索拉非尼的不良反应信号挖掘

The data-mining of ADR signals for Sorafenib

目的为了挖掘分子靶向抗癌药索拉非尼的不良反应信号,为临床安全用药提供参考。方法利用比例失衡法中的报告比值比法(ROR)和比例报告比值法(PRR)对美国FDA不良事件报告系统(FAERS)2012年第四季度~2016年第四季度共17个季度的报告进行数据挖掘。结果使用ROR法与PRR法共得到索拉非尼不良反应信号777个,二次筛选后得到索拉非尼不良反应信号68个,主要集中在肿瘤、肝胆疾病、胃肠道疾病与皮肤疾病。结论本研究有效利用ROR法和PRR法挖掘出索拉非尼的不良反应信号;建议临床用药时,充分考虑索拉非尼可能导致的不良反应进行适合的用药。

Objective To excavate the adverse drug reaction signals of molecular targeted antitumor drug Sorafenib, in or der to provide references for safety medicinal practice. Methods Conduct data-mining on the reporting odds ratio（ROR）and proportional reporting ratio（PRR） in measures of disproportionality to the reports in 17 quarters（Q4, 2012-Q4, 2016）in FDA Adverse Event Reporting System（FAERS）. Results Seven hundred and seventy-seven Sorafenib adverse drug reaction signals were obtained with ROR and PRR methods. After the secondary screening, 68 Sorafenib adverse drug reaction signals were obtained, which were mainly concentrated in tumors, hepatobiliary, gastrointestinal and skin diseases.Conclusion In this study, ROR and PRR are effectively used to extract the adverse drug reaction signals of Sorafenib.It is recommended that the appropriate attentions should be paid to the possible adverse reactions caused by Sorafenib.