基于美国FDA不良事件报告系统数据库的利奈唑胺风险信号挖掘

Study on the Risk Signal Mining Related to Linezolid Based on the US Food and Drug Administration Adverse Event Reporting System

目的:挖掘利奈唑胺的不良事件(AE)信号,为临床安全应用提供参考。方法:收集美国FDA不良事件报告系统数据库2010年第2季度至2021年第3季度收录的利奈唑胺AE报告,采用报告比值比(ROR)法进行AE风险信号挖掘。结果:共收集到以利奈唑胺为首要怀疑(PS)药物的首选术语(PT)93个,7个PT在药品说明书中标记为“未知”,2个PT在药品说明书中标记为“罕见”,8个PT在药品说明书中标记为“少见”,1个PT(低血糖)在说明书中有提及但未进行分类。62个PT在药品说明书中未收录,其中10个与感染及侵染类疾病有关,9个与血液及淋巴系统疾病有关,7个与各类检查有关。结论:利奈唑胺上市后发生的AE与药品说明书当中收录的类别较为一致。临床使用利奈唑胺过程中应加强对已在说明书中标记为“未知”“罕见”“少见”的17个AE及低血糖风险的关注。本次共挖掘出63个新的可疑风险信号,需提高对该类可疑信号的关注。

Objective:To mine and analyze the adverse event(AE)signals of linezolid,so as to provide reference for clinical safety application.Methods:The AE reports on linezolid included in the FDA Adverse Event Reporting System(FAEAS)data from the second quarter of 2010 to the third quarter of 2021were collected,and the AE risk signals were explored by using the report odds ratio(ROR)method.Results:A total of 93 preferred terms(PT)with linezolid as the primary suspect(PS)drug were collected.Seven PTs were marked as“unknown”in the drug instructions,two PTs were marked as“rare”in the drug instructions,eight PTs were marked as“infrequent”in the drug instructions,and one PT(hypoglycemia)was mentioned in the drug instructions but not classified.62 PTs were not included in the package inserts,of which 10 were related to infection and infectious diseases,9 were related to blood and lymphatic system diseases,and 7 were related to various examinations.Conclusion:The AEs that occurred after the listing of linezolid are more consistent with the categories included in the instructions.During the clinical use,attention should be paid to the 17 AEs and the risk of hypoglycemia that have been marked as“unknown”“rare”and“infrequent”in the instructions.A total of 63 new suspicious risk signals were discovered this time,and more attention should be paid to such signals.