基于FAERS数据库的阿卡替尼不良反应事件信号挖掘

Data Mining for Adverse Events Signals of Acalabrutinib Based on FAERS Database

目的通过对阿卡替尼的药物警戒信号进行挖掘分析,探讨该药潜在的不良反应,为临床安全合理用药提供参考。方法检索FAERS数据库中有关阿卡替尼的相关数据,采用比例失衡法检测获得的药物警戒信号。结果提取到3155例以阿卡替尼为首要怀疑药物的不良反应事件报告,共检测出73个警戒信号,涉及15个系统器官分类,其中36个信号未被阿卡替尼药品说明书收录。阿卡替尼较强的信号主要集中在各种炎性反应、出血、贫血、挫伤和心房纤颤等,系统器官分类涉及信号个数最多的主要集中在血液和淋巴系统、试剂检查和感染及侵染类疾病等,同时也挖掘出该药可能引起心动过速、脆甲症等警戒信号。通过对性别差异相关不良事件进一步分析,发现有性别差异的高危信号共49个,男性患者应注意出血、心脏、泌尿系统、高血压等方面的不良反应,女性患者应注意肝功能、皮肤炎性反应等方面的不良反应。结论使用FAERS共挖掘出36个阿卡替尼说明书未提及的药物警戒信号,血液、感染及心脏方面的毒性需要特别关注,临床用药时应及时发现并进行有效防范,降低患者的用药风险。

Objective To explore the potential adverse reactions of acalabrutinib by mining and analyzing the pharmacovigilance signal of acalabrutinib,to provide a reference for clinically safe and rational drug use.Methods Data related to acalabrutinib in the FAERS database were searched,and pharmacovigilance signals were obtained using the disproportionality measurement.Results A total of 3,155 reports of adverse events with acalabrutinib as the primary suspected drug were extracted,and 73 warning signals were detected involving 15 system organ classifications,36 of which were not included in the drug instructions of acalabrutinib.The strong signals of acalabrutinib were mainly concentrated in various inflammatory and bleeding,anemia,contusion,atrial fibrillation,and so on.The largest number of system organ classification signals were focused on the blood and lymphatic system disorders,investigations,infections,and so on.In addition,the drug may cause tachycardia,brittle nails,and other warning signs.Through further analysis of gender-related adverse events,there were a total of 49 high-risk signals with gender differences found.Herein,male patients should pay attention to adverse reactions in bleeding,heart,urinary system,hypertension,and so on;meanwhile,female patients should be alert to adverse reactions in liver function,skin inflammation,and so on.Conclusion A total of 36 drug warning signs that are not mentioned in the instructions for acalabrutinib are mined using FAERS,and blood,infection,and cardiac toxicity require special attention.Thus,these signals should be detected promptly for effective prevention in clinical medication to reduce the risk of medication use for patients.