摘要
目的通过对纳武利尤单抗不良反应的信号挖掘分析,为临床合理安全用药提供参考。方法利用报告比值比法(ROR)和比例报告比值法(PRR)对美国FDA不良事件报告系统(FAERS)2014年12月22日-2018年第四季度约16个季度的纳武利尤单抗相关报告进行数据挖掘。结果采用ROR法和PRR法进行计算,均得到456个信号,且信号完全重合,将有信号的不良反应进行二次筛选,共得到93个信号,其中42个信号的不良反应未在纳武利尤单抗说明书中出现。纳武利尤单抗累积不良反应数较多的系统为良性、恶性及性质不明的肿瘤(包括囊状和息肉状)3590个;呼吸系统、胸及纵膈疾病3137个;全身性疾病及给药部位1722个。同时挖掘出说明书收录不全之处,如检测到纳武利尤单抗可能引起感染、内分泌损害、神经系统紊乱等。结论纳武利尤单抗发生不良反应信号数较多的系统主要集中在内分泌、呼吸、外科及内科的各种操作与治疗等方面,建议临床用药时应注意监测患者的不良反应,及时采取干预措施。
Objective To provide reference for clinical rational and safe drug use by signal mining analysis on adverse reactions of nivolumab.Methods The reports of approximate 16 quarters,from December 22,2014 to the fourth quarter of 2018,were mined from the FDA Adverse Event Reporting System(FAERS)by using reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods.Results Using ROR method and PRR method,456 signals were obtained,and the signals coincided completely.Then the adverse reactions of signals were screened twice,and 93 signals were obtained.However,some adverse reactions from 42 out of the 93 signals did not appear in the instructions for nivolumab.The system with more cumulative adverse reactions number of nivolumab was 3590 in neoplasms benign,malignant and unspecified(incl.cysts and polyps),3137 in respiratory,thoracic,and mediastinal disorders,1722 in general disorders and administration site conditions.The inadequacies in the specifications of nivolumab were also found,such as the detection of infection,endocrine damage and nervous system disorders.Conclusion The system with more adverse reaction signals of navliumab mainly concentrated on the endocrine disorders,respiratory,surgical and medical procedures.It is suggested that relevant workers should pay attention to the occurrence of adverse reactions of patients and take timely measures to intervene in clinical medication.
作者
张佳颖
常壤丹
陈力
龙恩武
ZHANG Jiaying;CHANG Rangdan;CHEN Li;LONG Enwu(Department of Pharmacy,Personalized Drug Therapy Key Lab of Sichuan Province,Affiliated Hospital of University of Electronic Science and Technology of China/Sichuan Provincial People’s Hospital,Chengdu,Sichuan,610072,China;Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu,Sichuan,610041,China;Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu,Sichuan,610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children(Sichuan University),Ministry of Education,Chengdu,Sichuan,610041,China)
出处
《肿瘤药学》
CAS
2019年第5期798-803,共6页
Anti-Tumor Pharmacy
关键词
纳武利尤单抗
报告比值比法
比例报告比值法
不良反应信号
Nivolumab
Reporting odds ratio method
Proportional reporting ratio method
Adverse reaction signal
