仑伐替尼的不良反应信号挖掘与评价

Signal mining and evaluation of adverse reactions induced by lenvatinib

目的利用美国食品药品管理局公共数据开放项目(openFDA)检索仑伐替尼的不良反应信号(ADR),为临床用药提供参考。方法提取美国FDA不良事件报告系统(FAERS)中自2015年2月13日至2020年6月20日的报告,采用比例报告比值法(PRR)和报告比值比法(ROR)2种不同挖掘方法对其进行关于仑伐替尼的ADR数据挖掘。结果通过使用PRR法和ROR法共得到89个信号,其中29个信号的ADR未在仑伐替尼的说明书中出现。结论仑伐替尼ADR信号的挖掘有利于提高医务人员对ADR的警惕性,促进药物上市后安全性评价,并为临床合理使用仑伐替尼提供参考和依据。

Objective To detect and evaluate the signal of adverse drug reactions(ADR)of lenvatinib from the FDA public data program(openFDA),so as to provide references for the rational use of this drug in clinical practice.Methods Disproportionality analysis with proportional reporting ratio(PRR)and reporting odds ratio(ROR)was used to mine ADR signals of lenvatinib reported in the FDA Adverse Event Reporting System from February 13,2015 to June 20,2020.Results Totally 89 ADR signals were obtained by both ROR and PRR methods,29 of which were not shown in the specification and label instruction of lenvatinib.Conclusion The mining of the ADR signal of lenvatinib is beneficial to improve the vigilance of medical staff to ADR and promotes the safety evaluation of the drug after its marketing,which provides reference and basis for the rational clinical use of lenvatinib.