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伊奈利珠单抗不良事件信号挖掘与分析
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| 篇名： | 伊奈利珠单抗不良事件信号挖掘与分析 |
| TITLE： | Signals mining and analysis of inebilizumab adverse events |
| 摘要： | 目的 挖掘并分析伊奈利珠单抗的不良事件信号，为临床安全合理用药提供参考。方法通过美国FDA不良事件报告系统（FAERS）数据库收集2020年第二季度至2024年第四季度的伊奈利珠单抗相关不良事件报告。通过《国际医学用语词典》26.0中的“首选术语（PT）”和系统器官分类（SOC）对不良事件进行标准化和归类。采用报告比值比（ROR）法和贝叶斯置信区间递进神经网络（BCPNN）法进行信号挖掘。结果共提取到以伊奈利珠单抗为首要怀疑药物的不良事件报告783份，涉及297例患者。不良事件报告主要来源于美国和日本，报告者以医生为主，患者中女性所占比例高于男性，年龄以45～64岁为主。采用ROR法和BCPNN法共筛选出29个不良事件信号，涉及12个SOC，共225份不良事件报告。报告份数居前5位的PT为头痛、恶心、疲劳、感染性肺炎及关节痛；信号强度排名前5位的PT分别为B细胞恢复、血免疫球蛋白G降低、椎体压缩骨折、COVID-19和急性呼吸窘迫综合征。29个不良事件信号中19个未在药品说明书中记载，涉及10个SOC，共107份不良事件报告，包括各类神经系统疾病、全身性疾病及给药部位各种反应、眼器官疾病等。结论使用伊奈利珠单抗进行治疗时，除可引起感染、免疫球蛋白降低、输液相关反应等药品说明书已记载的不良反应外，还可能引发B细胞恢复、椎体压缩骨折等潜在风险。临床在使用该药时应评估患者的感染风险与基线免疫状态，并密切监测相关指标，必要时考虑给予针对性预防措施。 |
| ABSTRACT： | OBJECTIVE To mine and analyze adverse event signals associated with inebilizumab， and to provide reference for safe and rational clinical use. METHODS Reports of adverse event related to inebilizumab were collected from the FDA adverse event reporting system （FAERS） database， from Q2 2020 to Q4 2024. Adverse events were standardized and categorized according to the preferred term （PT） and system organ class （SOC） of the Medical Dictionary for Regulatory Activities （MedDRA） version 26.0. Signals were mined using the reporting odds ratio （ROR） method and the Bayesian confidence propagation neural network （BCPNN） method. RESULTS A total of 783 adverse event reports with inebilizumab as the primary suspected drug were identified， involving 297 patients. Most reports originated from the United States and Japan， with physicians being the primary reporters. Female patients outnumbered males， and the most common age group was 45-64 years. Using the ROR method and BCPNN method， a total of 29 valid adverse event signals were detected， involving 12 SOCs and comprising 225 adverse event reports. The five most frequently reported PTs were headache， nausea， fatigue， infectious pneumonia and arthralgia. The five PTs with the strongest signal intensity were： B-cell recovery， decreased blood immunoglobulin G， spinal compression fracture， COVID-19 and acute respiratory distress syndrome. Among the 29 valid signals for adverse event， 19 were not documented in the drug package inserts， involving 10 SOCs and comprising 107 adverse event reports. These encompassed nervous system disorders， general disorders and administration site conditions， eye disorders， among others. CONCLUSIONS Inebilizumab treatment not only causes adverse events documented in the product information， such as infections， immunoglobulin reduction and infusion-related reactions but also leads to potential signals， including B-cell recovery， spinal compression fracture. When using this drug in clinical practice， the patient’s risk of infection and baseline immune status should be assessed， relevant indicators should be closely monitored， and targeted preventive measures should be considered when necessary. |
| 期刊： | 2026年第37卷第02期 |
| 作者： | 张嘉怡；刘琛；张晓彤 |
| AUTHORS： | ZHANG Jiayi，LIU Chen，ZHANG Xiaotong |
| 关键字： | 伊奈利珠单抗；药品不良事件；FAERS数据库；视神经脊髓炎谱系疾病 |
| KEYWORDS： | inebilizumab； adverse events； FAERS database； neuromyelitis optica spectrum disorders |
| 阅读数： | 6 次 |
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