国产PD-1抗体药物信迪利单抗上市后的药品不良反应回顾性分析  

A Retrospective Analysis of Post-Marketing Adverse Drug Reactions of Sindilizumab Domestic PD-1 Antibody Drug

作　　者：刘红[1] 白羽[1] 王啸洋 张艳华[1] 付娜[2] LIU Hong;BAI Yu;WANG Xiaoyang;ZHANG Yanhua;FU Na(MOE Key Laboratory of Carcinogenesis and Translational Research,Department of Pharmacy,Peking University Cancer Hospital&Institute,Beijing 100142,China;Beijing Center for ADR Monitoring,Beijing 101117,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所药剂科,恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [2]北京市药品不良反应监测中心,北京101117

出　　处：《中国药学杂志》2024年第18期1748-1756,共9页Chinese Pharmaceutical Journal

摘　　要：目的现有关于信迪利单抗不良反应(adverse drug reactions,ADRs)的研究多为个案报告和文献汇总,缺乏对上市后人群ADRs的真实世界数据进行评估和分析。本研究致力于填补这一研究空白,以便为临床上的安全用药提供重要的参考依据。方法数据来源为北京市药品不良反应监测系统数据库,涵盖了北京地区截至2023年近五年涉及信迪利单抗的ADRs报告。这些报告以信迪力单抗为怀疑药品上报。通过SPSS 22.0软件对数据进行统计分析。结果本研究共分析了155例信迪利单抗相关的ADRs报告。在性别分布上,男性患者与女性患者的比例为1.77∶1。在ADRs报告中,以皮肤反应最为常见。在24 h内发生的ADRs报告中,过敏反应占主导。严重ADRs的报告占比达到26.45%,且这些严重反应多在用药24 h后发生,差异具有统计学意义(P=0.005)。非适应证肿瘤患者用药后发生严重ADRs的风险要明显高于适应证患者(P=0.006)。9例患者药物剂量超出说明书推荐剂量导致ADRs。与仑伐替尼联合用药时,可引起心肌梗死和糖尿病酮症酸中毒,属新的安全性信号,在临床使用时应予以关注。结论本研究发现非适应证人群用药后发生严重ADRs的风险增加,因此对于非适应证给药患者需更加严密监测患者用药后的反应,以及时进行干预。严重ADRs多发生于24 h后,在日间24 h治疗的患者,出院后需嘱咐患者密切监测用药后情况,如有不适需及时就诊。临床存在未按说明书推荐剂量用药情况,应予以关注。与仑伐替尼合用时,可引起心肌梗死和糖尿病酮酸中毒,属新的安全性信号,需临床密切关注。OBJECTIVE To evaluate and analyze real-world post-marketing adverse drug reactions(ADRs)of sindilizumab and provide critical reference for safe clinical medication.METHODS The data were sourced from the National Adverse Drug Reaction Monitoring System database,covering ADR reports related to sindilizumab in Beijing area in the past five years.These reports identified sindilizumab as the suspected drug to the ADRs.Statistical analysis was conducted using SPSS 22.0 software.RESULTS A total of 155 sindilizumab-related ADR reports were analyzed.In terms of gender distribution,the ratio of male to female patients was 1.77∶1.Skin reactions were the most common ADRs reported.Allergic reactions dominated ADR reports occurring within 24 hours.Severe ADRs accounted for 26.45%of the reports,with most severe reactions occurring after 24 hours of medication use(P=0.005).In patients with tumors not included in the approved indications,the risk of experiencing severe ADRs was significantly higher compared with those with indicated conditions(P=0.006).Nine patients experienced ADRs due to drug dosages exceeding the recommended dosage in the instructions.Additionally,the concomitant use of the drug with lenvatinib was associated with the emergence of new safety signals,including myocardial infarction and diabetic ketoacidosis,necessitating heightened vigilance in clinical practice.CONCLUSION This investigation has uncovered an augmented risk of severe ADRs in individuals receiving medications for non-indicated uses.Consequently,implementation of stricter surveillance measures is needed for patients with off-label conditions to facilitate timely medical interventions.Notably,a significant incidence of severe ADRs is observed to occur beyond the initial 24-hour period following treatment.Thus,individuals receiving the drug in day-care unit should be explicitly instructed to closely monitor their post-medication health status upon discharge and to seek immediate medical consultation in case of any arising discomfort.There exists n

关 键 词：信迪利单抗 药物警戒 药品不良反应 药物监测 合理用药 

分 类 号：R979[医药卫生—药品]