目的 基于美国食品药品监督管理局不良事件报告系统数据库挖掘奥法妥木单抗及利妥昔单抗治疗多发性硬化(multiple sclerosis，MS)时的不良事件信号，以期为这2种药物临床安全应用提供更多参考。方法 提取奥法妥木单抗与利妥昔单抗上市后的不良事件报告形成分析数据集，采用比例失衡法结合贝叶斯法进行不良事件信号监测，筛选出满足阈值条件的不良事件并进行总结分析。结果 奥法妥木单抗组采集到不良事件报告72310条，有325个阳性信号，涵盖24个系统器官分类(system organ class，S0C)，主要涉及"全身性疾病及给药部位各种反应""各类神经系统疾病""各种肌肉骨骼及结缔组织疾病";利妥昔单抗组采集到不良事件报告23 203条，有311个阳性信号，涵盖25个SOC，主要涉及"各类损伤、中毒及操作并发症""感染及侵染类疾病""各类神经系统疾病"。除"胃肠系统疾病"及"眼器官疾病"外，这2种药物每个SOC级别内不良事件的分布均有显著差异。结论 奥法妥木单抗与利妥昔单抗在治疗MS时的不良事件发生风险有较大差异，临床应用时应注意用药监测。由于基于真实世界的研究难以进行定量分析，以上结论还需大样本的队列研究进行验证。
Identifying Adverse Events of Ofatumumab and Rituximab in the Treatment of Multiple Sclerosis Based on the FAERS Database
OBJECTIVE To investigate adverse event signals associated with ofatumumab and rituximab in the treatment of multiple sclerosis(MS),provide more evidences for the clinical safe medication based on the U.S.food and drug administration's adverse event reporting system(FAERS)data.METHODS Postmarking adverse event reports of ofatumumab and rituximab were extracted to form an analysis dataset.Disproportionality analysis combined with bayesian confidence propagation neural nework(BCPNN)was conducted for adverse event signal monitoring.Adverse events meeting threshold conditions were selected and summa-rized for analysis.RESULTS The ofatumumab group collected a total of 72 310 adverse event reports,of which 325 showed positive signals,covering 24 system organ classes(SOCs),involving"infections and infestations""nervous system disorders"and"musculo-skeletal and connective tissue disorders".The rituximab group collected 23 203 adverse event reports,with 311 showing positive sig-nals,covering 25 SOC,involving"injury,poisoning and procedural complications""infections and infestations"and"nervous system disorders".Except for"gastrointestinal disorders"and"eye disorders",both drugs exhibited significant differences in each SOC.CONCLUSION There are substantial differences in the risk of adverse events between ofatumumab and rituximab in the treatment of MS.Therefore,medication monitoring is required during the treatment.Due to the limitations of real-world studies for quantitative analysis,the above conclusions need to be validated through large-scale cohort studies.
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