摘要
目的利用真实世界中的医药大数据,挖掘肿瘤免疫治疗药物程序性死亡受体1/程序性死亡配体1(PD-1/PD-L1)抑制剂发生不良反应的风险信号,促进此类药物在临床安全合理使用。方法收集美国食品与药品监督管理局(FDA)不良反应数据库中2014年9月1日至2022年9月30日的不良反应报告。经过数据标准化处理,使用报告比值比(ROR)法及数据交叉对比分析,对PD-1/PD-L1抑制剂的不良反应信号进行数据挖掘。结果获得PD-1/PD-L1抑制剂的不良反应报告106946份。经数据挖掘,有显著意义的不良反应风险信号2741个,其中帕博利珠单抗886个、纳武利尤单抗956个、阿替利珠单抗545个、度伐利尤单抗255个、阿维鲁单抗99个。全部风险信号共累及25个系统或器官,主要为神经系统疾病、胃肠系统疾病、感染类疾病等。报告数前20位的不良反应中未在说明书中出现的信号有22个。所有PD-1/PD-L1抑制剂均存在的风险信号包括自身免疫性结肠炎、肿瘤溶解综合征、血肌酸磷酸激酶升高、心肌病等。结论临床使用PD-1/PD-L1抑制剂时,应关注患者的神经系统功能、胃肠道症状以及可能出现的感染,根据患者情况进行个体化给药,以保障患者用药安全。
Objective To excavate the risk signals with immunotherapy drugs programmed death 1/programmed death ligand 1(PD-1/PD-L1)inhibitors using medical data in the real world,in order to promote the safety and rational usage of PD-1/PD-L1 inhibitors.Methods Adverse reactions in U.S.Food and Drug Administration(FDA)adverse event reporting system were collected from 01 September 2014 to 30 September 2022.After data standardization,the reporting odds ratio method(ROR)and cross analysis were used to explore the adverse reaction risk signals of PD-1/PD-L1 inhibitors.Results Totally 106946 adverse reactions reports of PD-1/PD-L1 inhibitors were collected,and 2741 significant risk signals were excavated,which included pembrolizumab(886),nivolumab(956),atezolizumab(545),durvalumab(255)and avelumab(99).All risk signals involved 25 systems/organs,mainly for nervous system disorders,gastrointestinal disorders,infections,etc.In the sequence of top 20,there were 22 signals that did not appear in the instruction.Risk signals presented in all PD-1/PD-L1 inhibitors included autoimmune colitis,tumour lysis syndrome,increase of blood creatine phosphokinase,cardiomyopathy,etc.Conclusion When using PD-1/PD-L1 inhibitors in clinical practice,attention should be paid to the patient's nervous system function,gastrointestinal symptoms and possible infections,and individualized administration should be carried out according to the patient's condition to ensure the safety of the patient.
作者
李军伟
宋玮娟
李艳艳
时磊
王延虹
LI Junwei;SONG Weijuan;LI Yanyan;SHI Lei;WANG Yanhong(Department of Pharmacy,the Fifth Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)
出处
《临床肿瘤学杂志》
CAS
2023年第7期615-620,共6页
Chinese Clinical Oncology
基金
河南省科技攻关资助项目(232102310493)。
