氟维司群所致血液及淋巴系统疾病不良反应风险信号挖掘研究及分析

Study and Analysis of Risk Signal Mining for Adverse Reactions in Hematologic and Lymphatic System Diseases after Marketing of Fulvestrant

目的 挖掘氟维司群血液和淋巴系统不良事件风险信号,为该药临床安全使用提供参考。方法 采用报告比值比法对美国FDA不良事件报告系统数据库中2004年1月至2022年9月上报的氟维司群的血液和淋巴系统不良事件进行挖掘和分析。结果 共获得氟维司群的血液和淋巴系统报告631份,血液和淋巴系统不良事件信号16个,主要表现为中性粒细胞减少、贫血、血小板减少、白细胞减等,仅有血小板减少为说明书已记载的,其余均为新的不良事件。结论 临床应用氟维司群时应加强血液和淋巴系统不良事件监测,特别是说明书未提及的,应及时做出干预。

OBJECTIVE To explore the risk signals of the hematologic and lymphatic adverse events of fulvestrant to provide reference for the safe clinical use of this drug.METHODS Blood and lymphatic adverse events of fulvestrant reported from January 2004 to September 2022 in the database of the FDA Adverse Event Reporting System were mined and analyzed using the reporting odds ration(ROR)method.RESULTS A total of 631 hematologic and lymphatic reports of fulvestrant were obtained,and a total of 16 hematologic and lymphatic adverse event signals of fulvestrant were obtained by the ROR method,which mainly manifested as neutropenia,anemia,thrombocytopenia,leukocytosis,and so on,and only thrombocytopenia was already documented in the specification,and the rest of them were new adverse events.CONCLUSION The monitoring of hematologic and lymphatic adverse events should be strengthened in clinical trials of fulvestrant,especially those not mentioned in the instruction manual,and timely intervention should be made.