基于FAERS对沙库巴曲缬沙坦不良反应的分析研究

目的： 通过挖掘美国食品药品监督管理局不良事件呈报系统（FAERS）数据库中关于沙库巴曲缬沙坦的相关数据，探讨该药潜在的不良反应，为临床安全用药提供依据。方法： 采用报告比值比法（ROR）和比例报告比值法（PRR）同时检测FAERS数据库中沙库巴曲缬沙坦的不良事件信号，检索时限从2015年第3季度该药上市至2019年第3季度共17个季度，并对结果进行分析研究。结果： 经过多重筛查，ROR法与PRR法得到信号均一致合计41个且挖掘出33个未在说明书收录的警戒信号。其中较强的信号主要集中在低血压、室性心动过速、血管性水肿、听觉迟钝、高钾血症等，系统器官分类（SOC）涉及信号个数最多的主要集中在神经系统疾病和心脏疾病等，同时也挖掘出该药可能引起认知功能障碍等不良事件。结论： 利用挖掘FAERS数据可较全面深入地分析研究沙库巴曲缬沙坦上市后的不良反应，进而有效地降低临床用药风险。

Analytical study of adverse reactions of sacubitril/valsartan based on FAERS

OBJECTIVE To explore the potential adverse reactions of sacubitril/valsartan by mining the relevant data of FDA database of Adverse Event Reporting System(FAERS) to provide rationales for clinical safe drug dosing.METHODS Reporting odds ratio(ROR) and proportional reporting ratio(PRO) were utilized for simultaneously detecting the adverse event signals of sacubitril/valsartan in the database of FAERS.The search time limit was from the third quarter of 2015 when the drug was launched to the third quarter of 2019.The results were analyzed for 17 quarters. RESULTS After multiple screenings,the signals obtained by ROR and PRR were consistent.A total of 41 and mined 33 warning signals were not listed in specification.Strong signals were predominantly concentrated in hypotension,ventricular tachycardia,angioedema,hypoacusis and hyperkalemia,etc.The largest number of signals involved in system organ class was concentrated in nervous system disorders and cardiac disorders,etc.Also the drug caused adverse events such as cognitive impairment,etc.CONCLUSION The method of mining FAERS data can comprehensively and thoroughly analyze the adverse reactions after marketing of sacubitril/valsartan so as to can effectively reduce the risk of clinical medication.