哌柏西利的安全警戒信号检测与评价

Signals detection and evaluation of adverse reaction induced by palbociclib

目的:运用数据挖掘的方法检测哌柏西利的不良反应信号,为其临床合理应用提供参考。方法:采用比例失衡法中的报告比值比法(ROR)和比例报告比值法(PRR)对美国FDA不良事件报告系统(FAERS)中2015年第一季度至2019年第三季度共19个季度的报告进行关于哌柏西利的数据挖掘。结果:使用ROR法和PRR法均得到哌柏西利的不良反应信号283个,二次筛选并去除考虑肿瘤治疗无效引起的ADR信号后,2种方法得到208个完全重合信号。其中新的不良反应信号159个,主要集中在胃肠系统疾病(30个)、各类检查(26个)、呼吸系统、胸及纵隔疾病(22个)、各类神经系统疾病(15个)和皮肤及皮下组织类疾病(n=14个)。信号强度排名前五中有4个为血液及淋巴系统疾病。结论:通过ROR、PRR信号检测方法,发现哌柏西利药品说明书未涉及的新的不良反应信号159个,建议临床用药时考虑其可能引起的不良反应进行合理用药。

OBJECTIVE To detect and evaluate the signals of adverse drug reaction(ADR)induced by palbociclib based upon mining data and provide references forrational medicinal practice.METHODS Reporting odds ratio(ROR)and proportional reporting ratio(PRR)in disproportionality analysis were employed for detecting ADR signals of palbociclib in 19 quarterly reports of FDA Adverse Event Reporting System from the first quarter of 2015 to the third quarter of 2019.RESULTS A total of 83 ADR signals of palbociclib were detected by ROR/PRR.After secondary screening and removing ADR signals caused by ineffective treatment, 208 signals were completely corresponding by two methods.And 159 new ADR signals were concentrated in gastrointestinal system diseases(n=30),various examinations(n=26),respiratory system/thoracic/mediastinal diseases(n=22),various neurological diseases(n=15)and skin & subcutaneous tissue diseases(n=14).Four of top five in signal strength were disorders of blood and lymphatic system.CONCLUSION Through ROR/PRR,150 new ADR signals are not involved in the package insert of palbociclib.It suggests that possible adverse reactions should be considered during clinical drug dosing.