摘要
Abstract
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, endo-crine 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 oc-currence of adverse reactions of patients and take timely measures to intervene in clinical medication.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Key words
Nivolumab/Reporting odds ratio method/Proportional reporting ratio method/Adverse reaction signal分类
医药卫生
