基于OpenFDA挖掘和分析贝伐珠单抗的不良反应

The Adverse Drug Reactions Induced by Voriconazole Based on OpenFDA

目的通过分析新型抗肿瘤药物贝伐珠单抗的药品不良反应事件信号,为临床安全用药提供参考。方法利用OpenFDA检索2004年1月至2021年7月贝伐珠单抗不良反应报告数据,采用报告比值比(ROR)法和比例报告比值法(PRR)挖掘贝伐珠单抗不良反应风险信号。结果共检索到贝伐珠单抗相关不良反应报告32693份,根据筛选条件检测出a≥3且ROR的95%CI下限>1的不良反应风险信号42个,涉及12个系统器官,其中蛋白尿、高血压、中性粒细胞减少等出现较强信号。结论基于OpenFDA数据库可方便快捷地对贝伐珠单抗不良反应相关信息进行全面挖掘分析。在临床使用过程中除应关注说明书提及的常见不良反应外,对间质性肺炎、胃肠穿孔、出血、栓塞等可引起的死亡情况也应高度关注。

Objective We sought to determine the adverse drug reaction(ADR)event signals of bevacizumab,a new anti-tumor drug,to provide reference for clinical safety.Methods The ADR reporting data for bevacizumab between January 2004 and July 2021 were retrieved through the FDA public data access program,the US Food and Drug Administration Public Data Open Project(OpenFDA),the reported ratio(ROR-RRB-method and the reported ratPRR-RRB-PRR)method were used to mine the adverse reaction risk signals of bevacizumab.Results Finally,32693 adverse reaction reports related to bevacizumab were found.According to the screening conditions,42 ADR risk signals with a≥3 and the 95%CI lower limit>1 of ROR were detected,involving 12 systemic organs,In which proteinuria,hypertension and neutrophil showed strong signals.Conclusion Based on OpenFDA database,we can mine and analyze the related information ADRs of bevacizumab conveniently and quickly.Moreover,we should reinforce the attention to the mortality caused by interstitial pneumonia,gastrointestinal perforation,bleeding and embolism,besides the common adverse reactions mentioned in the manual.