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纳武利尤单抗药品不良反应文献分析

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目的 为及时识别与处理纳武利尤单抗所致药品不良反应(ADR)提供参考。方法 检索PubMed、中国知网、万方、维普数据库中有关纳武利尤单抗ADR的个案报道,检索时限为各数据库自建库起至 2021 年 12 月。汇总分析出现ADR患者的临床信息(包括患者的一般情况、原患疾病,纳武利尤单抗使用剂量,ADR出现时间、累及系统/器官、临床表现、最终结局等)。结果 共纳入文献 600 篇,涉及患者 649 例(发生ADR 679 例次),其中男 444 例(68。41%),女 205 例(31。59%);患者年龄(63。41±12。63)岁;涉及原患疾病以非小细胞肺癌最多(219 例、33。74%),其次为黑色素瘤(203 例、31。28%)。纳武利尤单抗单药治疗 505 例(77。81%),用量高于或低于药品说明书要求的分别有 4例和 59例;联合用药 144例(22。19%)。ADR主要发生在用药后 6个月内,主要累及内分泌系统(105例次)、神经系统(95 例次)、皮肤及其附件(84 例次)等。临床症状自行缓解 8 例次(1。18%),对症处理后改善 576 例次(84。83%),发生致死性ADR 72 例次(10。60%,主要累及心血管系统、神经系统、肌肉骨骼系统等)。结论 纳武利尤单抗ADR发生以男性、60~79 岁患者居多,多发生在用药后 6 个月内。其ADR累及多个系统,多数程度较轻,经临床治疗后可改善,但应特别注意心肌炎、重症肌无力、肌炎、移植排斥反应、免疫相关性肺炎等ADR,防止发生致死性ADR。
Literature Analysis of Adverse Drug Reactions Induced by Nivolumab
Objective To provide a reference for timely identification and response of adverse drug reactions(ADRs)induced by nivolumab.Methods The case reports of ADRs induced by nivolumab in the PubMed,CNKI,WanFang and VIP from the inception of these databases to December 2021 were searched.The clinical information on patients with ADRs(including patients′ general data,primary disease,dosage of nivolumab,occurrence time of ADRs,involved systems/organs,clinical manifestations,final outcomes)was summarized and analyzed.Results A total of 600 studies were included,involving 649 patients(679 case times of ADRs),including 444 males(68.41%)and 205 females(31.59%),with the mean age of(63.41±12.63)years.The primary disease of patients was mainly non-small cell lung cancer(219 cases,33.74%),followed by melanoma(203 cases,31.28%).A total of 505 cases(77.81%)were treated with nivolumab monotherapy,with four and 59 cases receiving the higher and lower dosages than requirements of the drug instructions respectively,and 144 cases(22.19%)were treated with nivolumab combined with other drugs.ADRs mainly occurred within six months after medication,mainly involving the endocrine system(105 case times),nervous system(95 case times),skin and its appendages(84 case times).Eight case times of ADRs(1.18%)showed the clinical symptoms that relieved spontaneously,576 case times(84.83%)showed improved clinical symptoms after symptomatic treatment,72 case times were fatal(10.60%,mainly involving the cardiovascular system,neural system,musculoskeletal system).Conclusion Males and patients aged 60 to 79 years are more likely to suffer from ADRs after using nivolumab,and most of ADRs occur within six months after medication.The ADRs involve many systems and are mostly mild,which can improved after clinical treatment.However,myocarditis,myasthenia gravis,myositis,transplantation rejection and immune-associated pneumonia should be paid more attention to prevent fatal ADRs.

nivolumabadverse drug reactionliterature analysisprogrammed death-1 inhibitor

赵士清、杨双宁、郭青

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北京语言大学医院,北京 100083

郑州大学第一附属医院,河南 郑州 450000

纳武利尤单抗 药品不良反应 文献分析 程序性死亡受体-1抑制剂

北京语言大学校级项目

22YJXZ0002

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(12)