基于美国FAERS数据的索磷布韦维帕他韦与艾尔巴韦格拉瑞韦不良事件安全警戒研究

Security alert of sofosbuvir/velpatasvir and elbasvir/grazoprevir adverse drug events based on FAERS

目的挖掘索磷布韦维帕他韦片、艾尔巴韦格拉瑞韦片上市后的不良事件信号,为临床安全用药提供参考。方法提取FAERS数据库2017年第一季度至2020年第三季度共15个季度的不良事件报告数据,利用报告比值比法和联合综合标准法对索磷布韦维帕他韦片、艾尔巴韦格拉瑞韦片的不良事件信号进行分析。结果筛选得到索磷布韦维帕他韦片172个信号,信号累计23个系统器官;艾尔巴韦格拉瑞韦片85个信号,信号累及21个系统器官。信号均集中于全身性疾病及给药部位各种反应、各类神经系统疾病、胃肠系统疾病等。其中索磷布韦维帕他韦片的不良事件中肾淤血信号强度最高,且头痛、胃食管反流病等不良事件的报告频次占比均大于0.5%。而艾尔巴韦格拉瑞韦片的不良事件中直肠穿孔的信号强度最高,且恶心、食欲减退等不良事件的信号频次占比大于0.5%。结论索磷布韦维帕他韦片和艾尔巴韦格拉瑞韦片不良事件累及系统器官分布类似,但在肾脏毒性、消化系统疾病和神经系统疾病等不良事件方面的差异值得进一步关注。

Objective To conduct data-mining of sofosbuvir/velpatasvir and elbasvir/grazoprevir adverse event signals after their marketing and to provide a reference for safe clinical medication.Methods The adverse event report data of 15 quarters(the first quarter of 2017 to the third quarter of 2020)were collected from the food and drug administration adverse event reporting system database.We used reporting odds ratio and the medicines and healthcare products Regulatory Agency methods to analyze the adverse event signals of sofosbuvir/velpatasvir and elbasvir/grazoprevir.Results Totally 172 signals of sofosbuvir/velpatasvir were detected,involving 23 systems and organs;85 signals of elbasvir/grazoprevir were detected,involving 21 system organ classes.The majority of signals included systemic diseases and various reactions at the site of administration,nervous system disorders and gastrointestinal disorders.Among the signals of sofosbuvir/velpatasvir,kidney congestion was the strongest,and the report rate of headaches and gastroesophageal reflux diseases was over 0.5%.Among the signals of elbasvir/grazoprevir,the rectal perforation was the strongest,and the reported rate of nausea and poor appetite was over 0.5%.Conclusion The systems and organs involved in the adverse events of sofosbuvir/velpatasvir and elbasvir/grazoprevir are relatively similar,but the difference in adverse events such as the renal toxicity,gastrointestinal disorders and nervous system disorders between the two drugs needs further attention.