瑞戈非尼的不良反应信号挖掘与评价  

Signal detection and evaluation of adverse reactions induced by regorafenib

作　　者：龙霞[1] 干小红[1] 曾晓欢 LONG Xia;GAN Xiao-hong;ZENG Xiao-huan(Department of Pharmacy,Chengdu Fifth People's Hospital,Chengdu 611130;Department of Pharmacy,Southwest Medical University,Luzhou Sichuan 646000)

机构地区：[1]成都市第五人民医院药剂科,成都611130 [2]西南医科大学药学院,四川泸州646000

出　　处：《中南药学》2019年第10期1798-1802,共5页Central South Pharmacy

摘　　要：目的运用数据挖掘的方法检测瑞戈非尼的不良反应信号,为其临床的合理应用提供参考。方法采用比例失衡法中的报告比值比法(ROR)与比例报告比值法(PRR)对美国FDA不良事件报告系统(FAERS)中2012年第四季度至2018年第三季度共24个季度的报告进行关于瑞戈非尼的数据挖掘。结果使用ROR法和PRR法均得到瑞戈非尼的不良反应信号304个,二次筛选并去除考虑肿瘤治疗无效引起的ADR信号后,两种方法得到197个完全重合信号。其中新的不良反应信号149个,主要集中在胃肠系统(36个)、肝胆系统(24个)、皮肤及皮下组织(24个)和肾脏及泌尿系统(10个)。结论通过ROR、PRR信号检测方法,发现瑞戈非尼药品说明书未涉及的新的不良反应信号149个,建议临床用药时考虑其可能引起的不良反应合理用药。Objective To detect and evaluate the signal of adverse drug reactions induced by regorafenib via data mining and to provide references for safe medicinal practice. Methods Disproportionality analysis with reporting odds ratio(ROR) and proportional reporting ratio(PRR) was used to detect ADR signals of regorafenib in 24(from the fourth quarter of 2012 to the third quarter of 2018) quarterly reports from FDA Adverse Event Reporting System. Results Totally 304 adverse reaction signals of regorafenib were detected by both ROR and PRR. After secondary screening and removing ADR signals caused by ineffective treatment, 197 completely coincident signals were obtained by the two methods. Among them 149 were new ADR signals, with 36 in the gastrointestinal system, 24 in hepatobiliary system, 24 in the skin and subcutaneous tissue system, and 10 in the kidney and urinary system. Conclusion Through ROR and PRR, 149 new ADR signals are discovered and should be in included in the instruction of regorafenib. More possible adverse reactions should be taken into account in clinical drug use.

关 键 词：瑞戈非尼 药物不良反应 报告比值比法 比例报告比值法 信号挖掘 

分 类 号：R979.1[医药卫生—药品] R969[医药卫生—药学]