基于FAERS数据库的达雷妥尤单抗相关不良事件信号挖掘

Data mining for adverse events signals of daratumumab based on FAERS database

目的基于FAERS数据库挖掘达雷妥尤单抗相关的不良事件,为临床安全用药提供参考。方法收集FAERS数据库中2015年11月1日至2022年3月31日期间达雷妥尤单抗相关不良事件数据,采用报告比值比法(ROR)进行数据挖掘。结果共获得以达雷妥尤单抗为首要怀疑药物的不良事件报告3011份,其中老年患者(>65岁)报告数最多(994例,33.01%),报告国家以美国和日本为主。达雷妥尤单抗的不良事件涉及26个系统器官分类,频数较高的不良事件与药品说明书基本一致,阳性信号的不良事件共195个。报告数最多的不良事件是输液相关反应,且信号强度较高。达雷妥尤单抗说明书中未记载的不良事件包括骨髓功能衰竭、全血细胞减少症、肿瘤溶解综合征、骨髓抑制及溶血症等。结论基于FAERS数据库挖掘的达雷妥尤单抗不良事件与药品说明书基本一致,同时还发现潜在新的不良事件信号,有待进一步开展前瞻性研究确认其因果关系。

Objective To detect adverse events signals of daratumumab based on FAERS database,so as to provide refer⁃ences for its safe use in clinic.Methods We collected daratumumab-related adverse events data from November 1,2015 to March 31,2022 in the FAERS database,and employed the reporting odds ratio(ROR)method for data mining.Results A to⁃tal of 3011 adverse event reports were obtained with daratumumab as the primary suspected drug,with the highest number of reports among elderly patients(>65 years;994 cases,33.01%).The main reporting countries were the United States and Ja⁃pan.Adverse events of daratumumab involved 26 system organ classes,with high-frequency adverse events consistent with those in drug instructions.A total of 195 positive signals were identified.The most frequently reported adverse event was infu⁃sion related reaction,which also showed a high signal intensity.Undocumented adverse events included bone marrow failure,pancytopenia,tumor lysis syndrome,myelosuppression,hemolysis,etc.Conclusion Adverse events of daratumumab based on FAERS database are generally consistent with drug instructions and the results of clinical trials.Additionally,potential new adverse event signals has been found,Further prospective studies are needed to confirm the causal relationship.