tertiary hospital

目的:分析临床使用纳武利尤单抗发生药品不良反应(ADR)的临床特点,为用药安全提供参考。方法:采用回顾性研究方法,收集某医院2018年1月-2022年1月发生纳武利尤单抗相关ADR的患者信息,对患者一般信息、基础疾病、用药剂量、联合用药、ADR累及系统/器官、ADR分级、临床转归等进行统计分析。结果:共涉及79例患者,男性52例(65.82%),女性27例(34.18%),年龄主要集中在50~69岁(58.23%);基础疾病以肺癌最为常见(22例,27.85%),其次为肝癌(18例,22.78%)和胃癌(18例,22.78%);79例患者共发生ADR 107例次,1~2级ADR 100例次(93.46%)、3~4级ADR 7例次(6.54%);ADR主要累及系统/器官为皮肤及其附件(27例次,25.23%)、肝胆系统(17例次,15.89%)、内分泌系统(15例次,14.02%)等;经停药和(或)对症治疗后好转或痊愈75例,死亡4例。结论:临床使用纳武利尤单抗时应评估患者的风险与收益,加强用药安全性监测,警惕ADR的发生。

Objective:To analyze the clinical characteristics of adverse drug reaction(ADR)induced by nivolumab,and provide references for safety drug use.Methods:Patients with ADR induced by nivolumab in a hospital from January 2018 to January 2022 were retrospectively collected and analyzed in terms of the general information,basic diseases,drug dosage,drug combination,systems/organs involved in ADR,ADR classification,and clinical outcomes,etc.Results:A total of 79 patients were involved including 52 males(65.82%)and 27 females(34.18%),mainly aged 50-69 years old(58.23%).Lung cancer was the most common underlying disease(22 cases,27.85%),followed by liver cancer(18 cases,22.78%)and gastric cancer(18 cases,22.78%).A total of ADR 107 times occurred in 79 patients,including grade 1 to 2 ADR 100 times(93.46%)and grade 3 to 4 ADR 7 times(6.54%).The mainly systems/organs involved in ADR were skin and its accessories(27 times,25.23%),hepatobiliary system(17 times,15.89%)and endocrine system(15 times,14.02%).After drug withdrawal and/or symptomatic treatment,75 cases improved or recovered and 4 cases died.Conclusion:It was suggested to pay more attentions to the safety of nivolumab including evaluating the risks and benefits of patients,strengthening monitoring and being alert to ADR induced by nivolulmab.