基于真实世界数据的硝苯地平不良反应信号挖掘研究

Data-mining of ADR signals for Nifedipine based on real world data

目的利用真实世界数据挖掘硝苯地平普通片和缓释片的不良反应(ADR)信号,并比较两者的安全性差异。方法采用报告比值比法(ROR)和比例报告比值法(PRR)对FDA不良事件报告系统(FEARS)数据2012年第四季度~2018年第二季度共23个季度的不良事件报告进行数据挖掘。结果使用ROR法共得到硝苯地平信号共54个,其中硝苯地平普通片35个,硝苯地平缓释片19个,两种剂型有5个共同信号,包括药物无效、药物不耐受、变态反应、心动过速和头痛。结论硝苯地平普通片特有的不良反应主要集中在新生儿和胎儿异常等,提示妊娠期妇女应该谨慎使用硝苯地平普通片。而硝苯地平缓释片特有的不良反应主要集中在肌肉和骨骼系统,提示肌肉骨骼疾患的患者在选择此药时应警惕。

Objective To mine the data of adverse drug reaction(ADR)signals of Nifedipine tablets and sustainedrelease tablets,and to compare the safety differences between them.Methods Measures of disproportionality were used to conduct data-mining of the data in FDA Adverse Event Reporting System,from the fourth quarter in 2012 to the second quarter in 2018,covering 23 quaters.Results Totally 54 ADR signals,including 35 ADR signals for Nifedipine tablets and 19 ADR signals for Nifedipine sustained-release tablets were found by ROR.Five signals were found in both dosage forms,including ineffective medicine,drug intolerance,allergic reaction,tachycardia,and headache.Conclusion The unique adverse reactions of Nifedipine tablets mainly concentrate on neonatal and fetal abnormalities,suggesting that pregnant women should be cautious in using Nifedipine tablets.Specific adverse reactions of Nifedipine sustained-release tablets mainly cover the muscle and skeletal system,implying that patients with musculoskeletal disorders should avoid this drug.